Provisions for Medical Device Registration and Filing
Provisions for Medical Device Registration and Filing
(Promulgated by SAMR Decree No. 47, issued on August 26, 2021 and shall go into effect as of October 1, 2021)
Chapter I General Provisions
Article 1 The Provisions are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices for the purpose of standardizing the acts of registration and filing of medical devices and ensuring safety, effectiveness and quality of medical devices.
Article 2 The Provisions shall apply to the registration and filing of medical devices, and their supervision and administration within the territory of the People's Republic of China.
Article 3 Medical device registration refers to the activity that the registration applicant of medical devices (hereinafter referred to as the "applicant") submits an application for medical device registration in accordance with the legal procedures and relevant requirements, and the drug regulatory department reviews the safety, effectiveness and quality management in accordance with laws and regulations and based on the scientific cognition, to decide whether or not to approve such an application.
Medical device filing refers to the activity that the filing entity of medical devices (hereinafter referred to as the "filing entity") submits the filing materials to the drug regulatory department in accordance with the legal procedures and relevant requirements, and the drug regulatory department files such submitted filing documents for future reference.
Article 4 The National Medical Products Administration (NMPA) shall take charge of the administration of medical device registration and filing nationwide, be responsible for establishing the administration system and institution for medical device registration, organizing the review and approval of domestic Class III and import Class II and Class III medical devices and the filing of import Class I medical devices as well as the supervision and administration thereof according to law, and be responsible for the supervision and guidance of medical device registration and filing conducted by local drug regulatory departments.
Article 5 The Center for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registration application, change registration application and registration renewal application of domestic Class III and imported Class II and Class III medical devices.
The Center for Medical Device Standardization Administration, National Institutes for Food and Drug Control (NIFDC), Center for Food and Drug Inspection (CFDI), Center for Drug Reevaluation (CDR), Center for Administrative Services and Complaints & Reports, Center for Information of NMPA and other technical institutions shall assume the administration of medical device standards, classification and definition, testing, inspection, monitoring and reevaluation, certificate making and delivery, and other work related to information technology construction and management that are necessary for supervision and administration of medical devices according to their responsibilities.
Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall be responsible for administration of the registration of following medical devices within their own administrative areas:
(I) Review and approval of the registration of domestic Class II medical devices;
(II) Inspection of the quality management system of domestic Class II and Class III medical devices;
(III) Supervision and administration of medical device clinical trial institutions and clinical trials according to law;
(IV) Supervision and guidance of the filing of domestic Class I medical devices for the drug regulatory department of the city divided into districts.
Specialized technical institutions for medical devices established or designated by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall undertake the technical evaluation, testing, inspection, monitoring and reevaluation and other tasks required for the supervision and administration of medical devices.
The drug regulatory department of the city divided into districts shall be responsible for filing management of domestic Class I medical devices.
Article 7 The medical device registration and filing management shall follow the principles of legality, scientificity, publicity, fairness, and justice.
Article 8 Class I medical devices are subject to the management of products by way of filing, and Class II and Class III medical devices are subject to the management of products by way of registration.
To apply for filing of class I domestic medical devices, the filing entity shall submit the filing documents to the drug regulatory department of the city divided into districts.
Class II domestic medical devices shall be reviewed by the drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government, and the medical device registration certificate shall be issued after approval.
Class III domestic medical devices shall be reviewed by the NMPA, and the medical device registration certificate shall be issued after approval.
To apply for filing of import class I medical devices, the filing entity shall submit the filing documents to the NMPA.
Import class II and class III medical devices shall be reviewed by NMPA, and the medical device registration certificate shall be issued after approval.
Article 9 The medical device registrant and filing entity shall strengthen the quality management over the whole life cycle of medical devices, and bear responsibilities for the safety, effectiveness, and quality of medical devices in the process of research and development (R&D), manufacturing, distribution, and use according to law.
Article 10 The NMPA shall implement priority review and approval for medical devices in urgent clinical need and special review and approval for innovative medical devices, so as to 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 the systems including medical device standards and technical guidance, standardize the technical evaluation of medical devices and the inspection of quality management system, guide and serve the R&D and registration application of medical devices.
Article 12 The drug regulatory department shall publicize relevant information on medical device registration and filing promptly according to law. The applicant can look up the review and approval progress and relevant results, and the public can look up the results of review and approval.
Without the consent of the applicant, the drug regulatory department, specialized technical institutions and staff members thereof, and experts involved in review shall not disclose business secrets, undisclosed information or confidential business information submitted by the applicant or the filing entity, unless otherwise provided by law, or national security or the material social and public interest is involved.
Chapter II Essential Requirements
Article 13 The registration and filing of medical devices shall comply with relevant laws, regulations, rules and mandatory standards, follow basic principles for the safety and performance of medical devices, and refer to the relevant technical guidance, to prove that the medical devices to be registered or filed are safe, effective and with quality controlled, and to ensure that the information for registration or filing through the whole process is authentic, accurate, complete and traceable.
Article 14 The applicant and filing entity shall be enterprises or R&D institutions capable of assuming corresponding legal liabilities.
The overseas applicant and filing entity shall designate a domestic enterprise legal person to act as the agent and to carry out the registration and filing of medical devices. The agents shall assist registrants and filing entities to fulfill the obligations prescribed in paragraph one, Article 20 of the Regulations on Supervision and Administration of Medical Devices, and assist overseas registrants and filing entities to implement the corresponding legal liabilities.
