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Decree of the State Council of the People's Republic of China No. 680

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The Decisions on the Amendment of the Rules on Supervision and Administration of Medical Devices by the State Council are hereby promulgated and come into effect since the date of promulgation

The Decisions on the Amendment of the Rules on Supervision and Administration of Medical Devices by the State Council are hereby promulgated and come into effect since the date of promulgation.

Prime Minister Li Keqiang

May 4, 2017

 

Decisions on the Amendment of the Rules on Supervision and Administration of Medical Devices by the State Council

The Rules on Supervision and Administration of Medical Devices is amended as follows according to the decision of the State Council:

I. Article 18 is amended as “All clinical trials conducted for the medical devices shall comply with requirements of the quality control specifications on clinical trials for the medical devices, and in such institutions with appropriate conditions, which shall be registered in the food and drug regulatory authority of the people's governments of the province, autonomous region and special municipality which the trial proposer is located The food and drug regulatory authority accepting the filing of clinical trial shall notify the filing to the food and drug regulatory authority and the health and family planning authority at the same level where the clinical trial institution is located.

“The institutions conducting clinical trials for the medical devices shall adopt the record management approach. All conditions, record management methods and the clinical trial quality control specifications for such institutions shall be formulated and promulgated by the food and drug regulatory authority and the health and family planning authority under the State Council.”

II. Item 1 and 2 of Article 34 are combined as Item 1: “Medical device consumption units shall have warehouse and conditions conform to the specified variety and quantity of the medical device. Medical device consumption units shall enhance the training for their staff, and use medical device according to instruction for use and operational technical guidance.”

One item is added as Item 2: “Medical device consumption units shall have large medical equipment in accordance with the large medical equipment allocation plan made by the health and family planning authority under the State Council, meeting the functional level and clinic service needs. Such units shall also have relevant technical conditions, supporting devices and professional technicians with necessary qualifications and capabilities, and have been approved by the health and family planning authority of the people's governments at above provincial level, and have obtained large medical equipment allocation licence .”

One item is added as Item 3: “Rules on Allocation and Control of Large Medical Equipment shall be jointly formulated by the health and family planning authority and other relevant authority under the State Council. The catalogue of large medical equipment shall be proposed by the health and family planning authority and other relevant authority under the State Council, and be submitted to the State Council for approval before its official implementation”

III. Item 1 and 2 of Article 56 are combined as Item 1: “The food and drug regulatory authority shall strengthen and conduct inspection on the medical devices manufactured, distributed, and used by medical device manufacturers, distributors and consumption units. Inspection expenses and any other fees shall not be collected for the testing. The expenses required shall be enlisted in the government budget at the same level. The food and drug regulatory authority of the government shall timely publish medical device quality announcement according to the conclusion of the inspection. ”

One item is added as Item 2: “The health and family planning authority shall supervise and assess the usage status of large medical equipment, and do timely corrections and offer punishments according to the law once any violations against rules, or excessive inspection and treatment concerning such large medical equipment are found.”

IV. One item is added as Item 3 in Article 63: “Those randomly equipped with the large medical equipment without approval shall be ordered to stop such application by the health and family planning authority of the people's government at above county level, which will give a warning and confiscate all illegal revenue; if such illegal revenue is less than RMB 10,000, a penalty between RMB 10,000 and RMB 50,000 shall be given; if such revenue is over RMB 10,000, a penalty equal to 5~10 times the illegal revenue shall be given; under serious cases, the application of relevant responsible persons and institutions for using large medical equipment shall be rejected for 5 years.”

V. Item 1 of Article 64 is amended as: “Where any party obtains licenses for registration, production, marketing of medical devices, as well as applies large medical equipment and obtains the advertisement approval documents by providing false information or other deceptive means, such licenses shall be revoked by the original issuing authority, with a penalty between RMB 50,000 and RMB 100,000, the application of relevant responsible persons and institutions for using large medical equipment shall be rejected for 5 years

VI. One item is added as Item 2 in Article 66: “If the operators and consumption units of such medical devices have conducted checking of incoming goods and other obligations prescribed in this regulation, and can provide sufficient evidences to prove that they are not aware that the medical devices they have marketed and applied meet the conditions stated in above Article (I) and (III), and can provide the actual source of those goods, they can be exempted from relevant punishments, but the illegal medical devices they have marketed and applied shall be confiscated according to the law.”

VII. One item is added as Item 9 in Article 68: “(IX)The medical device consumption units violate the rules by applying large medical equipment and fail to guarantee the medical quality and security”; the original Item 9 is amended as Item 10.

VIII. Article 69 is amended as: “Those taking on medical device clinical trials against this regulation shall be ordered to correct or stop such trial immediately by the food and drug regulatory authority of the people's governments at above county level, and bear a penalty below RMB 50,000; for those ending with serious consequences, the direct managers and other relevant direct responsible persons shall be degraded, removed from their posts, or even dismissed; such institutions shall be banned from launching any professional medical device clinical trials within 5 years.

“The testing institutions offering false reports shall bear a penalty varying from RMB 50,000 to RMB 100,000 by the food and drug regulatory authority of the people's government at above county level; all illegal revenues, if any, shall be confiscated; the direct managers and other relevant direct responsible persons shall be removed from their posts, or even dismissed; such institutions shall be banned from launching any professional medical device clinical trials within 10 years.”

IX. Article 73 is amended as: “The food and drug regulatory authority, the health and family planning authority and their public staff shall strictly perform their administrative power of punishment based on the nature and details of the illegal conducts in accordance with the types and ranges of the punishments prescribed in this regulation. Detailed rules shall be formulated by the food and drug regulatory authority, the health and family planning authority according to their own duties.”

X. Rules are added in Article 76: “Large medical equipment refers to the large medical devices based on complex technology, requiring large investment, high operating cost, huge impact on the medical fee and shall be incorporated into the catalogue management.”

The decision comes into effect upon promulgation.

The Rules on Supervision and Administration of Medical Devices shall be accordingly amended according to the decision, and republished.

