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State Administration for Market Regulation Decree No. 47

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State Administration for Market RegulationDecree No 47Administrative Measures for the Registration and Filing of Medical DevicesCHAPTER 1 GeneralArticle 1The Measures is esta

State Administration for Market Regulation

 

Decree No. 47 


Administrative Measures for the Registration and Filing of Medical Devices

CHAPTER 1 General

Article 1 The Measures is established in accordance with the Regulations on the Supervision and Administration of Medical Devices, aiming to regulate the registration and filing of medical devices and ensure their safety, effectiveness and controllable quality of medical devices.

Article 2 These Measures shall apply to the registration, filing and supervision and administration of medical devices within the territory of the people's Republic of China.

Article 3 Medical device registration is the process of medical device registration applicant (hereinafter referred to as the "Applicant") submitting an application for medical device registration according to legal procedures and requirements, and the drug supervision and administration department conducting evaluation on their safety, effectiveness and quality controllability etc. based on scientific cognition in accordance with laws and regulations, then deciding if the application can be allowed.

Medical device filing is the process of medical device filing applicants (hereinafter referred to as "filing applicants") submitting filing materials to the drug supervision and administration department in accordance with legal procedures and requirements, and the drug supervision and administration department filing the submitted filing materials for future reference.

Article 4 The National Medical Products Administration (NMPA) shall take charge of the national medical device registration and filling management, establish the medical device registration and filling management system, organize the review and approval of the domestic Class III and imported Class II and Class III medical devices, filing of the imported Class I medical devices, as well as related supervision and management work according to law; supervise and guide the registration and filing of local medical devices.

Article 5 The Center for Medical Device Evaluation of NMPA (hereinafter referred to as CMDE) is responsible for the clinical trial application of medical devices requiring clinical trial approval, and other technical review such as the application for registration, change of registration, renewal of registration of domestic Class III and imported Class II and Class III medical devices.

The Center for Medical Device Standardization Administration of NMPA , National Institutes for Food and Drug Control, Center for Food and Drug Inspection of NMPA (hereinafter referred to as Inspection Center), Center for Drug Re-evaluation of NMPA, Administrative Affairs Acceptance Service and Complaint Reporting Center of NMPA, Information Center of NMPA and other professional and technical institutions undertake the management, classification, definition, inspection, verification, monitoring and evaluation, certification preparation and delivery of medical device standards required for the implementation of medical device supervision and management as well as corresponding information construction, management and related work.

Article 6 Drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the registration of the following medical devices within their respective administrative areas:

(I) Review and approval of the registration of domestic class II medical device;

(II) Verification of the quality management systems of domestic class II and class III medical devices;

(III) Organization of the supervision and administration of medical device clinical trial institutions and clinical trials according to law;

(IV) Supervision and guidance on the filing of domestic class I medical devices by the departments responsible for drug supervision and administration at the municipal level divided into districts.

The professional technical institutions for medical devices set or designated by the drug supervision and administration departments at the province level, autonomous regions and municipality level directly under the Central Government shall take charge of the technical review, inspection, validation, monitoring and evaluation required for the implementation of medical device supervision and administration according to law.

The Department in charge of drug supervision and administration at the municipal level divided into districts shall be responsible for the filing management of domestic class I medical devices.

Article 7 The registration and filing management of medical devices shall follow the principles of legality, science, openness, fairness and impartiality.

Article 8 Class I medical devices shall be subject to product filing management. Class II and Class III medical devices shall be subject to product registration management.

The domestic Class I medical devices shall be filed, and the filing applicant shall submit the filing materials to the municipal drug supervision and administration department consisting of districts.

The domestic Class II medical devices shall be reviewed by the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government, and the Medical Device Registration Certificate shall be issued after approval.

The domestic Class III medical devices shall be reviewed and approved by the NMPA, and then a Medical Device Registration Certificate shall be issued.

The imported Class I medical devices shall be filed, the filing applicants shall submit the filing materials to the National Medical Products Administration.

The imported Class II and Class III medical devices shall be reviewed and approved by the NMPA, and then a Medical Device Registration Certificate shall be issued.

Article 9 It is emphasized that the registrants and filing applicants of medical devices should strengthen the whole life cycle management of medical devices, and take responsibility for the safety, effectiveness and quality controllability of medical devices in the whole process of development, manufacturing, operation and use according to law.

Article 10 The NMPA shall give priority to the review and approval of clinically urgent-needed medical devices, implement special review and approval for innovative medical devices, encourage the research and innovation of medical devices, and promote the high-quality development of medical device industry.

Article 11 The NMPA shall establish and improve systems such as medical device standards and technical guidelines in accordance with the law, standardize medical device technical review and approval as well as quality management system verification, and guide and serve medical device R&D and registration applications.

Article 12 The drug supervision and administration department shall timely disclose the relevant information of medical device registration and filing according to law. The applicant can query the approval progress and results, and the public can consult the approval results.

Without the consent of the applicant, the drug supervision and administration department, professional and technical institutions and their staff, experts participating in the review and other personnel shall not disclose the trade secrets, undisclosed information or confidential business information submitted by the applicant or the filing applicant, except as otherwise specified by law or involving national security and major social and public interests.