Article 15 The applicant and filling entity shall establish a quality management system suitable for products, and shall keep its effective operation.
Article 16 The persons undertaking the registration and filing of medical devices shall have corresponding expertise and be familiar with the laws, regulations and rules related to administration of the registration and filing of medical devices and the provisions related to registration management.
Article 17 For registration or filing application, applicants or filing entities shall submit relevant dossiers according to the requirements related to registration or filing of NMPA and be responsible for the authenticity of materials submitted.
The documents for registration application or filing shall be in Chinese. Where they are translated from a foreign language, the original documents shall also be provided at the same time. When referring to unpublished literature, it is required to provide documents proving the owner's permission to use the information.
Article 18 Where applying for the registration or filing of imported medical devices, it is required to submit the marketing certificate issued by the competent authority of the country (region) where the applicant or filing entity is registered or where the manufacturing site is located.
If the product is not managed as medical device in the country (region) where the applicant or filing entity is registered or the manufacture is carried out, the applicant or filing entity shall provide relevant proof documents, including the permission for marketing the product in the country (region) where the applicant or filing entity is registered or the manufacture is carried out.
For any innovative medical device that has not been marketed in the country (region) where the applicant and filing entity is registered or where the manufacturing site is located, relevant documents are not required.
Article 19 Medical devices shall conform to applicable mandatory standards. For any inconsistency in structural characteristics, intended use and method of use between a product and the scope of application of a mandatory standard, the applicant or filing entity shall propose a statement on the non-applicability to the mandatory standard, with relevant documents attached.
In the absence of mandatory standards, applicants or filing entities are encouraged to adopt recommended standards.
Article 20 The registration and filing of medical devices shall follow the classification rules and classification catalogue of medical devices.
Article 21 The drug regulatory departments shall continue to accelerate the reform of review and approval system, strengthen the research on regulatory science for medical device supervision, establish a registration management system for medical devices lead by technical evaluation and supported by inspection, testing, monitoring and reevaluation, optimize the review and approval procedures, enhance the review and approval capacity, and improve the quality and efficiency of review and approval.
Article 22 Specialized technical institutions of medical devices shall establish and improve a communication system, clarify the forms and contents of communication, and organize the communication with applicants as needed.
Article 23 Specialized technical institutions of medical devices shall establish an expert consulting system as needed, through which they may collect advice from experts with regard to major issues in the procedures of review, inspection and testing, etc. and take full advantage of the technical support of experts.
Chapter III Medical Device Registration
Section I Product Research & Development
Article 24 The R&D of medical devices shall follow the risk management principle and take into account the existing commonly recognized technical standards so as to ensure that all known and foreseeable risks and unintended impacts of the products are minimized and acceptable, and that benefits of the products outweigh risks during normal use.
Article 25 For the engagement in R&D activities of medical devices, the requirements of relevant laws, regulations and mandatory standards of China shall be met.
Article 26 The applicant or filing entity shall prepare the product technical requirements for medical device to be registered or filed.
Product technical requirements mainly include the functional and safety indicators and test methods that can be objectively determined for the finished medical devices.
Medical devices shall comply with the product technical requirements which are registered or filed.
Article 27 The applicant or filing entity shall prepare the instructions for use (IFU) and labels for medical device to be registered or filed.
The IFU and labels of product shall conform to the requirements specified in Article 39 of the Regulations on Supervision and Administration of Medical Devices and relevant provisions.
Article 28 For R&D of medical devices, the non-clinical study shall be carried out based on the scope of application and technical characteristics of the products.
The non-clinical study includes chemical and physical property study, electrical safety study, radiation safety study, software study, biological property study, biological material safety study, disinfection and sterilization process study, animal experimental study, and stability study, etc.
In the event of registration or filing application, non-clinical evidences generated in the R&D activities shall be submitted, including the overview, protocol and report of non-clinical studies.
Article 29 The functional and safety indicators and test methods determined in the non-clinical study of medical devices shall be adapted to the intended use conditions and purposes of the product, and the samples shall be representative and typical. When necessary, methodological validation and statistical analysis shall be carried out.
Article 30 In the event of registration or filing application, testing shall be performed in accordance with the product technical requirements, with the test report submitted. Only for those qualified in the test, the clinical trials, registration or filing application can be carried out.
Article 31 The products used in the testing shall represent the safety and effectiveness of the product to be registered or filed, and the production thereof shall conform to relevant requirements of Good Manufacturing Practice (GMP) for Medical Devices.
Article 32 The test report of medical device issued for registration or filing application may be the self-test report of the applicant or filing entity, or the test report issued by a qualified medical device testing institution entrusted thereby.
Section II Clinical Evaluation
Article 33 Except for the circumstances specified in Article 34 of the Provisions, clinical evaluation shall be conducted for the registration and filing of medical devices.
Clinical evaluation of medical device refers to an activity that analyzes and evaluates the clinical data by using scientific and reasonable methods to confirm the safety and effectiveness of the medical device within its scope of application.
When applying for registration of medical device, the clinical evaluation materials shall be submitted.