 

Regulations for the Supervision and Administration of Medical Devices

(Published by No. 276 Decree of the State Council on January 4, 2000, passed on 39th Executive Meeting of the State Council on February 12, 2014,.and amended based on the Decisions on the Amendment of the Rules on Supervision and Administration of Devices by the State Council on May 4, 2017,

 

Chapter I  General Provisions

 

Article 1  The Regulation hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety.

Article 2  All units or individuals engaged in the research and development, manufacture, distribution, use, supervision and administration of medical devices within the territory of the People’s Republic of China shall comply with the Regulation.

Article 3  The food and drug regulatory authority under the State Council is responsible for the supervision and administration of medical devices nationwide. Relevant authority under the State Council is responsible for the supervision and administration related to medical devices within the scope of their respective duties.

The food and drug regulatory authority of the local government at county level and above is responsible for the supervision and administration of medical devices in their administrative region. Relevant authority of the local government at county level and above is responsible for the supervision and administration related to medical devices within the scope of their respective duties.

The food and drug regulatory authority under the State Council shall coordinate with other relevant authorities under the State Council, in the implementation of planning and policies for medical device industry.

Article 4  The State shall classify and administrate medical devices based on risk level.

Class I Medical Devices are those with lower risk for which safety and effectiveness can be ensured through routine administration;

Class II Medical Devices are those with medium risk for which strict control is required to ensure their safety and effectiveness;

Class III Medical Devices are those with higher risk which special measures shall be taken and strict control is required to ensure their safety and effectiveness.

Evaluation on risk level of medical devices, shall take their intended use, structural characteristics, forms of operation, and other factors into consideration.

The food and drug regulatory authority under the State Council is responsible for stipulating medical devices classification principles and classification catalogue; conducting timely analysis and evaluation on medical devices risk level changes related to the manufacture, distribution, and use of medical devices; as well as adjusting classification catalogue. The formulated and adjusted classification catalogue shall include suggestions from manufacturers, distributers, consumption units and individual users of medical devices, and use international classification practices as reference. The classification catalogue shall be published to general public.

Article 5  Medical devices shall follow safe, effective and economized principle. The State shall encourage the research and development of medical devices, play the role under the market mechanism, boost medical device new technology’s application and generalization, and promote the development of medical device industry.

Article 6    Medical devices shall meet the mandatory national standard or mandatory industry standard when there are no relevant mandatory national standard available.

The catalogue of single-use medical devices will be stipulated, adjusted and published by the food and drug regulatory authority under the State Council in conjunction with the health and family planning authority under the State Council. The reusable medical devices ensured to be safe and effective shall not be listed into the catalogue of single-use medical devices. For reusable medical devices ensured to be safe and effective and are improved from single-use medical devices after the change of design, manufacturing process, disinfection or serialization technology shall be deleted from the catalogue of single-use medical devices.

Article 7    Medical device industry association should strengthen industrial self-discipline, promote credit system construction, urge enterprises to conduct manufacture and distribution activities in accordance with law and regulation, and lead enterprises’ integrity.

 

Chapter II  Medical Devices Registration and Filing

 

Article 8  Class I medical devices shall implement filing administration, Class II and Class III medical devices shall implement registration administration.

Article 9  To file a record for Class I medical devices and apply for registration of Class II and Class III medical devices, the following files shall be submitted:

(I) Risk analysis report of the product;

(II) Technical requirements of the product;

(III) Testing report of the product;

(IV) Clinical evaluation material;

(V) Sample of Instruction for use and label;

(VI) Quality management system documents related to research and development and manufacture.

(VII) Other necessary documents to demonstrate safety and effectiveness of the product.

The medical device registration applicant and filing applicant shall be responsible for the authenticity of the submitted documents.

Article 10  To file a record for Class I medical devices, the filing applicant shall submit files to the food and drug regulatory authority of the government of the municipality consisting of districts where the applicant is located. The testing report of product can be self-testing report from filing applicant; the clinical evaluation report does not need to include clinical trial report, it can be literature review or clinical practice data from substantially equivalent products that can be used to demonstrate safety and effectiveness of the medical devices.

The overseas manufacturer who export Class I medical devices to the territory of the People’s Republic of China, shall submit the certificate recognized or approved by the government of the Country (Region) of Origin that authorize the products as medical devices to launch in the market, and shall file a record through their representative office or agent within the territory of the People’s Republic of China to the food and drug regulatory authority under the State Council.

In case of any filing item is changed and is reflected in the filing content, the applicant shall apply for amendment filing with the original filing regulatory authority.

Article 11  To apply for registration of Class II medical devices, the registration applicant shall submit registration files to the food and drug regulatory authority of the government of the provinces, autonomous regions and municipalities directly under the central government where the applicant is located. To apply for registration of Class III medical devices, the applicant shall submit registration files to the food and drug regulatory authority under the State Council.

The overseas manufacturer who export Class II and Class III medical devices to the territory of the People’s Republic of China shall submit the certificate recognized or approved by the government of the Country (Region) of Origin that authorize the products as medical devices to launch in the market , the registration applicant shall register through their representative office or agent within territory of the People’s Republic of China with the food and drug regulatory authority under the State Council.

For Class II and Class III medical devices, the testing report shall be type testing report issued by testing institute of medical device; the clinical evaluation report shall include clinical trial report, except for the medical devices exempted from clinical trials based on requirements from article 17.

Article 12  The administrative department of the food and drug regulatory authority shall forward the registration application to technical evaluation department within 3 working days from the date of document acceptance. The department for technical evaluation shall submit evaluation result to the food and drug regulatory authority once the technical evaluation is completed.

Article 13  The administrative department of the food and drug regulatory authority shall make decision within 20 working days from the day of receiving evaluation result; for those complying with the requirements on safety and effectiveness, registration shall be approved and Registration Certificate for Medical Device shall be granted; for those not complying with the requirements, the registration will not be approved and the reasons shall be specified in written to the applicant.

The food and drug regulatory authority under the State Council shall organize and conduct quality management system inspection if they deem it is necessary during technical evaluation.

Article 14  In case that substantial change takes place on the design, raw materials, manufacturing process, intended use, forms of operation, etc. of the Class II and Class III medical devices already registered, which possibly affect the safety and effectiveness of medical devices, the registration applicant shall submit change application to the original registration authority; if non-substantial change occurs and will not affect the safety and effectiveness of the medical devices, the registration applicant shall file the change on record with the original registration authority.

