Order of the National Medical Products Administration

No. 4

　　The “Administrative Measures for the Registration of Medical Devices” were reviewed and approved at the Bureau Meeting of the State Administration for Food and Drug Supervision on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

　　Director 　　Zhang Yong

　　July 30, 2014

Medical Device Registration and Management Measures

Chapter One General Then

　　Article 1 　To standardize the registration and filing management of medical devices and ensure their safety and effectiveness, these Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 2 　Medical devices sold and used within the territory of the People's Republic of China shall, in accordance with the provisions of these Measures, apply for registration or file a record.

　 　Article 3 　Medical device registration is the process by which the food and drug administration, upon application by the medical device registrant and in accordance with statutory procedures, systematically evaluates the safety and effectiveness of the medical device proposed for market launch, as well as the results of related studies, to determine whether to approve the application.

　　Medical device registration refers to the registrant of a medical device submitting registration documents to the food and drug administration department, which then archives and keeps these documents for future reference.

　　 Article 4 　Medical device registration and filing shall adhere to the principles of openness, fairness, and impartiality.

　 　Article 5 　Class I medical devices are subject to filing-based management. Class II and Class III medical devices are subject to registration-based management.

　　For the filing of Class I medical devices within the territory, the filer shall submit the filing materials to the food and drug administration department at the prefectural-level city.

　　Class II medical devices within the territory are reviewed and approved by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government, and upon approval, a medical device registration certificate is issued.

　　Class III medical devices within the territory are reviewed and approved by the National Medical Products Administration, which then issues a medical device registration certificate.

　　For the filing of Class I medical devices imported into China, the filer shall submit the filing materials to the National Medical Products Administration.

　　Class II and Class III medical devices imported into China are reviewed and approved by the National Medical Products Administration, which then issues a medical device registration certificate.

　　The registration and filing of medical devices in the Hong Kong, Macao, and Taiwan regions shall be handled in accordance with the procedures for imported medical devices.

　 　Article 6 　The registrant and filer of medical devices, acting in their own name, bring the products to market and bear legal responsibility for them.

　　 Article 7 　The food and drug administration department promptly discloses, in accordance with the law, information related to the registration and filing of medical devices. Applicants can check the progress and results of their applications, and the public can access the approved results.

　　 Article 8 　The state encourages research and innovation in medical devices, implements special approval procedures for innovative medical devices, promotes the dissemination and application of new medical device technologies, and drives the development of the medical device industry.

　　Chapter 2: Basic Requirements

　　 Article 9 　Applicants and filers for medical device registration shall establish a quality management system related to product development and manufacturing, and ensure its effective operation.

　　When applying for registration of domestically produced medical devices that have been approved under the Special Approval Procedure for Innovative Medical Devices, if the samples are to be manufactured by another enterprise, such enterprise must be a medical device manufacturer with the appropriate production scope. For applications for registration of domestically produced medical devices that are not approved under the Special Approval Procedure for Innovative Medical Devices, samples may not be entrusted to other enterprises for manufacturing.

　　Article 10 Personnel handling medical device registration or filing shall possess the relevant professional knowledge and be familiar with the laws, regulations, rules, and technical requirements governing medical device registration or filing.

　　Article 11 Applicants or registrants applying for registration or filing shall comply with the basic requirements for the safety and effectiveness of medical devices, ensure that the development process is conducted in a standardized manner, and guarantee that all data are authentic, complete, and traceable.

　　Article 12: The materials submitted for registration or filing shall be in Chinese. If the materials are translated from foreign-language sources, the original documents must also be provided. When citing unpublished documents, proof of permission from the owner of the documents must be provided.

　　The applicant and the filing entity are responsible for the authenticity of the submitted materials.

　　Article 13 Imported medical devices applying for registration or filing shall have already been approved for marketing and sale in the country (or region) where the applicant or filer is registered or where the manufacturing facility is located.