Article 34 In one of the following circumstances, clinical evaluation may be exempted:
(I) Where the functional mechanism of the device is definite, the design is finalized, the manufacturing process is well-established, the marketed predicate device has been in clinical use for years and no serious adverse events (SAEs) are recorded, and its regular intended use is not changed.
(II) Where the safety and effectiveness of the medical device can be proven through non-clinical evaluation.
For the exemption from clinical evaluation, the submission of clinical evaluation materials can be exempted.
The catalogue of medical devices exempted from clinical evaluation shall be formulated, adjusted and published by NMPA.
Article 35 For the purpose of performing clinical evaluation for a medical device, it is feasible to prove the safety and effectiveness of the medical device by carrying out the clinical trial according to the product characteristics, clinical risks and the existing clinical data or by performing analysis and evaluation on the clinical literature data and/or clinical data of predicate devices.
According to the provisions of NMPA, when conducting clinical evaluation of medical devices, if the existing clinical literature data and clinical data are insufficient to validate the safety and effectiveness of the products, a clinical trial shall be conducted.
The NMPA shall formulate the guidance for clinical evaluation of medical devices to clarify the requirements for clinical evaluation conducted with the clinical literature data and clinical data of the predicate device, the circumstances requiring clinical trials, and the requirements for preparing the clinical evaluation report.
Article 36 For clinical evaluation conducted with the clinical literature data and clinical data of the predicate device, the clinical evaluation materials shall include the comparison between the product under registration application and the predicate device, analysis and evaluation of clinical data of the predicate device, scientific evidence and the evaluation conclusion, etc. submitted for the difference(s) between the product under registration application and the predicate device.
For clinical evaluation conducted through a clinical trial, the clinical evaluation materials shall include the clinical trial protocol, the ethics committee comments, informed consent form (ICF), and the clinical trial report, etc.
Article 37 The clinical trial of medical device shall be conducted according to the requirements of the Good Clinical Practice (GCP) within a qualified clinical trial institution which has been filed as required. Before the clinical trial, the sponsor shall file the clinical trial project to the drug regulatory department of the province, autonomous region and municipality directly under the central government where it is located. The manufacturing of medical device used in the clinical trial shall comply with relevant requirements of the GMP for Medical Devices.
Article 38 Where the clinical trial of a class III medical device poses high risks to human body, it shall be subject to approval by the NMPA.
The review and approval of a clinical trial is a process that NMPA conducts a comprehensive analysis to the degree of risks, clinical trial protocol, comparative analysis report on clinical benefit and risk of the device to be put on clinical trial may entail, to determine whether to approve the clinical trial.
The catalogue of class III medical devices subject to clinical trial approval shall be compiled, adjusted and published by the NMPA. The clinical trials of Class III medical devices requiring review and approval shall be conducted within qualified tertiary A medical institutions.
Article 39 For medical device clinical trials requiring review and approval, applicants shall submit the application materials such as overview, research data, clinical documents, product IFU and label sample according to relevant requirements.
Article 40 The CMDE shall evaluate the clinical trial applications accepted. A decision on whether to approve the clinical trial application shall be made within 60 days from the date of acceptance thereof, and be notified to the applicant through the website of CMDE. Failure to notify within the time limit shall be deemed as approval.
Article 41 Where supplementary materials are required during evaluation, the CMDE shall inform the applicant in one notification of all the required supplementary materials. The applicant shall submit all the required supplementary materials within 1 year in a single delivery as requested by the notification. Upon the receipt of supplementary materials, CMDE shall complete the technical evaluation within the specified time limit.
Where the applicant has an objection to any supplementary content as requested by the notification, it may submit its written opinions to CMDE to explain reasons and provide corresponding technical supporting materials.
Where the applicant fails to submit the required supplementary materials within the specified time limit, the CMDE shall terminate the technical evaluation, and reject the registration application.
Article 42 For the information of SAEs related to medical devices or other serious safety risks occurring during clinical trials of medical devices, the sponsors of clinical trials shall report to the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government where they are located and where the clinical trial institutions are located, respectively in accordance with relevant requirements, and moreover, risk control measures shall be taken. Where risk control measures are not taken, drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall order the sponsors to take corresponding risk control measures according to law.
Article 43 In the event of large-scale SAEs related to medical devices or other major safety issues in the clinical trials of medical devices, the sponsors shall suspend or terminate medical device clinical trials and report to the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government where they are located and where the clinical trial institutions are located, respectively. Where the medical device clinical trials are not suspended or terminated, drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall order the sponsors to take corresponding risk control measures according to law.
Article 44 In any of the following circumstances, the NMPA may order the applicant to terminate the approved clinical trial of medical device that has already been carried out:
(I) The clinical trial application materials are spurious;
(II) The latest research confirms that an already approved clinical trial has existing problems in ethicality and scientificity;
(III) Other circumstances where the clinical trial shall be terminated.
Article 45 Clinical trials of medical devices shall be carried out within 3 years upon approval; where no subject signs the ICF within 3 years from the date of approval of a medical device clinical trial, the approval of the clinical trial shall expire spontaneously. Where a clinical trial is still required, an application shall be re-submitted.
Article 46 For medical devices under clinical trials, which are intended for treating diseases that severely endanger life and have not been effectively treated yet, and are deemed to benefit the patient through medical observations, they may be used for free on other patients with similar diseases in the institution carrying out the medical device clinical trial after ethical review and obtaining the informed consent, and the safety data may be used for medical device registration application.