CHAPTER 2 Basic Requirements

Article 13 Medical device registration and filing shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guidelines to prove that the registered and filing medical devices are safe, effective, and controllable in quality, and ensure that the information in the whole process is true, accurate, complete and traceable.

Article 14 Applicants and filing registrants shall be enterprises or research institutions that can bear corresponding legal responsibilities.

Overseas applicants and filing applicants shall designate enterprise legal persons in China as agents to handle the registration and filing of relevant medical devices. The agent shall assist the registrants and filing applicants to fulfill the obligations specified in paragraph 1 of Article 20 of the Regulations on the Supervision and Administration of Medical Devices, and assist the overseas registrants and filing applicants to implement the corresponding legal responsibilities.

Article 15 The applicants and filing applicants shall establish a quality management systems suitable for the product and maintain its effective operation.

Article 16 The personnel handling registration and filing matters of medical devices shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and related regulations of registration management of medical device registration and filing administration.

Article 17 When applying for registration or filing, the applicant or filing registrant shall submit relevant materials in accordance with the requirements for registration and filing of the NMPA, and shall be responsible for the authenticity of the materials.

The registration and filing materials shall be in Chinese language. Source text shall also be provided for translations from foreign language materials. For references of unpublished literatures, proof of permission by copyright owner of the literatures shall be provided.

Article 18 When applying for registration of imported medical devices and filing imported medical devices, it shall submit the certification documents that the competent authorities of the country (region) where the applicants and the filer are registered or where the production address is located allow the medical devices to be marketed and sold.

If the country (region) where the registered place or production address of the overseas applicant does not manage this product as medical device, the applicants and filing applicants need to provide relevant certificates, including certificates issued by the said country (region) permitting the marketing of this product.

For innovative medical devices that are not marketed in the country (region) where the applicants or the filing applicants is registered or where the place of production is located, relevant documents need not be submitted.

Article 19 Medical devices shall comply with applicable mandatory standards. If the structural features, intended uses and usage methods of the products are inconsistent with the applicable scope of mandatory standards, the applicants and filing registrants shall explain that the mandatory standards are not applicable, and provide relevant materials.

If there are no mandatory standards, the applicants and filing applicants are encouraged to adopt recommended standards.

Article 20 The registration and filing of medical devices shall comply with the relevant requirements of the classification rules and classification catalogue of medical devices.

Article 21 The drug supervision and administration departments shall continuously promote the reform of the review and approval system, strengthen scientific research on medical device supervision and administration, establish a medical device registration management system led by technical review and supported by verification, inspection, monitoring and evaluation, optimize the review and approval process, improve the ability, quality and efficiency of review and approval of medical devices.

Article 22 The professional and technical institutions of medical devices shall establish and improve the communication system, clarify the form and content of communication, and organize communication with the applicant according to work needs.

Article 23 Professional technical institutions of medical devices shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification and inspection, and give full play to the technical support role of experts.

CHAPTER 3 Medical Devices Registration

Section I Product research and development

Article 24 The research and development of medical devices should follow the risk management principles and consider the existing recognized technical level, so as to ensure that all known and foreseeable risks and unexpected impacts of products are minimized and acceptable, and ensure that the benefits of products outweigh the risks in normal use.

Article 25 The engagement in the research and development of medical device products shall conform to the requirements of relevant laws, regulations and mandatory standards in China.

Article 26 The applicant or filing applicant shall prepare the product technical requirements for medical device to be registered or filed.

The product technical requirements mainly include the functional and safety indicators and testing methods that can be objectively judged for the finished medical devices.

Medical devices shall meet the technical requirements of registered or filed products.

Article 27 The applicants and filing applicants shall prepare the product instructions and labels of the medical devices applying for registration or filing.

The product instructions and labels shall comply with the requirements of Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant provisions.

Article 28 In the research and development of medical devices, non-clinical study on medical devices shall be carried out according to the scope of application and technical characteristics of the products.

Non-clinical study includes product chemical and physical performance study, electrical safety study, radiation safety study, software study, biological characteristics study, biosource material safety study, disinfection and sterilization process study, animal test study, stability study, etc..

When applying for registration or filing, the non-clinical evidence generated in the research and development activities shall be submitted, including the overview of non-clinical study reports, study protocols and study reports.

Article 29 The performance and safety indicators and methods determined during the non-clinical study of medical devices shall be compatible with the intended use conditions and purposes of the products, and the study samples shall be representative and typical. If necessary, methodological verification and statistical analysis shall be carried out.

Article 30 When applying for registration or filing, inspection shall be carried out in accordance with the technical requirements of the product and an inspection report shall be submitted. Only those who pass the inspection can conduct clinical trials or apply for registration and filing.

Article 31 The products for inspection shall be able to represent the safety and effectiveness of the products applied for registration or filing, and their production shall meet the relevant requirements of the production quality management specifications of medical devices.

Article 32 The inspection report of medical device products submitted for registration or filing may be the self-inspection report issued by the applicants and filing applicants or the inspection report issued by a qualified medical device inspection agency.

Section II Clinical evaluation

Article 33 In addition to the circumstances specified in Article 34 of the Measures, clinical evaluation shall be conducted for the registration and filing of medical devices.

Clinical evaluation of medical devices refers to the activity of analyzing and evaluating clinical data by scientific and reasonable methods to confirm the safety and effectiveness of medical devices within their scope of application.