Article 15  The valid period of the Registration Certificate for Medical Device is 5 years. If the registration shall be renewed upon the expiration of the valid period, the applicant should submit the application for license extension re-registration with the original registration authority 6 months before the license expiration.

Except for the circumstances specified in the following three items of this article, when the food and drug regulatory authority receive application for license extension re-registration, they shall made the decision before the expiration of the license; if no decision is made by the date of license expiration, it shall be considered as approval for license extension re-registration.

In case of any of the following circumstances, the license extension re- registration shall not be approved:

(I) Registration applicant fails to submit application for license extension re-registration within specified time;

(II) The mandatory standard for medical devices has been revised and the medical devices being re-registered cannot meet the new requirements.

(III) For medical devices intended to treat rare disease or applied for public health emergencies fail to finish the registration record part of the Registration Certificate for Medical Device within specified time.

Article 16  For medical devices newly invented not yet listed in the classification catalogue, applicant may directly apply for Class III medical devices registration according to this regulation, or determine the device classification according to the classification principles and apply for confirmation to the food and drug regulatory authority under the State Council, and then carry out registration or filing accordingly.

For those directly apply for the registration of Class III medical devices, the food and drug regulatory authority under the State Council shall determine the classification according to the risk level and timely put the medical devices into the classification catalogue for proper registration or filing. For those apply for classification determination, the food and drug regulatory authority under the State Council shall determine the classification of the medical devices and inform the applicant within 20 working days.

Article 17  It is not necessary to conduct clinical trial when filing for Class I medical devices. To apply for Class II and Class III medical devices registration, clinical trial shall be conducted; however, in any of the following circumstances, the clinical trial could be exempted:

(I) With definite operating principle, established design, mature manufacturing process, have no record for serious adverse event of substantially equivalent medical devices which have been marketed and clinically applied for years; and without changing the conventional purpose of use;

(II) The safety and effectiveness of the medical devices can be proven through non-clinical evaluation;

(III) The safety and effectiveness of the medical devices can be demonstrated through the analysis and evaluation on the data obtained from clinical trials or clinical application of the substantially equivalent medical devices.

The catalogue of the medical devices exempted from clinical trial shall be formulated, adjusted and published by the food and drug regulatory authority under the State Council.

Article 18 All clinical trials conducted for the medical devices shall comply with requirements of the quality control specifications on clinical trials for the medical devices, and in such institutions with appropriate conditions, which shall be registered in the food and drug regulatory authority of the people's governments of the province, autonomous region and special municipality which the trial proposer is located. The food and drug regulatory authority accepting the filing of clinical trial shall notify the filing to the food and drug regulatory authority and the health and family planning authority at the same level where the clinical trial institution is located.

The institutions conducting clinical trials for the medical devices shall adopt the record management approach. All conditions, record management methods and the clinical trial quality control specifications for such institutions shall be formulated and promulgated by the food and drug regulatory authority and the health and family planning authority under the State Council.

Article 19  The clinical trial of Class III medical devices with higher risk to human body shall be approved by the food and drug regulatory authority under the State Council before execution. The pre-approval catalogue of Class III medical devices for which clinical trial with higher risk to human body shall be formulated, adjusted, and published by the food and drug regulatory authority under the State Council.

The food and drug regulatory authority under the State Council shall conduct comprehensive analysis on the conditions such as equipment, professionals, and etc. of the institution undertaking clinical trial for medical device, the medical devices risk level, clinical trial protocol, comparative analysis report of clinical benefit and risk, etc. during the clinical trial review. The approved clinical trial shall be notified to the food and drug regulatory authority of the government of the province, autonomous region, and municipality directly under the central government and the health and family planning authority where the clinical trial applicant and the clinical trial institution is located.

 

Chapter III   Medical Devices Manufacture

 

Article 20  Engaging in the manufacture of medical devices shall meet the following requirements:

(I) Manufacture site, environmental conditions, manufacture equipment/apparatus, and technical professionals comply with the medical device manufacture;

(II) Have quality inspection department or have full-time inspectors and inspection equipment for manufactured medical device;

(III) Have management system to guarantee the quality of manufactured medical devices;

(IV) Have after-sales capacities comply with the manufactured medical device;

(V) Other requirements outlined on products research and development, and manufacturing process documents.

Article 21  To manufacture Class I medical devices, the manufacturer shall file a record and submit supporting files that demonstrate they are compliant with the specified requirements in Article 20 of this regulation to the food and drug regulatory authority of the government of the municipality consisting of districts where the manufacturer is located.

Article 22  To manufacture Class II and III medical devices, the manufacturer shall apply for Medical Device Manufacturing License and submit supporting files that demonstrate they are compliant with the specified requirements in Article 20 of this regulation and provide the corresponding Registration Certificate for Medical Device to the food and drug regulatory authority of provinces, autonomous regions and municipalities directly under the Central Government.

The food and drug regulatory authority accepting the application shall perform review within 30 working days from the date of acceptance and conduct inspection according to the requirements of the Good Manufacturing Practice for Medical Devices formulated by the food and drug regulatory authority under the State Council. For those complying with the requirements, the application shall be approved and the Medical Device Manufacturing License shall be granted; for those not complying with the requirements, the application shall not be approved and the reasons shall be specified in written to the applicant.

The valid period of the Medical Device Manufacturing License is 5 years. If extension is needed upon expiration, the procedures for extension shall be followed according to the provisions of related administrative licensing law.

Article 23  The Good Manufacturing Practice for Medical Devices shall clearly formulate the matters affecting the safety and effectiveness of medical device, such as the design and development, manufacturing equipment/apparatus and conditions, procurement of raw materials, manufacturing process control, enterprise institutional arrangement, staffing, etc.

Article 24  Medical device manufacturer shall follow the Good Manufacturing Practice for Medical Devices, establish and improve quality management system complying with their manufactured medical devices and ensure the effective operation; they shall strictly organize manufacture according to the registered or filed product technical requirements and ensure manufactured medical devices are compliant with mandatory standard and registered or filed product technical requirements.

Medical device manufacturer shall conduct self-inspection regularly according to the operation of quality management system and submit self-inspection report to food and drug regulatory authority of the people’s government of the province, autonomous region, or municipality directly under the central government where the enterprise is located.