Section III Registration System Verification
Article 47 The applicant shall submit quality management system materials related to product R&D or manufacturing at the time of registration application. Where a drug regulatory department accepting the registration application deems it necessary to conduct inspection on the quality management system at the time of technical evaluation of the product, the drug regulatory department shall organize the inspection on the quality management system and may access the original data as needed.
Article 48 In case of the inspection on quality management system of domestic Class III medical devices, the CMDE shall inform the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government where the applicants are located to carry out the inspection.
In case of the inspection on quality management system of domestic Class II medical devices, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government where the applicants are located shall organize to carry out the inspection.
Article 49 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall conduct the inspection on quality management system in accordance with the GMP for Medical Devices, focusing on whether the applicant has established the quality management system adapted to the product in accordance with the GMP, and also on the contents related to product R&D and production such as the design and development, production management and quality control.
In the process of inspection, the authenticity of products used in the testing and clinical trial shall be checked at the same time. The focus shall be centered on consulting the relevant records on the process of design and development, as well as the relevant records on the manufacturing of such products.
Where a self-test report is submitted, the inspection will focus on the test qualification of the applicant, filing entity or entrusted institution during the development as well as the test results.
Article 50 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government may carry out quality management system inspection by means of data evaluation or on-site inspection. The determination on whether to carry out an on-site inspection or not as well as the inspection contents shall be made according to specific situation of the applicant, information about supervisory inspection, as well as the comparison in terms of manufacturing conditions and processes between the product under registration application and that passing the previous review, so as to avoid repeated inspection.
Article 51 Where the CMDE deems it necessary to conduct inspection on the quality management system for imported Class II or Class III medical devices at the time of technical evaluation, it shall notify the CFDI to carry out the inspection according to relevant requirements.
Section IV Product Registration
Article 52 After completing the safety and effectiveness study supporting medical device registration and being ready for accepting the inspection on the quality management system, the applicant can submit an application for medical device registration and submit the following registration dossiers to the drug regulatory department through online registration application:
(I) Product risk analysis data;
(II) Product technical requirements;
(III) Test report of the product;
(IV) Clinical evaluation materials;
(V) Product IFU and label sample;
(VI) Documents of quality management system related to product development and manufacturing;
(VII) Other materials necessary for demonstrating the safety and effectiveness of products.
Article 53 The drug regulatory department shall conduct review after receiving a registration application, and handle respectively according to the following circumstances:
(I) Where the application is within the scope of functions and duties of the administrative authority, and the registration dossier are complete and meet the formal review requirements, the application shall be accepted;
(II) Where the registration dossier have errors that may be corrected on the spot, the applicant shall be allowed to correct them on the spot.
(III) Where the registration dossier are incomplete or do not meet the requirements for the statutory format, the applicants shall be informed one-off of all the supplements or corrections required on the spot or within 5 workdays. If failing to inform the registrant within the specified time limit, the registration dossier is regarded as accepted from the receipt date;
(IV) Where the application item is not within the scope of functions and duties of the administrative authority, the decision of rejection shall be made immediately and the applicant shall be informed to apply to the relevant administrative authority.
The drug regulatory department shall grant a dated acceptance or rejection notice affixed with its special seal to indicate its acceptance or rejection of the medical device registration application.
Once the medical device registration application is accepted, the applicant shall make payment if needed according to the regulations. Where the applicant fails to make payment within the specified time limit, the applicant will be deemed to voluntarily withdraw the application, and the drug regulatory department shall terminate the registration procedure.
Article 54 Where supplementary and corrective materials are required during technical evaluation, the technical evaluation institution shall inform the applicant one-off of all the supplements and corrections to be completed. The applicant shall provide required supplementary materials in a single delivery within 1 year upon receipt of the notification, and the technical evaluation institution shall, within the specified time limit, complete the technical evaluation upon receipt of required supplementary materials.
Where the applicant has an objection to the content of the notification, it may submit its written opinions to the corresponding technical evaluation institution, to explain its reasons and provide corresponding technical supporting materials.
Where the applicant fails to submit the required supplementary materials within the specified time limit, technical evaluation shall be terminated, and the drug regulatory department will reject the registration application.
Article 55 For an accepted registration application, the applicant may, prior to the administrative permission decision is made, withdraw the registration application and relevant materials, and give reasons to the drug regulatory department which accepted the application. Where the withdrawal of the application is approved, the drug regulatory department shall terminate the registration procedure.
If the evaluation, inspection or approval is suspected of any circumstance under which the real situation is concealed or false information is provided or other illegal acts emerge, it shall be handled in accordance with laws, and the applicant shall not withdraw the registration application for medical device.
Article 56 For an accepted registration application, where there are evidences indicating that the registration dossiers may be spurious, the drug regulatory department shall suspend the review and approval process. After investigation, the drug regulatory department shall determine to continue the process or to reject the registration application in accordance with the investigation conclusion.
Article 57 During the evaluation of medical device registration application, for those to be rejected, the technical evaluation institution shall inform the applicant of the reasons for rejection, and the applicant can raise objection to the technical evaluation institution within 15 days with the contents concerned only limited to the original application items and original application materials. The technical evaluation institution shall conduct a comprehensive evaluation taking the objection of the applicant into consideration and give feedback to the applicant. The time taken for handling the objection shall not be counted into the time limit for the evaluation.