When applying for medical device registration, clinical evaluation data shall be submitted.

Article 34 Under any of the following circumstances, clinical evaluation may be exempted:

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

(II) Other circumstances that can prove the safety and effectiveness of the medical device through non-clinical evaluation.

For medical devices exempted from clinical evaluation, clinical evaluation data can be exempted from submission.

The catalogue of medical devices exempted from clinical evaluation shall be formulated, adjusted and published by the NMPA.

Article 35 The clinical evaluation of medical devices can be conducted on the basis of product characteristics, clinical risks and available clinical data. The safety and effectiveness of medical devices can be proved by conducting clinical trials, or by analyzing and evaluating clinical literature and clinical data of the predicate devices.

In accordance with the regulations of NMPA, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the products, clinical trials shall be carried out.

The NMPA has formulated guidance for clinical evaluation of medical devices, specifying the requirements for clinical evaluation through the clinical literature and clinical data of predicate devices, the situations in which clinical trials need to be carried out, and the writing requirements for clinical evaluation reports.

Article 36 If the clinical evaluation is conducted through the clinical literature and clinical data of the predicate devices, the clinical evaluation data include the comparison between the registered products and the predicate devices, the analysis and evaluation of the clinical data of medical devices of the same variety, the scientific evidence and evaluation conclusion when there are differences between the registered products and the products of the same variety.

If clinical evaluation is carried out through clinical trials, the clinical evaluation data include clinical trial protocol, opinions of ethics committee, informed consent form, clinical trial report, etc.

Article 37 The clinical trials of medical devices shall be carried out in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with the regulations in accordance with the requirements of the Good Clinical Practice for Medical Devices. Before the commencement of the clinical trial, the clinical trial sponsor shall file the clinical trial project with the drug supervision and administration department at provincial level, autonomous regions and municipality level directly under the Central Government. The production of clinical trial medical devices shall meet the relevant requirements of the Good Manufacturing Practice for Medical Devices.

Article 38 The clinical trial of Class III medical devices with higher risk to human body shall be approved by NMPA before execution.

The review and approval of clinical trials is a process that the NMPA conducts a comprehensive analysis over medical devices to be carried out with a clinical trial according to the application of the applicant, including risk level, clinical trial protocol, analysis report of comparison between clinical benefits and risks, and determines whether to approve the conduct of the clinical trial.

The catalogue of Class III medical devices that need to be reviewed and approved for clinical trials shall be formulated, adjusted and published by the NMPA. Clinical trials of Class III medical devices that need to be reviewed and approved shall be carried out in qualified medical institutions at Grade III Class A level.

Article 39 If review and approval of clinical trials of medical devices are required, the applicants shall submit application dossiers such as overview materials, study materials, clinical materials, product instructions and sample labels according to relevant requirements.

Article 40 The CMDE shall review the accepted clinical trial application. For the clinical trial application, a decision on whether to approve the application or not shall be made within 60 days from the date of acceptance, and the applicant shall be notified through the website of the CMDE. Failure to notify within the time limit shall be deemed as consent.

Article 41 If supplementary materials are required during the review process, the applicant shall be informed once of all the supplements and corrections to be made by the CMDE. The applicant shall provide the supplementary materials for one time according to the requirement of supplement and correction notice within one year. After receiving the supplementary materials, the CMDE shall complete the technical review within the specified time limit.

If the applicant has objections to the content of supplement and correction notice, it may give its opinion in writing to the CMDE, along with rationales and corresponding technical supporting documents.

If the applicant fails to submit supplementary materials within the time limit, the CMDE shall terminate the technical review and make a decision of disapproval.

Article 42 For serious adverse events related to clinical trial medical devices or other serious safety risk information during the clinical trial of medical devices, the clinical trial sponsor shall report to the drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government where the clinical trial institution is located and take risk control measures in accordance with relevant requirements. If no risk control measures are taken, the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures according to law.

Article 43 In case of the occurrence of large-scale serious adverse events in clinical trial of medical devices or other major safety problems, the sponsor shall suspend or terminate the clinical trial of medical devices and report to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the sponsor is located and where the clinical trial institution is located. If it has not been suspended or terminated, the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures according to law.

Article 44 Clinical trial that has been carried out, in case of any of the following circumstances, the NMPA shall order the applicant to terminate the clinical trial of medical devices:

(I) The clinical trial application dossiers are false;

(II) The latest study confirmed the existence of problems in the ethicality and scientificity of previously approved clinical trials;

(III) Other circumstances that should be terminated.

Article 45 Clinical trials of medical devices shall be implemented within 3 years after approval. If no informed consent is signed by the subject within 3 years from the date of approval of the application for clinical trial of medical devices, the license for clinical trial of medical devices will automatically become invalid. If clinical trials are still needed, a new application shall be made.

Article 46 If a medical device used to treat a serious life-threatening disease with no effective treatment means is under clinical trial and may benefit patients after medical observation, it can be used free of charge for other patients with the same condition in the institution where the clinical trial of the medical device is being carried out after ethical review and informed consent, and their safety data can be used for application for medical devices.

Section III Verification of Registration System

Article 47 The applicant shall submit relevant materials related to the quality management system related to product research and development and production when applying for registration. If the drug supervision and administration department that accepts the application for registration considers it is necessary to verify the quality management system during the product technical review, it shall organize the quality management system verification and access the original data when necessary.