Article 25  If the manufacturing conditions of the medical device manufacturer changes and do not comply with the requirements of Good Manufacturing Practice for medical devices, medical device manufacturer shall immediately take rectification; if the safety and effectiveness of the medical device may be affected, the medical device manufacturer shall immediately stop manufacturing activities and report to the food and drug regulatory authority of the government at county level.

Article 26  Medical devices shall use generic names. Generic name shall comply with the medical devices nomenclature principles formulated by the food and drug regulatory authority under the State Council.

Article 27  Medical devices shall have instruction for use and labels. The contents of the instruction for use and labels should be consistent with the relevant contents registered or filed.

The following items shall be indicated on the instruction for use and labels for medical devices:

(I) Generic name, model, and specification;

(II) Name and address of manufacturer, address of physical manufacturing site, and contact information;

(III) Serial number of product technical requirement;

(IV) Manufacturing date and shelf life or expiration date;

(V) Performance, main structure, and applicable scope of product;

(VI) Contraindications, precautions and other warnings or tips;

(VII) Instructions or illustrations for installation and use;

(VIII) Maintenance methods, special storage conditions and methods;

(IX) Other contents to be indicated as specified by product technical requirements.

Class II and Class III medical devices shall indicate the registration number of the Registration Certificate for Medical Device, and the name, address and contact information of the medical device registration applicant.

Medical device intended to be used by individual consumers shall have special instruction for safe use.

Article 28  If medical device is manufactured under authorization, the entrusting party shall be responsible for the quality of the medical device manufactured under authorization. The entrusted party shall be medical device manufacturers complied with provisions in this regulation and equipped with corresponding manufacturing conditions. The entrusting party shall strengthen the management on the manufacturing behavior of the entrusted party to ensure the manufacture is compliant with the regulation.

Implantable medical device with high risk shall not be manufactured under authorization, and a specific category shall be stipulated, adjusted and published by the food and drug authority under the State Council.

 

Chapter IV   Medical Devices Distribution and Use

 

Article 29  Those Engaged in medical devices distribution activities shall have premises and storage conditions adapting to their distribution scale and scope, and shall have quality management system and department or staff adapting to their distributed medical device.

Article 30  The distributor who engaged in distribution of Class II medical devices shall file a record and submit supporting documents that prove they conform to conditions specified in Article 29 of the regulation to the food and drug regulatory authority of the government of the municipality consisting of districts municipalities where the distribution enterprise is located.

Article 31  The distributor engaged in the distribution of Class III medical devices shall apply for distribution permission and submit supporting documents that prove they conform to conditions specified in Article 29 of the regulation to the food and drug regulatory authority of the government of the municipality consisting of districts municipalities where the distribution enterprise is located.

The food and drug regulatory authority accepting the application for distribution permission shall conduct inspection within 30 working days from the date of acceptance; if necessary, organize verification. For those meeting specified conditions, the application will be approved and the Medical Device Distribution License shall be granted; for those not complying with the specified conditions, the application will not be approved and the reasons shall be specified in written to the applicant.

The valid period of the Medical Device Distribution License is 5 years. If extension is needed upon expiration, the procedures for extension shall be followed according to the provisions of related administrative licensing law.

Article 32  Medical device distributer and consumption unit shall check the qualification of the supplier and evidential document when purchasing medical devices, and establish purchase inspection recording system. The distributor engaging in wholesale service of Class II and Class III medical devices and retail business of Class III medical devices should also establish sales recoding system.

The items of recording include:

(I) Name, model, specification, and quantity of medical device;

(II) Batch number, shelf life, and date of sale of medical devices;

(III) Name of the device manufacturer;

(IV) Name, address and contract of supplier or purchaser;

(V) Numbers of relevant evidential documents.

Purchase inspection record and sales record should be authentic and kept within the duration indicated in the provisions of the food and drug regulatory authority under the State Council. The state encourages enterprises use advanced technic for recording.

Article 33  The transportation and storage of medical devices shall conform to the requirements of medical devices instruction for use and labels; in case of special requirements on temperature, humidity, and other environmental conditions, appropriate measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 34  Medical device consumption units shall have warehouse and conditions conform to the specified variety and quantity of the medical device. Medical device consumption units shall enhance the training for their staff, and use medical device according to instruction for use and operational technical guidance.

Medical device consumption units shall have large medical equipment in accordance with the large medical equipment allocation plan made by the health and family planning authority under the State Council, meeting the functional level and clinic service needs. Such units shall also have relevant technical conditions, supporting devices and professional technicians with necessary qualifications and capabilities, and have been approved by the health and family planning authority of the people's governments at above provincial level, and have obtained large medical equipment allocation licence .

Rules on Allocation and Control of Large Medical Equipment shall be jointly formulated by the health and family planning authority and other relevant authority under the State Council. The catalogue of large medical equipment shall be proposed by the health and family planning authority and other relevant authority under the State Council, and be submitted to the State Council for approval before its official implementation.

Article 35  Medical device consumption units shall process disinfection and management according to the guidance issued by the health and family planning authority under the State Council.

Single-used medical device shall not be reused; the used single-use medical device shall be destroyed according to relevant provisions of the state.

Article 36  Medical device consumption units shall take regular inspection, verification, calibration and maintenance for medical device which the above action need to be taken and record, analyze and evaluate relevant information according to the instruction for use to ensure the safety and effectiveness; for large scale medical equipment with long using duration, medical device consumption units shall establish using record for each equipment, record the use, maintenance, transfer, actual using time, and other related information. The record shall be kept for at least 5 years after the termination of medical device’s use period.

Article 37  Medical device consumption unit shall keep the original purchasing record material for Class III medical device and ensure information traceability.

Those using the large scale medical equipment, implantable and interventional medical device, shall put the name, key technical parameters and other necessary information related to the safe use of medical device into clinical cases or other records.

Article 38  The medical device consumption units shall stop use the medical device immediately once it is known there is a safety risk, and inform manufacturer or other institutions responsible for the quality of product to repair the device in question; if the repaired medical device still cannot meet the safety and effectiveness standard, they shall not be used.

