Welcome to Beijing Beat IVD MD Technology!  

Add to Favorites | Setup as front page  | 中文 | EN

 
Tel:010-57253929
Home About us Services News Success cases Regulations Exhibitions Contacts US

current location: Home > Regulations > Regulations for the Supervision and Administration of Medical Devices (State Order No.650)

    Regulations

Contact: 010-57253929
18601253261
Website: www.bestivdmd.com
Online QQ:
 
 

Regulations

Regulations for the Supervision and Administration of Medical Devices (State Order No.650)

source:This site   release time: 2018-05-24 11:02:39   Browsing:301次  Font size: [大] [中] [小]
The Regulation hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety Article 2The food and drug re

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

The clinical trial of medical devices shall follow the requirements of Good Clinical Practice for Medical Device and be conducted by the qualified clinical trial institution, and also shall file a record with the food and drug regulatory authority of the government of the province, autonomous region, and municipality directly under the central government where the applicant of clinical trial 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 conditions for identifying qualification of medical device clinical trial institution and the Good Clinical Practice for Clinical Trials shall be formulated 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; medical device clinical trial institution shall be verified 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.

 

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 required upon the expiration of the valid period, the procedures for the license extension shall be followed according to the provisions in relevant administrative laws.

 

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. 

 

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.

 

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.

 

Article 64  

In case that such licenses and certificates as the Registration Certificate for Medical Device, Medical Device Manufacturing License, Medical Device Operating Permit, approval document for advertising, etc. are obtained by providing  spurious  materials or by other deception means, the license or permit already obtained shall be revoked by original issuing authority and a fine above RMB 50,000 but less than RMB 100,000 shall be imposed; the medical device license application from relevant responsible person and/or enterprise shall not be accepted within 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.

 

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 medic

 

Related Links

Home | Success cases | Online message | Link | Contacts US | Privacy Policy

Beijing Best IVD MD Technology Co., Ltd. www.bestivdmd.com
Addr: Room 310B, 310,310A,311,218,No.29 Building.No.61 Fuxing Road, Beijing, (100036) P.R.China, tel:010-57253929 18601253261 email:bestivdmd@bestivdmd.com
Copyright © 2007-2018 , All Rights Reserve Website Construction: soupu.net Website Management