Article 48 The verification of the quality management system of domestic Class III medical device is carried out by the drug supervision and administration department in the province, autonomous region, or municipality directly under the Central Government where the applicant is located after notified by the CMDE.

The verification of the quality management system of domestic Class II medical device is carried out by the drug supervision and administration department in the province, autonomous region, or municipality directly under the Central Government where the applicant is located.

Article 49 The drug supervision and administration department of provinces, autonomous regions and municipalities directly under the Central Government shall carry out quality management systems verification in accordance with the requirements of the Good Manufacturing Practice for Medical Devices, focusing on whether the applicant has established a quality management system suitable for the product in accordance with the requirements of the Good Manufacturing Practice for Medical Devices, and the design and development, production management and quality control related to product research and development and production.

During the process of verification, the authenticity of products for inspection and clinical trial products shall also be verified at the same time, focusing on checking the relevant records of the development process, as well as the relevant records of the production process of inspection products and clinical trial products.

Where a self-inspection report is submitted, key verification shall be carried out on the inspection capability and inspection results of the applicants and filing registrants or the entrusted institution in the process of research and development.

Article 50 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may carry out quality management systems verification by means of data review or on-site inspection. According to the specific situation of the applicant, the supervision and inspection situation, and the comparison results between the products applied for registration this time and the products that have passed verification on the production conditions and processes, determining whether site inspection and inspection contents shall be carried out, so as to avoid repeated inspection.

Article 51 When conducting technical review on imported class II and class III medical devices, if the CMDE considers it is necessary to verify the quality management systems, it shall notify the Audit and Inspection Center of the NMPA to carry out verification according to relevant requirements.

SECTION 4 Product Registration

Article 52 After completing the research on the safety and effectiveness of medical devices supporting the registration, and making preparations for the verification by the quality management system, the applicant shall apply for the medical device registration, and submit the following application dossiers to the drug supervision and administration department through online registration and other application paths according to relevant requirements:

(I) Data for product risk analysis;

(II) Technical requirements for products;

(III) Product inspection report;

(IV) Clinical evaluation data;

(V) Product instructions and sample labels;

(VI) Quality management system documents related to product research and development and production;

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

Article 53 The drug supervision and administration department shall conduct review on application dossiers after accepting an application, and handle respectively according to the following circumstances:

(I) The application items are within the scope of the administrative authority with complete application dossiers and in conformity with the formal review, the application shall be accepted;

(II) If there are errors in the application dossiers that can be corrected on the spot, the applicant is allowed to make rectification on the spot;

(III) If the application dossiers are incomplete or do not comply with the legal form, the applicant shall be informed of all contents to be supplemented or corrected in one time on site or within 5 working days; if failing to inform the applicant within the specified time, the application materials shall be accepted from the receipt date;

(IV) If the application items don't fail within the scope of the administrative authority, the decision of not to accept the application shall be made immediately, and the applicant shall be notified to apply to the relevant administrative authority.

For acceptance or rejection of an application for medical device registration, the drug supervision and administration department shall issue a notice of acceptance or rejection with the special seal of the department and dated.

If the applicant needs to pay fees after the acceptance of the application for medical device registration, the applicant shall pay the fees in accordance with the provisions. If the applicant fails to pay the fee within the specified time limit, it shall be deemed that the applicant voluntarily withdraws the application, and the drug supervision and administration department shall terminate its registration procedure.

Article 54 If supplementary documents are required during technical review, the technical review institution shall notify all the contents that need to be supplemented and corrected at one time. The applicant shall, within one year after receiving the supplement and correction notice, provide supplementary materials once in accordance with the requirements of the notice of correction, and the technical review institution shall complete the technical review within the prescribed time limit after receiving the supplementary materials.

If the applicant has objections to the content of supplement and correction notice, it may give its opinion in writing to the corresponding technical review institution, along with rationales and corresponding technical supporting data.

If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated, and the drug supervision and administration department shall make a decision of not registering.

Article 55 For an accepted registration application, the applicant may, before making the decision on administrative license, apply to the drug supervision and administration department that accepted the application for withdrawal of the registration application and relevant materials, and explain the reasons. If it agrees to withdraw the application, the drug supervision and administration department shall terminate its registration procedure.

If any illegal act such as concealing the true situation or providing false information is found in the process of review, verification and approval, it shall be handled according to law, and the applicant shall not withdraw the application for registration of medical devices.

Article 56 For an accepted registration application, if there is evidence that the registration application dossiers may be false, the drug supervision and administration department may suspend the review and approval. It will be decided whether it shall be further reviewed or the registration application shall be denied after verification.

Article 57 During the review of medical device registration application, if the review conclusion is not passed, the technical review institution shall inform the applicant of the reasons for the failure, and the applicant may raise an objection to the technical review institution within 15 days, and the content of the objection is limited to the original application items and the original application dossiers. The technical review institution shall conduct comprehensive evaluation and feedback to the applicant based on the applicant's objections. The objection processing time is not included in the review time limit.