Article 39  The food and drug regulatory authority and health and family planning authority shall conduct supervision and management respectively on the quality of medical devices and the using behavior of medical devices according to respective responsibilities.

Article 40  Medical device distributors and consumption units should not distribute or use any medical devices without registration or conformity certificate, or use expired, invalid and phased out medical devices.

Article 41  In case of transfer of medical devices between medical device consumption units, the transferor shall ensure the safety and effectiveness of medical devices. Expired, invalid, phased out, and non-conforming medical devices shall not be transferred.

Article 42  Imported medical devices shall be the ones registered or filed as specified in Chapter II of the regulation.

Imported medical devices shall have Chinese instruction for use and Chinese labels. The instruction for use and labels shall comply with this regulation and requirements of relevant mandatory standard. The medical device’s country of origin, agent’s name, address, and contact information should be listed in the instruction for use. Medical devices without Chinese instructions for use and Chinese labels or the instructions for use and labels not complying with the provisions in this regulation shall not be imported.

Article 43  Entry-exit inspection and quarantine authority shall conduct inspection on imported medical devices according to law and regulation; medical devices failed the inspection shall not be imported.

The food and drug regulatory authority under the State Council shall timely notify the registration and filing information of imported medical devices to the state entry-exit inspection and quarantine authority. The entry-exist inspection and quarantine authority where the import port is located should timely circulate customs clearance of imported medical devices to the food and drug regulatory authority of the government of the municipality consisting of districts.

Article 44  The manufacturers exported medical device shall ensure their products comply with the requirements of importing country (region).

Article 45  Medical device advertisement should be authentic and legitimate without spurious, exaggerated, and misleading contents.

Medical device advertisement shall be inspected and approved by the food and drug regulatory authority of governments of the provinces, autonomous regions, and municipalities directly under the central government where medical device manufacturer or agent of imported medical devices is located, and the approval document for medical device advertisement shall be obtained. Advertiser shall verify the approval document of the advertisement and its authenticity in advance and shall not release medical device advertisement without approval, or the authenticity of the approval has not been verified, or the content is not consistent with the approval document. The food and drug regulatory authority of governments of the provinces, autonomous regions, and municipalities directly under the central government shall make public and timely update towards the catalog and contents of the medical device advertisements approved.

For the medical devices instructed with suspension of manufacture, sale, import and use by the food and drug regulatory authority at province level and above, the advertisement shall not be released during the suspension period.

The measures for medical device advertisement inspection shall be formulated by the food and drug regulatory authority under the State Council in conjunction with the industrial and commercial administrative authority under the State Council.

 

Chapter V  Treatment of Adverse Event and Medical Devices Recall

 

Article 46  The state shall establish medical device adverse event monitoring system, timely collect, analyze, evaluate, and control medical device adverse event.

Article 47  Medical device manufacturers, distributors and consumption units shall conduct adverse event monitoring on their manufactured, distributed or used medical devices accordingly; if medical device adverse event or suspected adverse event is found, it shall be reported to the medical device adverse event monitoring technical institution according to the related provisions of the food and drug regulatory authority under the State Council.

Any units or individuals have right to report adverse event or suspected adverse event to the food and drug regulatory authority or to the technical institution of medical device adverse event monitoring.

Article 48  The food and drug regulatory authority under the State Council shall strength the construction for medical device adverse event monitoring information and networking system.

The medical device adverse event monitoring institutions shall strengthen the monitoring on medical device adverse event information and actively collect adverse event information; if adverse event is found or adverse event report is received, medical device adverse event monitoring institutions shall timely verify, investigate, analyze, and conduct evaluation on the adverse event, and put forward suggestions to the food and drug regulatory authority and health and family planning authority.

Medical device adverse event monitoring institution shall publicize its contact information, facilitate medical device manufacturers and distributors and using units report adverse events.

Article 49  The food and drug regulatory authority shall timely take controlling measures including releasing warning information and instructing suspension on manufacture, sales, import, and use, etc. according to the evaluation results of the medical device adverse event.

The food and drug regulatory authority of the government at province level and above shall organize timely investigation and treatment on the adverse events of medical devices causing emergent and group severe injury or death in conjunction with the competent health and family planning authority and other relevant authority at the same level, and organize strengthened monitoring of similar kind of medical devices.

Article 50  Medical device manufacturers, distributors and consumption units shall coordinate with related authorities in the investigation on adverse event conducted by medical device adverse event monitoring institution and the food and drug regulatory authority.

Article 51  In any of the following circumstances, the food and drug regulatory authority of the government at province level and above shall organize re-evaluation on the medical devices registered:

(I) Cognitional change of the safety and effectiveness of medical devices according to the development of scientific research;

(II) The monitoring and evaluation results of medical device adverse event indicate that the medical device may have defect;

(III) Other circumstances requiring re-evaluation as specified by the food and drug regulatory authority under the State Council.

If the re-evaluation results indicate that the safety and effectiveness of registered medical devices cannot be guaranteed, the Registration License for Medical Device shall be revoked by the original issuing authority and made public. The medical device which license has been revoked shall not be manufactured, imported, sold or used.

Article 52  If medical device manufacturers find that the medical devices manufactured do not meet mandatory standards, product technical requirements registered or filed or have other deficiencies, they shall immediately stop manufacturing, notify relevant manufacturers, distributors and consumption units, and consumers to stop distributing and using the medical device, recall marketed medical device and take remedy, destruction, and other measures appropriately, record relevant situations, release relevant information, and report recall and treatment of medical devices to the food and drug regulatory authority as well as the competent health and family planning authority.

In case the circumstance as specified in preceding clause exist with the medical device distributed, medical device distributor shall immediately stop distribution, notify relevant manufacturers, distributors, consumption units, and consumer, record matter concerning the stop distribution and notification. If medical device manufacturer deems that the medical device shall be recalled according to the provisions of the preceding clause, the medical device shall be immediately recalled.

If medical device manufacturers and distributors fail to implement recall or stop distribution according to the provisions in this regulation, the food and drug regulatory authority may instruct the distributor to recall or stop distribution.