Article 58 The drug regulatory department accepting the registration application shall make the decision of whether to approve or not upon the conclusion of technical evaluation. For that meeting safety, effectiveness and quality requirements, the registration shall be approved, and a medical device registration certificate shall be issued, and the approved product technical requirements shall be issued as an attachment to the applicant. For that disapproved, reasons shall be given in writing, and the applicant shall be informed of its right to apply for an administrative reconsideration or administrative litigation in accordance with laws and regulations.
The period of validity of the medical device registration certificate is five years.
Article 59 For accepted registration applications, where one of the following circumstances exists, the drug regulatory department shall decide to reject the application and notify the applicant:
(I) The research conducted by the applicant and its result cannot prove the safety, effectiveness and quality of the medical device to be sold on the market.
(II) Where the quality management system inspection is failed, and the applicant refuses to accept on-site inspection on the quality management system;
(III) The registration dossiers are spurious.
(IV) Where the registration application dossiers contain confused or contradictory contents, or those obviously inconsistent with the application items, which cannot prove the safety, effectiveness and quality of the product;
(V) Other circumstances under which the registration application shall not be approved.
Article 60 For the item of implementing administrative licensing that shall be subject to hearing as specified in the laws, regulations and rules, or other major administrative licensing items involving public interests that need to hold a hearing as deemed by medical products administration, the drug regulatory department shall announce to the public and hold a hearing. For medical device registration applications that have a direct bearing on the vital interests between the applicant and the other party, the drug regulatory departments shall, prior to making the decision of administrative licensing, inform the applicant and the interested party of their rights of requesting for hearing.
Article 61 The drug regulatory departments may conditionally approve the registration of medical devices for treating rare diseases and diseases that severely endanger life and have not been effectively treated, and those under urgent need for dealing with public health emergencies, and shall specify such relevant matters as validity period, post-marketing research to be completed and the completion time limit, etc. in the medical device registration certificate.
Article 62 For a medical device with conditional approval, the registrant shall collect the data on benefits and risks after the medical device marketing and continuously monitor and evaluate the benefits and risks of the product, take effective measures to actively manage and control risks, and complete the research and submit relevant materials as required within the specified time limit.
Article 63 For a medical device with conditional approval, if the registrant fails to complete the study as required within the time limit or fails to prove that its benefits outweigh the risks, the registrant shall apply for the cancellation of the medical device registration certificate in a timely manner and the drug regulatory department may cancel the medical device registration certificate according to law.
Article 64 For a newly developed medical device not yet listed in the classification catalogue, the applicant may directly apply for a Class III medical device registration, or may determine the classification of the product according to the classification rules and apply to the NMPA for a class confirmation, and apply for product registration or for filing thereafter.
Where a Class III medical device registration is directly applied for, the NMPA shall determine the class according to its risk degree. Where a domestic medical device is determined as a Class II or Class I product, the applicant shall be informed to apply for registration or conduct filing at the corresponding drug regulatory department.
Article 65 Where, for a registered medical device, the management classification is adjusted from a higher class to a lower one, the registration certificate within its period of validity shall remain valid. Where a renewal is needed, the registrant shall apply for registration renewal or filing on the changed classification to corresponding drug regulatory department six months prior to the expiration of period of validity of the registration certificate.
Where, the classification management is adjusted from a lower class to a higher one, the registrant shall apply for registration on the changed classification to the corresponding drug regulatory department. The NMPA shall specify a time limit for completing the adjustment in the notice on adjusting management classification.
Article 66 In case of the loss or damage of medical device registration certificate and attachments thereto, the registrant shall submit an application for certificate re-issuance to the original issuing authority. The original issuing authority shall re-issue the certificate upon review.
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 IV Special Registration Procedures
Section I Registration Procedures for Innovative Products
Article 68 For medical devices that comply with the following requirements, the applicant may apply for the applicability to procedures for the registration of innovative products:
(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 invention in China or the right of use through legal transfer; and the date to apply for the applicability to procedures for the registration of innovative products shall be within 5 years from the date of authorization announcement for patent; or the application of the patent for core technology invention has been made public by the patent administrative authority directly under the State Council and the Patent Search and Consultation Center of China National Intellectual Property Administration has issued the search report, in which the core technology protocol of the product should be specified to be novel and creative;
(II) The applicant has completed the preliminary study on the product and owns the basically finalized product, the study process is true and controlled, and the study data is complete and traceable;
(III) The primary principle of operation or functional mechanism of the product is the first of its kind in China, the product performance or safety has been substantially improved compared with the predicate products, and the technology of product reaches the international advanced level, and has significant value in clinical application.
Article 69 In case of applying for the applicability to procedures for the registration of innovative products, the applicant shall submit an application for the review of innovative medical device to the NMPA after the product is basically finalized. The NMPA shall organize experts to conduct the review and include those meeting the requirements in the procedures for registration of innovative products.
Article 70 For a medical device registration application applicable to the procedures for registration of innovative products, the NMPA and institutions that undertake the relevant technical work shall designate special personnel to take charge according to their responsibilities, communicate in a timely manner and provide guidance.
For a medical device subject to the procedures for registration of innovative products, the CMDE can communicate with the applicant on major technical issues, major safety issues, clinical trial protocol, summary and evaluation of the results of phased clinical trials, and other issues in product R&D before the acceptance of registration application and during the process of technical evaluation.