Article 58 The drug supervision and administration department accepting the registration application shall make a decision on whether to approve it after the technical review is completed. Medical devices meeting the requirements of safety, effectiveness and controllable in quality shall be approved for registration and issued with Medical Device Registration Certificate, and the approved product technical requirements will be distributed to the applicant in the form of attachment. For the products that are not approved for registration, the reasons shall be given in writing, and the applicant shall be informed of its right of applying for administrative reconsideration or appealing to administrative proceeding by law.

The validity period of the Registration Certificate for Medical Device is five years.

Article 59 For accepted registration application, in case of any of the following circumstances, the drug supervision and administration department shall make a decision not to register and inform the applicant:

(I) The applicant's study on the safety, effectiveness and quality controllability of the medical devices to be marketed and the results cannot prove that the products are safe, effective and controllable in quality;

(II) The quality management systems fail to pass the verification, and the applicant refuses to accept the on-site inspection of the quality management systems;

(III) The registration application dossiers are false;

(IV) The contents of the registration application dossiers are confusing, contradictory, or obviously inconsistent with the application items, and the product can not be proved to be safe, effective and controllable in quality;

(V) Other circumstances under which the registration application shall not be approved.

Article 60 The drug supervision and administration department shall announce to the public and hold a hearing on the matters that shall be heard for the implementation of administrative license according to laws, regulations and rules, or other major administrative license matters involving public interests that the drug supervision and administration department deems necessary. If the application for medical devices registration directly involves a significant interest relationship between the applicant and others, the drug supervision and administration department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative license decision.

Article 61 For urgently-needed medical devices for treatment of rare diseases, diseases which are seriously life-threatening and have no effective treatment means, and those used for coping with public health emergencies, the drug supervision and administration department may make a conditional approval decision, specify the validity period, the study work that needs to be completed after marketing, the completion time limit and other related matters in the Medical Device Registration Certificate.

Article 62 For conditionally approved medical devices, the registrant shall collect the data related to the benefits and risks of the medical devices after marketing, continuously monitor and evaluate the benefits and risks of the products, take effective measures to actively control risks, and complete relevant studies within the prescribed time limit as required.

Article 63 For conditionally approved medical devices, if the registrant fails to complete the studies or cannot prove that the benefits outweigh the risks, the registrant shall timely apply for the cancellation of the Medical Device Registration Certificate, and the drug supervision and administration department may cancel the Medical Device Registration Certificate according to law.

Article 64 For medical devices newly researched and developed that not listed in the classification catalogue, the applicant can directly apply for Class III medical device registration or determine the device classification according to the classification principles and apply for classification validation to NMPA so as to apply for product registration or conduct filing for the product.

For medical devices that application is made directly for the registration of Class III medical devices, the NMPA shall determine their classification in accordance with the risk level. For the domestic medical devices identified as Class II or Class I, the applicant shall be informed to apply for registration or file with the corresponding drug supervision and administration department.

Article 65 For registered medical devices of which the management category is adjusted from high class to low class, the medical devices registration certificate shall continue to be valid within the period of validity. If renewal is needed upon expiration of its validity period, application for renewal or filling shall be submitted to the drug supervision and administration department in accordance with the adjusted classification 6 months before the expiration of the validity period of the Medical Device Registration Certificate.

If the medical device management category is adjusted from low to high, the registrant shall apply to the corresponding drug supervision and administration department for registration according to the changed category. The NMPA shall stipulate the time limit for completing the adjustment in the notice of adjustment of the management category.

Article 66 If the Medical Device Registration Certificate is lost, the applicant shall apply for re-issuance to the original certificate issuing authority; the original certificate issuing authority will reissue the Medical Device Registration Certificate after verification.

Article 67 Where a patent dispute arises during the registration review or after approval, it shall be dealt with according to relevant laws and regulations.

CHAPTER 4 Special Registration Procedures

Section I Registration procedures for innovative products

Article 68 For medical devices that meet the following requirements, the applicant may apply for applicable innovative product registration procedures:

(I) The applicant legally owns the patent for invention of core technology of the product through its dominant technical innovation activities in China, or obtains the patent for innovation in China or the right of use through legal transfer; and the time for applying for the registration procedure of innovative products shall be within 5 years from the date of patent authorization announcement; or the application of the patent for invention of the core technology has been made public by the patent administrative authority of the State Council. The Patent Searching and Consulting Center of the China National Intellectual Property Administration shall issue a search report indicating that the core technical scheme of the product has novelty and creativity;

(II) The applicant has completed the preliminary study on the product and the product is basically finalized, the study process is true and controlled, and the study data is complete and traceable;

(III) The main working principle/action mechanism of a product is the first of its kind in China, the product performance or safety has radical improvement compared with similar products, the product is in the international leading level technically, and has significant value in clinical application.

Article 69 When apply for applicable innovative product registration procedures, the applicant shall submit an application for reviewing of innovative medical devices to the NMPA after the product is basically finalized. The NMPA shall organize experts to review, and those that meet the requirements shall be included in the registration procedure of innovative products.

Article 70 For the application of medical devices registration applicable to the registration procedure of innovative products, the NMPA and the institutions undertaking relevant technical work shall appoint special personnel to be responsible according to their respective responsibilities, communicate in time and provide guidance.

For the medical devices included in the registration procedure of innovative products, the CMDE can communicate with the applicant on major technical problems, major safety problems, clinical trial protocol, summary and evaluation of phased clinical trial results in product research and development before the acceptance of registration application and during technical review.