 

Chapter VI   Supervision and Inspection

 

Article 53  The Food and drug regulatory authority shall strengthen supervision and inspection on the registration, filing, manufacturing, distribution and use activities of medical devices and conduct focused supervision and management on the following matters:

(I) Whether medical device manufacturer organizes manufacture according to the registered or filed product technical requirements;

(II) Whether medical device manufacturer can maintain effective operation of its quality management system;

(III) Whether the manufacture and distribution conditions of medical device manufacturer and distributor can meet statutory requirements sustainably.

Article 54  The Food and drug regulatory authority has the following authority in supervision and inspection:

(I) Enter sites and carry out on-site inspection and take samples;

(II) Review, copy, seal up, and detain relevant contract, bill, account book and other relevant materials;

(III) Seal up and detain the medical devices not complying with statutory requirements, illegally used parts and components, raw materials, and tools and equipment used for illegal manufacturing of medical devices;

(IV) Seal up the sites engaging in manufacturing and distribution activities of medical devices in violation of the provisions of this regulation.

During supervision and inspection, the food and drug regulatory authority shall show law enforcement certificate and safeguard trade secrets of the unit being inspected.

Relevant units and individuals shall coordinate with the supervision and inspection of food and drug regulatory authority and shall not conceal relevant matters.

Article 55  For the medical devices that are harmful to human body or proven as possibly harmful to human health, the food and drug regulatory authority may adopt emergency control measures to suspend medical device manufacture or import, distribution and use.

Article 56 The food and drug regulatory authority shall strengthen and conduct inspection on the medical devices manufactured, distributed, and used by medical device manufacturers, distributors and consumption units. Inspection expenses and any other fees shall not be collected for the testing. The expenses required shall be enlisted in the government budget at the same level. The food and drug regulatory authority of the government shall timely publish medical device quality announcement according to the conclusion of the inspection.

The health and family planning authority shall supervise and assess the usage status of large medical equipment, and do timely corrections and offer punishments according to the law once any violations against rules, or excessive inspection and treatment concerning such large medical equipment are found.

Article 57 Unified management shall be implemented on the qualification verification of medical device testing institution according to relevant national provisions. Only the testing institution identified by the certification and accreditation regulatory authority under the State Council together with the food and drug regulatory authority under the State Council can implement testing on medical devices.

If the food and drug regulatory authority need to conduct testing on medical devices during law enforcement, it shall entrust the medical device testing institution with qualification to conduct testing and pay relevant expenses.

If the party concerned has any objection against the testing conclusion, it may select qualified medical device testing institution for recheck within 7 working days from receiving the conclusion. The medical device testing institution undertaking recheck shall work out recheck conclusion within the time specified by the food and drug regulatory authority under the State Council. The recheck conclusion shall be final conclusion.

Article 58 For medical devices possibly containing harmful substance or with the design, raw materials, and manufacturing process changed without authorization and may have potential safety issues, which testing cannot be conducted follow the testing items and methods specified in national standard or industrial standard, the medical device testing institutions can conduct testing by adding appropriate testing items and methods; upon approval gain from the food and drug regulatory authority under the State Council, the conclusion of the testing obtained through above supplementary testing items and methods may be used as the basis for the food and drug regulatory authority to determine the quality of medical devices.

Article 59 The food and drug regulatory authority of the people’s government of the municipality established with districts and at the level of country shall strengthen the supervision and management on medical device advertisement; in case of finding the medical device advertisement without approval or altered the contents of the approved contents, shall report to the food and drug regulatory authority of the people’s government of the provision, autonomous region, and municipality directly under the central government where it is located and make it public.

Industrial and commercial administrative authority shall conduct supervision and inspection on medical device advertisement and investigate and deal with illegal act according to provisions of the laws and administrative regulations related to the supervision of advertisement. If the act of illegal release of medical device advertisement is found, the food and drug regulatory authority raise suggestions and forward it to the industrial and commercial administrative authority at the same level according to relevant procedures.

Article 60 The food and drug regulatory authority under the State Council shall establish unified medical device supervision and management information platform. The Food and drug regulatory authority shall timely publish supervision and management information including medical devices administrative licensing, filing, inspection, investigation on illegal act through the information platform according to law. However, the information involving trade secrets of the client shall be kept confidential.

The food and drug regulatory authority shall establish credit archive system for medical devices registration applicant and filing applicant, manufacturers, distributors and consumption units, and increase the supervision and inspection frequency on units that have a shaky credit history.

Article 61 The food and drug regulatory authority and relevant authorities shall public contact information; accept consultation, complaint, and reporting. The food and drug regulatory authority and relevant authorities shall timely reply upon receiving consultation relating to medical device supervision and management; timely verify, handle and reply upon receiving complaint and reporting. The consultation, complaint, reporting and their reply, verification, and treatment shall be properly recorded and kept.

Once the reporting of medical device development, manufacturing, distribution, and use is confirmed, the food and drug regulatory authority and relevant authorities shall give reward to the informer.

Article 62 When the catalog specified in this regulation and the policies relating to medical device supervision and management are formulated, adjusted or changed, the food and drug regulatory authority under the State Council shall solicit public opinion; by way of hearing, discussion meeting, etc., hear the opinions from experts, medical device manufacturers, distributors and consumption units, consumers, and relevant organizations, etc.

 

Chapter VII   Legal Liability

 

Article 63 In any of the following circumstances, the food and drug regulatory authority of the government at county level and above shall confiscate the illegal income, the medical devices illegally manufactured and distributed, and the tools, equipment, raw materials, and other articles used for illegal production and distribution; if the value of the medical devices illegally manufactured and distributed is less than RMB 10,000, a fine above RMB 50,000 but less than RMB 100,000 shall be imposed; if the value of the medical devices is above RMB 10,000, a fine more than 10 times but no more than 20 times of the value of the goods shall be imposed; in serious cases, the Medical Device Manufacturing License and Medical Device Distributing License shall be revoked by original issuing authority and the license application of medical devices submitted by relevant responsible person and enterprise shall not be accepted within five years:

(I) Manufacture and distribute Class II and Class III medical devices without obtaining the Registration Certificate for Medical Device;

(II) Engage in the manufacturing activities of Class II and Class III medical devices without permission;

(III) Engage in the operating activities of Class III medical devices without permission.