　　If the applicant or registrant’s country (or region) of registration or manufacturing address does not regulate this product as a medical device, the applicant or registrant must provide relevant supporting documents, including proof that the product is permitted for marketing and sale in the applicant’s or registrant’s country (or region) of registration or manufacturing address.

　　Article 14 The applicant or registrant located outside China shall appoint a representative agency established in China or a corporate legal entity designated within China as their agent to cooperate with the overseas applicant or registrant in carrying out relevant activities.

　　In addition to handling the registration or filing of medical devices, the agent shall also assume the following responsibilities:

　　(1) Liaison with the relevant food and drug administration department, overseas applicants, or filers;

　　(2) Accurately and truthfully convey the relevant regulatory and technical requirements to the applicant or registrant;

　　(3) Collect post-market adverse event information on medical devices and provide feedback to the overseas registrant or filer, while also reporting to the relevant food and drug administration authorities.

　　(4) Coordinate product recall efforts for medical devices after they have been launched on the market, and report to the relevant food and drug administration authorities;

　　(5) Other joint and several liabilities involving product quality and after-sales service.

Chapter 3: Product Technical Requirements and Registration Testing

　　Article 15 　The applicant or registrant shall prepare the product technical requirements for the medical device intended for registration or filing. For Class I medical devices, the product technical requirements shall be submitted to the food and drug administration department by the registrant when filing the registration. For Class II and Class III medical devices, the product technical requirements shall be approved by the food and drug administration department upon approval of the registration.

　　The technical requirements for products primarily include performance specifications and testing methods for finished medical devices. Among these, performance specifications refer to the functional and safety indicators of the finished product that can be objectively evaluated, as well as other indicators related to quality control.

　　Medical devices marketed in China shall comply with the product technical requirements that have been approved through registration or filed for record.

　　Article 16 　For the registration of Class II and Class III medical devices, a registration inspection shall be conducted. Medical device inspection institutions shall perform the registration inspection on the relevant products in accordance with the product’s technical requirements.

　　The production of registration inspection samples shall comply with the relevant requirements of the medical device quality management system. Only those that pass the registration inspection may proceed to clinical trials or apply for registration.

　　For the filing of Class I medical devices, the filer may submit a self-inspection report for the product.

　　Article 17 To apply for registration inspection, the applicant shall provide the inspection agency with the relevant technical documentation required for registration inspection, samples for registration inspection, and product technical specifications.

　　Article 18 Medical device testing institutions shall possess the necessary qualifications for medical device testing, conduct testing within their accredited scope, and perform a preliminary evaluation of the product technical requirements submitted by the applicant. The preliminary evaluation意见 will be issued to the applicant together with the registration testing report.

　　Medical devices not yet included in the scope of testing institutions accredited by the medical device inspection agency shall be tested by qualified inspection agencies designated by the relevant registration and approval authorities.

　　Article 19 The products tested within the same registration unit should be representative of the safety and effectiveness of other products within that registration unit.

Chapter 4: Clinical Evaluation

　　Article 20 　Clinical evaluation of medical devices refers to the process by which the applicant or registrant confirms whether a product meets its intended use requirements or scope of application based on information such as clinical literature, clinical experience data, and clinical trials.

　　Article 21 Clinical evaluation data refer to the documents generated by the applicant or registrant during the clinical evaluation process.

　　For those requiring clinical trials, the submitted clinical evaluation data shall include the clinical trial protocol and the clinical trial report.

　　Article 22 For the filing of Class I medical devices, clinical trials are not required. For the registration of Class II and Class III medical devices, clinical trials must be conducted.

　　Clinical trials may be exempted under any of the following circumstances:

　　(1) The working mechanism is clearly defined, the design has been finalized, the production process is well-established, and the medical device of the same type that is already on the market has been clinically used for many years with no record of serious adverse events, and its conventional use remains unchanged.