Article 71 If the applicant voluntarily requests to terminate the medical devices included in the innovative product registration procedure, or the NMPA finds that they no longer meet the requirements of the innovative product registration procedure, the NMPA shall terminate the innovative product registration procedure of relevant products and inform the applicant.

Article 72 Medical devices included in the innovative product registration procedure are not applicable to the innovative product registration procedure if the applicant fails to apply for registration within the prescribed time limit.

Section II Priority Registration Procedures

Article 73 Medical devices that meet one of the following conditions may apply for priority registration procedures:

(I) Diagnosis or treatment of rare diseases and malignant tumors with obvious clinical advantages; diagnosis or treatment of unique and multiple diseases of the elderly and there is no effective diagnosis or treatment method at present; used for children with obvious clinical advantages; or there is a clinical urgent-need and there is no medical device approved for registration of the same product in China;

(II) Medical devices that have been listed in the National Science and Technology Major Project or National Key Research and Development Project;

(III) Other medical devices subject to priority registration procedures as stipulated by the NMPA.

Article 74 When applicable to priority registration procedure, the applicant should submit an application for priority registration of medical devices to the drug supervision and administration department when applying for the registration of medical devices. In the case of subparagraph 1 of Article 73, the NMPA shall organize experts to conduct a review. If it meets the requirements, it shall be included in the priority registration procedure; if it falls under sub-paragraph 2 of Article 73, the CMDE shall review it. If it meets the requirements, it shall be included in the priority registration procedure; if it falls under subparagraph 3 of Article 73, the NMPA shall listen to opinions widely and organize experts to demonstrate to determine whether it shall be included in the priority registration procedure.

Article 75 For the medical device registration application included in the priority registration procedure, the NMPA shall give priority to the review and approval, and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall give priority to the verification of the medical device registration quality management systems.

During the technical review of medical device products included in the priority registration procedure, the CMDE shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary.

Section III Emergency Registration Procedures

Article 76 The NMPA may, in accordance with the law, implement emergency registration for medical devices that are required for public health emergencies and have no similar products marketed in China, or that have similar products but whose supply cannot meet the needs for emergency treatment of public health emergencies.

Article 77 When applying for applicable emergency registration procedures, the applicant shall apply to the NMPA for emergency registration and application. Those meeting the conditions shall be included into the emergency registration procedures.

Article 78 The NMPA shall immediately handle the application for registration of medical devices subject to emergency registration in accordance with the requirements of unified command, early intervention, on-call review and scientific review and approval, and carry out medical device product inspection, system verification and technical review in parallel.

CHAPTER 5 Change and Renewal of Registration

Section I Change of Registration

Article 79 The registrant should take the initiative to carry out post-market study on medical devices, and further validate the safety, effectiveness and quality controllability of medical devices, and strengthen the continuous management of marketed medical devices.

In case of any substantial changes of the designs, raw materials, production process, scopes of application or use methods, etc., of the registered medical device products of Class II or Class III, which may affect the safety and effectiveness of such medical devices, registrants shall apply to the original registration departments for change of registration. In case of any other change thereof, they should be filed with the original registration department within 30 days from the date of the change.

Product name, model, specification, structure and composition, scope of application, product technical requirements, and production address of imported medical devices, etc. stated in the registration certificate, are matters specified in the preceding paragraph that need to be registered for change. The name and domicile of the registrant and the name and domicile of the agent belong to the matters that need to be filed as specified in the preceding paragraph. For change of domestic medical device production address, the registrant shall file a record when applying for change corresponding to production license.

In case of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management systems and report to the drug supervision and administration department in accordance with the regulations.

Article 80 For change of registration application, the technical review institution shall focus on the changed part, and evaluate the safety, effectiveness and controllability in quality of the products after change to form a review opinion.

Where the drug supervision and administration department deems that it is necessary to inspect the quality management system during the technical review of the application for change registration, it shall organize an inspection on the quality management system.

Article 81 Medical device registration change document shall be used together with the original Medical Device Registration Certificate, and the expiration date of the validity period is the same as the original Medical Device Registration Certificate.

Section II Renewal of Registration

Article 82 If the Medical Device Registration Certificate is for renewal upon validity period, the applicant shall apply for registration renewal to the original registration department 6 months before the validity period of the Medical Device Registration Certificate, together with the application dossiers in accordance with the relevant requirements.

Except the situation stipulated in Article 83 in the Measures, the drug supervision and administration department, upon receipt the application for registration renewal, shall make decision on registration renewal prior to the validity period of the Medical Device Registration Certificate. If no decision is available after the due time, the renewal application shall be deemed having been approved.

Article 83 The registration renewal shall not be approved in any of the following circumstances:

(I) The applicant fails to apply for registration renewal within the specified time limit;

(II) The new mandatory standards for medical devices have been issued and implemented and the medical devices applying for renewal of application cannot comply with the new requirements;

(III) For the medical device with conditional approval, the items specified in the Medical Device Registration Certificate are not completed within the specified time limit.

Article 84 If the approval time of renewal registration is within the validity period of the original registration certificate, the starting date of the validity period of the renewal registration certificate shall be the next day after the expiration date of the original registration certificate; If the approval time is not within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for renewal registration shall be the date of approval of renewal registration.