In serious cases for Item 1, the Medical Device Manufacturing License and Medical Device Distributing License shall be revoked by original issuing authority.

Those randomly equipped with the large medical equipment without approval shall be ordered to stop such application by the health and family planning authority of the people's government at above county level, which will give a warning and confiscate all illegal revenue; if such illegal revenue is less than RMB 10,000, a penalty between RMB 10,000 and RMB 50,000 shall be given; if such revenue is over RMB 10,000, a penalty equal to 5~10 times the illegal revenue shall be given; under serious cases, the application of relevant responsible persons and institutions for using large medical equipment shall be rejected for 5 years.

Article 64 Where any party obtains licenses for registration, production, marketing of medical devices, as well as applies large medical equipment and obtains the advertisement approval documents by providing false information or other deceptive means, such licenses shall be revoked by the original issuing authority, with a penalty between RMB 50,000 and RMB 100,000, the application of relevant responsible persons and institutions for using large medical equipment shall be rejected for 5 years.

In case of falsifying, altering, buying or selling, leasing, and lending relevant medical device licenses, the licenses shall be taken back or revoked by the original issuing authority and the illegal income shall be confiscated; if the illegal income is less than RMB 10,000, a fine above RMB 10,000 but less than RMB 30,000 shall be imposed; if the illegal income is more than RMB 10,000, a fine at more than 3 times but less than 5 times of the illegal income shall be imposed; in case of constituting violation of the administration of public security, the public security punishment shall be imposed by public security authority according to law.

Article 65 For those who fail to file the information according to the provisions in this Regulation, the food and drug regulatory authority of the government at county level and above shall order them to make corrections within a time limit; If no correction is made by the given timeline, the list of relevant responsible person and enterprises and the name of product shall be made public and a penalty below RMB 10,000 may be imposed.

For those providing spurious filing materials, the list of relevant responsible person and enterprises and the name of product shall be made public by the food and drug regulatory authority of the government at county level; in serious cases, the directly responsible person shall not be engaged in the manufacture and trading of medical devices within 5 years.

Article 66 In any of the following circumstances, the food and drug of the government at county level and above shall instruct the party concerned to make correction, confiscate illegally manufactured, distributed or used medical devices; Those with the value of illegally manufactured, distributed or used medical devices less than RMB 10,000 shall be imposed a fine of more than RMB 20,000 and less than RMB 50,000 Yuan; Those with the value of illegally manufactured, distributed or used medical devices more than RMB 10,000 shall be imposed a fine of not less than 5 times of the value of medical devices and less than 10 times of the value of medical devices; in serious cases, the authority shall not accept the manufacture or distribution application from relevant responsible person and enterprises:

(I) Manufacture, distribute and use medical devices that are not conforming to the mandatory standards or product technical requirements registered or filed;

(II) Manufacturer failed to organize medical device manufacture to the product technical requirement registered or filed, or failed to established or distribute by a quality management system according to the provisions in the Regulation;

(III) Distribute and use the medical devices without qualified certificate, or use expired, invalid and obsolete certificate, or use the medical devices not legally registered;

(IV) The manufacturer refuse to recall or stop distribution of medical devices even though they are ordered by the food and drug supervision and management depart;

(V) Authorize manufacture to the manufacturers that do not have the conditions specified in this regulation, or fail to manage the manufacture behavior of the entrusted party according to the provisions in this Regulation.

If the operators and consumption units of such medical devices have conducted checking of incoming goods and other obligations prescribed in this regulation, and can provide sufficient evidences to prove that they are not aware that the medical devices they have marketed and applied meet the conditions stated in above Article (I) and (III), and can provide the actual source of those goods, they can be exempted from relevant punishments, but the illegal medical devices they have marketed and applied shall be confiscated according to the law.

Article 67 In any of the following circumstances, the food and drug regulatory authority of the government at county level and above shall instruct the party concerned to make correction, and a fine above RMB 10,000 but less than RMB 30,000 shall be imposed; in serious case, the manufacture shall be instructed to stop business until the Medical Device Manufacturing License or the Medical Device Distributing license is revoked by the original issuing authority:

(I) The medical device manufacturers do not have manufacture conditions in accordance with requirements of medical devices quality management system but fail to take rectification measures, stop manufacture or report;

(II) Manufacture and distribute medical devices with the instructions and labels not complying with the provisions of this regulation;

(III) Failure to transport and/or store medical devices according to the requirements indicated on the instructions and labels of medical devices;

(IV) Transfer expired, invalid, phase-out or unqualified medical devices.

Article 68 In any of the following circumstances, the food and drug regulatory authority of the government at county level and above and competent health and family planning authority shall instruct the party concerned to make correction and give a warning according to their respective responsibilities; in case the concerned party refused to make correction, a fine above RMB 5,000 but less than RMB 20,000 shall be imposed; in serious cases, the manufacture shall be stopped to the extent that the Medical Device Manufacturing License or the Medical Device Distributing license is revoked by the original issuing authority:

(I) Medical device manufacturer fails to submit quality management system self-inspection report according to the requirements;

(II) Medical device distributor and Consumption unit fail to establish and implement medical device stock inspection and recording system according to the provisions in this regulation;

(III) Class II and Class III medical device distributor engaged in wholesale business and Class III medical devices distributor engaged in retail business fail to establish and implement sale record system according to the provisions in this regulation;

(IV) Medical Device consumption unit fails to process the reusable medical devices according to the provisions regarding device serialization and management;

(V) Medical Device consumption unit that re-use single-use medical devices, or fails to destroy used single-use medical devices according to related provisions;

(VI) Medical devices consumption unit fails to examine, inspect, calibrate, maintain the medical devices that routinely need to be examined, inspected, calibrated and maintained according to the instruction for use of medical devices, take records and conduct timely assessment and evaluation to ensure that the device is in good condition;

(VII) Medical devices consumption unit fails to maintain the original purchase record of Class III medical device or fails to add the capital equipment and implementable and intervene device related information into the medical record;

(VIII) Medical devices consumption unit fails to stop using, call for device aftersales maintenance when figure out the device in use might have potential safety risks, or keep using the device still cannot meet related safety standards after examine and repair;

(IX) The medical device consumption units violate the rules by applying large medical equipment and fail to guarantee the medical quality and security;

(X) Medical device manufacturers, distributors and using units fail to conduct adverse event monitoring according to the provisions of this regulation, fail to report adverse event according to requirements, or refuse to coordinate the investigation on adverse event conducted by medical device adverse event monitoring technical institution and food and drug regulatory authority.