Article 71 For a medical device subject to the procedures for registration of innovative products, if the applicant voluntarily requires to terminate the procedure, or the NMPA identifies that the medical device no longer meets the requirements of the procedures for registration of innovative products, the NMPA shall terminate the registration procedure for the relevant product and inform the applicant.
Article 72 For a medical device subject to the procedures for registration of innovative products, if the applicant fails to apply for registration within the specified time limit, the procedures for the registration of innovative products shall be no longer applicable.
Section II Priority Registration Procedures
Article 73 For medical devices that meet any of the following circumstances, an application may be submitted for the applicability to priority registration procedures:
(I) Medical devices used to diagnose or treat rare diseases or malignant tumors and having significant clinical advantages, or those used to diagnose or treat the diseases which are specific to or more prevalent among the elderly and against which no effective diagnostic or treatment means exist currently, or those intended for children and have significant clinical advantages, or those which are in urgent clinical need and in respect of which there is currently no predicate device approved to be registered in China;
(II) Medical devices that have been listed in the national science and technology major project or national key R&D project;
(III) Other medical devices that may be applicable to the priority registration procedures as specified by the NMPA.
Article 74 In case of applying for the applicability to priority registration procedures, the applicants shall submit an application for the applicability to priority registration procedures to the NMPA at the time of applying for medical device registration. For the circumstances specified in Paragraph one of Article 73, the NMPA shall organize experts to review the application, and include those meeting the requirements in the priority registration procedures; for the circumstances specified in Paragraph two of Article 73, the CMDE shall evaluate the application, and include those meeting the requirements in the priority registration procedures; for the circumstances specified in Paragraph three of Article 73, the NMPA shall solicit opinions widely and organize experts to conduct demonstration to determine whether to include in the priority registration procedures or not.
Article 75 For medical device registration applications included in the priority registration procedures, the NMPA shall conduct the review and approval with priority, and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall arrange the quality management system inspection for medical device registration with priority.
In the process of technical evaluation for medical devices included in the priority registration procedures, the CMDE should actively communicate with the applicants in accordance with relevant regulations and if necessary, may arrange for special communication.
Section III Emergency Registration Procedures
Article 76 The NMPA may carry out emergency registration procedures for medical devices which are in urgent need for handling public health emergencies and there is no equivalent product marketed in China, or those although having equivalent products marketed in China but insufficient product supply cannot meet the urgent need for handling public health emergencies.
Article 77 In case of applying for the applicability to the emergency registration procedures, the applicants shall submit an application for emergency registration to the NMPA. Those complying with the requirements shall be included in the emergency registration procedures.
Article 78 For medical device registration applications subject to emergency registration procedures, the NMPA shall handle them in accordance with the requirements of unified command, early intervention, on-demand review and scientific approval, and carry out the testing, system verification and technical evaluation of medical devices in parallel.
Chapter V Change Registration and Registration Renewal
Section I Change Registration
Article 79 The registrant shall take the initiative to conduct post-marketing study of medical devices, carry out further validation for the safety, effectiveness and quality control of medical devices and strengthen continuous management of marketed medical devices.
Where there is any substantial change in the design, raw materials, manufacturing process, scope of application and method of application of Class II and Class Ⅲ medical devices that have been registered, which may affect the safety and effectiveness of medical devices, the registrant shall apply to the original registration authority for the change registration procedures; any other changes shall be filed to original registration authority within 30 days from the date of change.
The product name, model, specification, structure and composition, scope of application, product technical requirements, and the address of manufacturing site of imported medical devices, etc. indicated in the registration certificate are the items requiring change registration as specified in the preceding paragraph. The name and address of the registrant and the agent, etc. are the items requiring filing as specified in the preceding paragraph. In case of any change in the address of manufacturing site of domestic medical devices, the registrant shall conduct filing after the corresponding change of manufacturing licensing.
In case of any other changes, the registrant shall complete relevant work in accordance with the requirements of quality management system and report to the drug regulatory departments as required.
Article 80 For the application for change registration, the technical evaluation institution shall focus on evaluating the changes and give comments on product safety, effectiveness and quality control after the change.
During the technical evaluation of the application for change registration, the drug regulatory department may conduct the inspection on quality management system if it deems necessary.
Article 81 The amendment sheet to registration of medical device shall be used in conjunction with the original medical device registration certificate and its validity period shall be the same with that of the original medical device registration certificate.
Section II Registration Renewal
Article 82 Where it is required to extend the period of validity of the medical device registration certificate, the registrant shall submit application for registration renewal to the drug regulatory department six months before the expiration of period of validity and submit registration dossier according to corresponding requirements.
Except for the situations specified in Article 83, the drug regulatory department receiving the application for registration renewal shall make a decision for the renewal before the expiration of period of validity of the medical device registration certificate. If the decision is not made within the specified time, the renewal is considered approved.
Article 83 The registration renewal shall not be approved in any of the following circumstances:
(I) The applicant fails to submit the application for registration renewal within the specified period;
(II) The medical device under application for registration renewal cannot meet new requirements as new mandatory standards for medical devices have been issued and implemented;
(III) Medical devices approved with conditions fail to finish the items as specified in the medical device registration certificate within the specified time limit.