Article 85 Where there is no provision in this chapter for the acceptance and approval procedures of the application for change registration application and renewal registration application of medical device, the relevant provisions of Chapter 3 of the Measures shall apply.

CHAPTER 6 Medical Device Filing

Article 86 Filing for Class I medical devices shall be conducted prior to manufacturing.

Article 87 Filing of medical devices, the filing applicant shall submit the filing materials to the drug supervision and administration department in accordance with the Regulations on the Supervision and Administration of Medical Devices and obtain the filing number.

Article 88 For a filed medical device, where the contents set forth in the filing information form and the product technical requirements filed are changed, and the filing applicant shall apply for change of filing information to the original filing authority and submit a description of the changes and related documents. The drug supervision and administration department shall publish the changes in the record information.

Article 89 If the management category of the filed medical devices is adjusted to Class II or Class III medical devices, the filing applicant shall apply for registration in accordance with the relevant provisions of the Measures.

CHAPTER 7 Working Time Limit

Article 90 The time limit stipulated in the Measures is the longest time for the acceptance, technical review, verification and review and approval of medical device registration. The working time limit related to the special registration procedures shall be implemented according to the relevant provisions of the special registration procedures.

The CMDE and other professional technical institutions shall specify and publish their respective working procedures and time limit to the public.

Article 91 After receiving the medical device registration application and clinical trial application, the drug supervision and administration department should put forward the registration application dossiers to the technical review institution within 3 working days after the date of acceptance. The acceptance requirements of clinical trial applications shall apply to the provisions of Article 53 of the Measures.

Article 92 The time limit for technical review of medical device registration shall be implemented in accordance with the following provisions:

(I) The time limit for technical review of medical device clinical trial application is 60 days, and the time limit for technical review after supplementation and correction of application dossiers is 40 days;

(II) The time limit for technical review of class II medical device registration application, change registration application and renewal registration application is 60 days, and the time limit for technical review after supplementation and correction of application dossiers is 60 days;

(III) The technical review time limit for the application for registration of Class III medical devices, change registration application and renewal registration application is 90 days, and the technical review time limit after supplementation and correction of application dossiers is 60 days.

Article 93 The time limit for verification of the quality management systems of Class III medical devices in China shall be implemented in accordance with the following provisions:

(I) The CMDE shall notify the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government to start the verification within 10 days after accepting the application for medical device registration;

(II) The drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government shall, in principle, complete the verification within 30 days after receiving the verification notice, and feed back the verification information, verification results and other related materials to the CMDE.

Article 94 The drug supervision and administration department accepting the application for registration shall make decisions within 20 working days from the dates when the review opinions are received.

Article 95 The drug supervision and administration department shall issue and serve the relevant administrative license documents within 10 days from the date of making the decision on review and approval of medical device registration.

Article 96 If it is necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification, the extended time limit shall not exceed 1/2 of the original time limit. After being approved by the person in charge of relevant technical institutions such as medical device technical review and verification, the technical institution that extended the time limit shall inform the applicant in writing and inform other relevant technical institutions.

Article 97 The original license issuing authority shall reissue the Medical Device Registration Certificate within 20 days after receiving the application for re-issuance.

Article 98 The following time is not included in the relevant working time limit:

(I) The time taken by the applicant for supplementary materials and rectification after verification;

(II) Time for delaying the verification due to the applicant;

(III) The time when external expert consultation is needed, the expert consultation meeting is held, and the drug-device combination products need to be jointly reviewed with the drug review agency;

(IV) If the review and approval procedures are suspended in accordance with regulations, the time taken during the suspension of the review and approval procedures;

(V) The time taken for quality management systems verification.

Article 99 The time limit stipulated in the Measures shall be calculated on working days.

CHAPTER 8 Supervision and administration

Article 100 The drug supervision and administration department shall strengthen the supervision and inspection of the research and development of medical devices, when necessary, conduct extended inspections on the units and individuals that provide products or services for the research and development of medical devices, and the relevant units and individuals shall cooperate with them, provide relevant documents and materials, and shall not refuse, conceal or obstruct.

Article 101 The NMPA shall establish a step-by-step implementation system for the unique device identification (UDI), applicants and filing applicants shall submit UDI related information in accordance with relevant regulations, so as to ensure that the data is true, accurate and traceable.

Article 102 The NMPA shall timely inform the drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government of the agent's information. The drug supervision and administration department of the provinces, autonomous regions or municipalities directly under the Central Government shall organize daily supervision and management of agents in their respective administrative regions.

Article 103 The drug supervision and administration department of the provinces, autonomous regions or municipalities directly under the Central Government shall, according to the filing situation of medical device clinical trial institutions, organize the supervision and inspection of clinical trial institutions that have been filed within their respective administrative regions. For newly filed medical device clinical trial institutions, the first supervision and inspection shall be carried out within 60 days after filing.

The drug supervision and administration departments at provincial level, autonomous regions and municipality level directly under the Central Government shall organize daily supervision and inspection on medical device clinical trial institutions in this administrative region in compliance with Good Clinical Practice for Medical Practice, and supervise them to continuously meet the prescribed requirements. The NMPA shall supervise and inspect the clinical trial institutions of medical devices as required.