Article 69 Those taking on medical device clinical trials against this regulation shall be ordered to correct or stop such trial immediately by the food and drug regulatory authority of the people's governments at above county level, and bear a penalty below RMB 50,000; for those ending with serious consequences, the direct managers and other relevant direct responsible persons shall be degraded, removed from their posts, or even dismissed; such institutions shall be banned from launching any professional medical device clinical trials within 5 years.

The testing institutions offering false reports shall bear a penalty varying from RMB 50,000 to RMB 100,000 by the food and drug regulatory authority of the people's government at above county level; all illegal revenues, if any, shall be confiscated; the direct managers and other relevant direct responsible persons shall be removed from their posts, or even dismissed; such institutions shall be banned from launching any professional medical device clinical trials within 10 years.

Article 70 If medical device testing institution issues spurious testing report, the testing qualification shall be revoked by the qualification awarding authority; and the qualification verification will not be accepted within 10 years; a fine above RMB 50,000 but below RMB 100,000 shall be imposed by the food and drug regulatory authority of the government at county level and above; if there is any illegal income, the illegal income shall be confiscated; the punishment of dismissal or discharge will be imposed on the competent person directly responsible to the clinical trial and other persons with direct responsibility according to law. If the punishment of discharge is imposed, such persons shall not engage in the inspection of medical devices within 10 years from the date when the punishment decision is made.

Article 71 In case of violating the provisions of this regulation, such as releasing medical device advertisement without obtaining approval document, or releasing medical device advertisement without verifying the authenticity of approval document in advance, or releasing medical device advertisement with inconsistent contents compare to the approved one, the penalty shall be imposed by industrial and commercial administrative authority according to the provisions of the laws and regulations on advertisement.

In case of falsifying the contents of the medical device advertisement approved, the medical device advertisement approval document shall be revoked by the original issuing authority and its advertisement application will not be accepted within 2 years.

The food and drug regulatory authority of the government at province level and above shall decide to suspend the sales of the medical device and make public if concerned party publishes spurious medical device advertisement; if the medical device is still sold to public, the food and drug regulatory authority of the government at county level and above shall confiscate illegally marketed medical devices, and a fine above RMB 20,000 but below RMB 50,000 shall be imposed.

Article 72 Medical device technical review institutions and medical device adverse event monitoring institutions fail to carry out the work according to the provisions in this regulation, or have been seriously irresponsible which results in major mistakes in evaluation and monitoring, the food and drug regulatory authority of the government at county level and above shall instruct them make correction, circulate a notice of criticism, or give a warning; in case of serious consequences are caused, the punishment of demotion, dismissal or discharge shall be imposed on the competent person directly responsible to the institution and other directly responsible persons according to law.

Article 73 The food and drug regulatory authority, the health and family planning authorityand their public staff shall strictly perform their administrative power of punishment based on the nature and details of the illegal conducts in accordance with the types and ranges of the punishments prescribed in this regulation. Detailed rules shall be formulated by the food and drug regulatory authority, the health and family planning authority according to their own duties.

Article 74 In case of violating the provisions of this regulations, the food and drug regulatory authority of the government at county level and above or other relevant authority fails to fulfill the responsibility for the supervision and management of medical devices or abuse power, neglect of duty, fraudulent practice, punishment shall be imposed by supervisory authority or the authority in charge of appointment or removal on the competent person in direct charge and other directly responsible persons; in case serious consequences are caused, a punishment of dismissal or discharge will be imposed.

Article 75 In case of violating the provisions of this regulation and constituting crime, the criminal responsibility shall be investigated according to law; in case of causing personal, property or other damages, the responsibility for compensation shall be borne according to law.

 

Chapter VIII  Supplementary Provisions

 

Article 76 The terms referred in this regulation shall be defined as following:

“Medical devices” is instrument, equipment, appliance, in vitro diagnostic reagent and its calibrator, material, and other similar or relevant articles including necessary computer software, directly or indirectly contacting human body; the effectiveness are obtained mainly through physical means other than pharmacological, immunological or metabolic ways, or such ways are involved in but only play auxiliary roles; which is used to achieve the following intended outcomes:

(I) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

(II) Diagnosis, monitoring, treatment, alleviation or functional compensation for an injury;

(III) Examination, substitution, regulation or support of physiological structure or physiological process;

(IV) Life support or life sustaining;

(V) Contraception Control;

(VI) Examination of the sample from human body to provide information for medical or diagnostic purpose.

Medical device consumption units refer to the institution that provide healthcare services including medical service to others with medical devices, including the medical institution obtained the License for Practice, service institution for family planning obtained the License for Family Planning Practicing, and the blood station, sole plasma collection station, rehabilitation aid assembling institution, etc. which do not need to obtain the License for Practicing according to law.

Large medical equipment refers to the large medical devices based on complex technology, requiring large investment, high operating cost, huge impact on the medical fee and shall be incorporated into the catalogue management.

Article 77 Registration of medical device can be chargeable. Specific charging items and related standards shall be formulated according to relevant national provisions by the pricing and financing authorities under the State Council.

Article 78 The management measures for non-profit contraception medical devices and the management measures for medical devices developed by healthcare institutes in responding to public emergency shall be formulated by the food and drug regulatory authority under the State Council together with the competent health and family planning authority under the State Council.

The management measures for the medical devices of traditional Chinese medicine shall be formulated by the food and drug regulatory authority under the State Council together with the traditional Chinese medicine management authority under the State Council according to the provisions of this regulation; the scope and management measures for rehabilitation aid instrument of medical devices shall be formulated by the food and drug regulatory authority under the State Council together with the civil affairs authority under the State Council according to this regulation.

Article 79 The specific methods for the supervision and management on military used medical devices shall be formulated by the health administrative department of the Chinese people's liberation army according to the provisions of this regulation and related requirements of PLA.

Article 80 This regulation shall come into force from June 1, 2014.

 

 

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