Article 84 Where the approval time of registration renewal is within the validity period of the original registration certificate, the validity period of the certificate for registration renewal shall start from the next day after the expiration of the original registration certificate; if the approval time is not within the validity period of the original registration certificate, the validity period of the certificate for registration renewal shall start from the approval date of registration renewal.
Article 85 Where provisions concerning acceptance and approval procedures of applications for change registration and registration renewal of medical devices are not outlined in this Chapter, Chapter Ⅲ hereof shall prevail.
Chapter VI Medical Device Filing
Article 86 Filing for a class I medical device shall be conducted prior to manufacturing.
Article 87 While conducting medical device filing, the filing applicant shall submit filing documents to the drug regulatory department in accordance with the Regulations on Supervision and Administration of Medical Devices, so as to obtain the filing number.
Article 88 For a filed medical device, where the contents set forth in the filing information table of the medical device and filed product technical requirements have been changed, the filing applicant shall apply for change of filing and submit a description of changes and related supporting documents to the original filing authority. The drug regulatory department shall describe the changes in filing information.
Article 89 For any filed medical device, if the management category is adjusted to Class II or Class III, the registration shall be applied in accordance with the relevant regulations of the Provisions.
Chapter VII Time Limit
Article 90 The time limit specified in the Provisions is the maximum time for acceptance, technical evaluation, inspection and approval of medical device registration. The time limit for work related to special registration procedures shall be implemented in accordance with relevant provisions of special registration procedures.
The CMDE and other specialized technical institutions shall determine the work procedures and time limit of its authority and made them to the public.
Article 91 After receiving the application for medical device registration and that of clinical trials, the drug regulatory department shall forward the registration dossier to the technical evaluation department within 3 days from the date of acceptance. For the requirements for acceptance of clinical trial applications, Article 53 of the Provisions shall apply.
Article 92 The time limit for technical evaluation of medical device registration shall comply with the following provisions:
(I) The time limit for technical evaluation of the application for medical device clinical trial is 60 days, and that for technical evaluation after the supplement of application materials is 40 days;
(II) The time limit for technical evaluation of applications for registration, change registration and registration renewal of Class II medical devices is 60 days, and that for technical evaluation after the supplement of application materials is 60 days;
(III) The time limit for technical evaluation of applications for registration, change registration and registration renewal of Class III medical devices is 90 days, and that for technical evaluation after the supplement of application materials is 60 days.
Article 93 The time limit for the inspection on quality management system of domestic Class III medical devices shall comply with the following provisions:
(I) The CMDE shall notify the drug regulatory departments of relevant provinces, autonomous regions and municipalities directly under the central government to initiate inspection within 10 days upon the acceptance of medical device registration applications;
(II) The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall, in principle, complete the inspection and feedback the inspection situation and results thereof as well as other relevant materials to the CMDE within 30 days upon the receipt of the notification of inspection.
Article 94 The drug regulatory department accepting registration application should make a decision within 20 days after receiving the evaluation comments.
Article 95 The drug regulatory department shall issue and deliver relevant certificates of administrative license within 10 days from the date when the decision of review and approval of medical device registration is made.
Article 96 Where the time limit needs to be extended due to characteristics of the product or special circumstances occurred in technical evaluation and inspection, the extension shall not exceed 1/2 of the original time limit. Upon approval by the responsible person of relevant technical institutions involved in the evaluation and inspection of medical devices, the technical institution extending the time limit shall inform the applicant in writing and notify other relevant technical institutions.
Article 97 The original issuing authority shall re-issue a new medical device registration certificate within 20 days upon the receipt of the application.
Article 98 The time taken for the following circumstances shall not be counted into the relevant time limit for work:
(I) Time taken by the applicant to supplement materials or perform rectification after inspection, etc.;
(II) Time taken for inspection delay attributed to the applicant;
(III) Time taken for hiring external experts for consultation, the time for expert consultation meetings, and the time for joint evaluation with the drug evaluation institution for drug-device combination products;
(IV) Time taken during the suspension of review and approval as per regulations;
(V) Time taken for the quality management system inspection.
Article 99 The time limit specified in the Provisions is calculated by working days.
Chapter VIII Supervision and Administration
Article 100 The drug regulatory department shall enhance the supervisory inspection on the R&D of medical devices, and when necessary, it may conduct extended inspection for units and individuals providing products or services for the R&D of medical devices. Units and individuals concerned shall cooperate, provide relevant documents and dossiers and shall not refuse, conceal or obstruct.
Article 101 The NMPA shall establish and implement a system of unique device identification by steps. Applicants or filing entities shall submit the information related to unique device identification in accordance with relevant regulations to ensure that the data is authentic, accurate and traceable.
Article 102 The NMPA shall promptly communicate the information of the agent to the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government where the agent is located. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall organize routine supervision and administration to the agents within their own administrative regions.
Article 103 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall, according to the filing of medical device clinical trial institutions, organize the post-filing supervisory inspection on clinical trial institutions that have been filed within their administrative regions. For the newly filed medical device clinical trial institutions, the supervisory inspection shall be carried out within 60 days after filing.
Drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall organize the routine supervisory inspection on the compliance with the GCP by medical device clinical trial institutions within their administrative regions to ensure the continuous compliance with requirements. The NMPA shall conduct supervisory inspection on medical device clinical trial institutions as required.