Article 104 If the drug supervision and administration department deems it necessary, the authenticity, accuracy, integrity, standardization and traceability of clinical trials can be checked on site.

Article 105 In the post filing supervision, the drug supervision and administration department responsible for the filing of class I medical devices finds that the filing materials are not standardized, it shall order the filing applicants to make corrections within a time limit.

Article 106 If the drug supervision and administration department fails to discover the systemic and regional risks in the registration management of medical devices within its administrative area in time, or fails to eliminate the systemic and regional hidden dangers in the registration management of medical devices within its administrative area in time, the drug supervision and administration department at a higher level may interview the drug supervision and administration department at a lower level.

CHAPTER 9 Legal Liabilities

Article 107 Any institution or individual that violates the provisions under Article 79 and fails to file the changes as required shall be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined RMB 10,000 - 30,000.

Article 108 Those who carry out clinical trials of medical devices without complying with the Good Clinical Practice shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices.

Article 109 Where a technical review institution for medical devices fails to perform its duties in accordance with the Measures, resulting in major errors or serious consequences in the review, the departments in charge of drug supervision and administration shall order it to make corrections, report criticisms and give warnings; where serious consequences are caused, the legal representative, principal responsible person, direct responsible person in charge and other responsible persons of the illegal institution shall be given sanctions according to law.

Article 110 Any staff member of the department in charge of drug supervision and administration who, in violation of regulations, abuses his power, neglects his duty or engages in malpractices for personal gain shall be punished according to law.

CHAPTER 10 Supplementary Provisions

Article 111 In principle, medical device registration or filing units shall be based on the technical principle, structural composition, performance indicator and scope of application of products.

Article 112 The medical devices approved for registration refer to those consistent with the content limited in Registration Certificate for Medical Device and attachments thereof and are manufactured within the validity period of registration certificate for medical device.

Article 113 If the combined parts listed in the column of "Structure and Composition" in the Medical Device Registration Certificate are used for replacement of consumables, after-sales service and maintenance, they can be sold separately.

Article 114 In applying for medical device product registration, change registration and clinical trial approval, the applicant may quote the registered medical device master document with the authorization of the owner of the medical device master document. The work procedures related to the registration of master documents of medical devices shall be stipulated separately.

Article 115 The format of Medical Device Registration Certificate shall be normalized by NMPA uniformly.

Registration numbers shall be arranged in the following form:

×1 XZ ×2××××3×4××5××××6, wherein:

×1 shall mean the abbreviation of the place where the registration review and approval authority is located:

The domestic Class III medical devices and the imported Class II and Class III medical devices are marked as "G.";

The domestic Class II medical devices adopt the abbreviation of the province, autonomous region and municipality directly under the Central Government where the registration review and approval department is located;

×2 shall indicate the form of registration:

The word "Z." is applicable to domestic medical devices;

The word "J." is applicable to imported medical devices;

The word "X." is applicable to medical devices in Hong Kong, Macau and Taiwan Province;

××××3 shall indicate the year of initial registration;

×4 shall the product management category;

××5 shall indicate the product classification code;

××××6 shall indicate the serial number of initial registration.

For the registration renewal, ××××3 and ××××6 shall remain the same. If the management category is adjusted, a new number shall be assigned.

Article 116 The Filing Certificate for Class I Medical Device shall be arranged in the following form:

X1 XB XXXX2XXXX3, wherein:

X1 shall mean the abbreviation of the place where the filing authority is located:

The imported Class I medical devices should be marked as "G.";

The domestic Class I medical devices should be marked with the abbreviation of the province, autonomous region or municipality directly under the Central Government where the filing department is located plus the abbreviation of the municipal administrative region where the district is located (if there is no municipal administrative region with corresponding district, it is only the abbreviation of the province, autonomous region or municipality directly under the Central Government);

XXXX2 shall indicate the year of filing;

XXXX3 shall indicate the serial number of filing.

Article 117 Electronic documents of Medical Device Registration Certificate, change registration document produced by drug supervision and administration department have the same legal effect as paper documents.

Article 118 The NMPA, may, according to work necessity, authorize the drug supervision and administration departments or technical organizations of provinces, autonomous regions and municipalities directly under the Central Government and relevant social organizations to conduct the specific work in accordance with law.

Article 119 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate special registration procedures for class II medical devices within their administrative regions with reference to the provisions of Chapter IV of the Measures, and report them to the NMPA for filing.

Article 120 The items and standards of registration fees for medical device products shall be implemented in accordance with the relevant provisions of the competent department of finance and price under the State Council.

Article 121 The registration and filing of in-vitro diagnosis reagents administered as medical devices are applicable to the Administrative measures for IVD Registration and filing.

Article 122 Relevant provisions on the supervision and administration of customized medical devices shall be separately formulated by the NMPA.

The relevant provisions on the registration administration of drug-device combination products shall be formulated separately by the NMPA.

Relevant provisions on the emergency use of medical devices shall be separately formulated by the NMPA together with relevant departments.

Article 123 The medical devices from Hong Kong, Macao and Taiwan shall be registered and filed by reference to the import medical devices.

Article 124 The Measures shall come into force as of October 1, 2021. The Administrative Measures on Medical Device Registration (Former CFDA Decree No. 4) issued on July 30, 2014 shall be abolished simultaneously.

 

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