Article 104 Drug regulatory departments may conduct on-site inspection on the authenticity, accuracy, completeness, standardization and traceability of clinical trials as they deem it necessary.
Article 105 In case of identifying that any filing materials is non-standardized in the post-filing supervision, drug regulatory departments undertaking the filing of Class I medical devices shall order the filing entity to make rectification within a time limit.
Article 106 Where a drug regulatory department fails to timely identify systematic or regional risks in the administration of medical device registration within its administrative region, or fails to timely eliminate systematic or regional potential hazards in the administration of medical device registration within its administrative region, the superior drug regulatory department may make inquiries with the principal responsible person of this drug regulatory department at a lower level.
Chapter IX Legal Responsibilities
Article 107 The filing applicant that fails to file changes according to the requirements and is in violation of Article 79 of the Provisions shall be ordered to make rectification within the time limit; if no rectification is made within the time limit, the filing applicant shall be imposed a fine of not less than RMB 10,000 but not more than RMB 30,000.
Article 108 The registrant that fails to comply with the GCP in conducting clinical trials of medical devices shall be punished according to Article 94 of the Regulations on Supervision and Administration of Medical Devices.
Article 109 Where medical device technical evaluation institution fails to perform their duties according to the Provisions, which results in major mistakes in review, the drug regulatory departments shall order them to make rectification, circulate a notice of criticism, or issue a warning; where serious consequences are caused, the punishment shall be imposed on the legal representative, the principal responsible person, the direct managers and other responsible persons from the unit concerned according to law.
Article 110 Any personnel of drug regulatory departments who abuses his/her power, neglects his/her duty or engages in malpractices for personal gain in violation of the Provisions shall be punished according to law.
Chapter X Supplementary Provisions
Article 111 Medical device registration or filing units shall in principle be classified according to the technical mechanism, structural composition, performance indicators and scope of application of the product.
Article 112 A medical device approved for registration refers to the medical device that is produced within the validity period of the registration certificate for medical devices and is consistent with the contents limited in the registration certificate for medical devices and the annexes thereof.
Article 113 Where, in the column of “Structure and Components”of a medical device registration certificate, the combining components listed is used on the original registered product for the purpose of replacing consumables, after-sales service, and maintenance, etc., they may be sold individually.
Article 114 In case of applying for medical device registration, change registration, and clinical trial approval, an applicant may reference master files of registered medical devices upon authorization by the owner of medical device master files. The procedures related to the registration of medical device master files shall be specified separately.
Article 115 The format of the medical device registration certificate shall be prepared by NMPA.
The registration number shall be arranged in the following form:
×1械注×2××××3×4××5××××6, among which,
×1 shall be the abbreviation of the place where the registration department is located.
The character “国” shall refer to domestic class III medical devices and import class II and III medical devices.
The abbreviation of the provinces, autonomous regions and municipalities directly under the central government where the registration department is located shall be adopted for domestic class II medical devices.
×2 shall indicate the form of registration.
The character “准” applies to domestic medical devices.
The character “进” applies to import medical devices.
The character “许” applies to medical devices from Hong Kong SAR, Macao, and Chinese Taipei.
××××3 shall indicate the year of initial registration.
×4 shall indicate the classification.
××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. In case of the management classification changed, a new registration number shall be issued.
Article 116 The filing number for class I medical device shall be arranged in the following form:
×1械备××××2××××3, among which,
×1 shall be the abbreviation of the place where the filing department is located.
The character “国” shall refer to import class I medical devices.
The abbreviation of the provinces, autonomous regions and municipalities directly under the central government combines the abbreviation of city divided into districts where filing department is located (if there is no corresponding city divided into districts, only use the abbreviation of province, autonomous region or municipality directly under the central government) shall be adopted for domestic class I medical device.
××××2 shall indicate the year of filing.
××××3 shall indicate the serial number of filing.
Article 117 Electronic Medical Device Registration Certificate and Amendment Sheet to Registration of Medical Device issued by drug regulatory departments shall have the same legal force as paper materials.
Article 118 NMPA may, according to necessity, authorize the drug regulatory departments or technical organizations of provinces, autonomous regions and municipalities directly under the central government and relevant social organizations to conduct the specific work.
Article 119 Drug regulatory 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 Chapter IV in the Provisions and report to the NMPA for filing.
Article 120 The charging items and the charging standards for medical device registration shall be determined in accordance with the relevant regulations formulated by the competent finance department and the competent pricing department of the State Council.
Article 121 The Provisions for In-vitro Diagnostic Reagent Registration and Filing shall be applicable to the registration and filing of in-vitro diagnostic reagents administered as medical devices.
Article 122 Relevant regulations on the supervision and administration of customized medical devices shall be formulated separately by the NMPA.
The provisions related to registration management of drug-device combination products shall be separately formulated by the NMPA.
The provisions related to the emergency use of medical devices shall be formulated by the NMPA in conjunction with other authorities concerned.
Article 123 The medical devices from Hong Kong SAR, Macao, and Chinese Taipei shall be registered and filed by reference to the import medical devices.
Article 124 The Provisions shall go into effect as of October 1, 2021. The Provisions for Medical Device Registration promulgated on July 30, 2014 (Decree No. 4 of the former China Food and Drug Administration) is annulled simultaneously.
Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.