　　(2) The medical device can be demonstrated to be safe and effective through non-clinical evaluation;

　　(3) The safety and effectiveness of the medical device can be demonstrated by analyzing and evaluating data obtained from clinical trials or clinical use of the same type of medical device.

　　The catalog of medical devices exempt from clinical trials is formulated, adjusted, and published by the National Medical Products Administration. For products not included in the catalog of medical devices exempt from clinical trials, if analysis and evaluation of data obtained from clinical trials or clinical use of similar medical devices demonstrate that the medical device is safe and effective, the applicant may state this in the registration application and submit relevant supporting documentation.

　　Article 23 Clinical trials of medical devices shall be conducted within qualified clinical trial institutions in accordance with the requirements of the Good Clinical Practice for Medical Device Clinical Trials. The production of clinical trial samples shall comply with the relevant requirements of the medical device quality management system.

　　Article 24 Class III medical devices that pose a higher risk to human subjects during clinical trials shall be approved by the National Medical Products Administration. The catalog of Class III medical devices requiring clinical trial approval shall be formulated, adjusted, and published by the National Medical Products Administration.

　　Article 25 Clinical trial approval refers to the process by which the National Medical Products Administration, based on the applicant’s submission, conducts a comprehensive assessment of the risk level of the medical device intended for clinical trials, the clinical trial protocol, and the report on the comparative analysis of clinical benefits and risks, in order to determine whether to approve the conduct of the clinical trial.

　 　Article 26 For medical device clinical trial approvals, applicants shall submit the application materials to the National Medical Products Administration in accordance with the relevant requirements.

　　Article 27 　After the National Medical Products Administration accepts an application for approval of clinical trials for medical devices, it shall, within 3 working days from the date of acceptance, forward the submitted documentation to the medical device technical review agency.

　　The technical review agency shall complete the technical review within 40 working days. The National Medical Products Administration shall make a decision within 20 working days after the completion of the technical review. If the clinical trial is approved, a clinical trial approval document for medical devices shall be issued; if the application is not approved, the reasons shall be set forth in writing.

　　Article 28 　During the technical review process, if the applicant is required to supplement or correct materials, the technical review agency shall inform the applicant of all necessary corrections in a single notice. The applicant shall submit the supplementary materials once within one year, in accordance with the requirements set forth in the notice of correction. The technical review agency shall complete the technical review within 40 working days from the date of receipt of the supplementary materials. The time taken by the applicant to submit supplementary materials shall not be included in the review deadline.

　　If the applicant fails to submit the supplementary materials within the prescribed time limit, the technical review agency shall terminate the technical review and recommend that the application not be approved. After approval by the National Medical Products Administration, a decision of non-approval shall be issued.

　　Article 29 　The National Medical Products Administration shall revoke the previously granted clinical trial approval documents for medical devices if any of the following circumstances exist:

　　(1) The clinical trial application materials are false;

　　(2) There is already recent research confirming that the ethics and scientific validity of the originally approved clinical trials have issues;

　　(3) Other circumstances that should be revoked.

　　Article 30: Clinical trials of medical devices shall be conducted within three years after approval. If the trials are not initiated within the prescribed period, the original approval document shall become invalid automatically. Should it still be necessary to conduct clinical trials, a new application shall be submitted.

　　Chapter 5: Product Registration

　　Article 31 To apply for medical device registration, the applicant shall submit the application materials to the food and drug administration department in accordance with the relevant requirements.

　　Article 32 After receiving the application, the food and drug administration department will conduct a formal review of the submitted documentation and handle it accordingly based on the following circumstances:

　　(1) If the application falls within the purview of this department and the submitted documents are complete and meet the requirements of the formal review, it shall be accepted.

　　(2) If the submitted materials contain errors that can be corrected on the spot, the applicant should be allowed to correct them on the spot.

　　(3) If the submitted documentation is incomplete or does not meet the requirements of the formal review, the applicant shall be notified within 5 working days of all the items that need to be corrected. If no notification is provided within the specified period, the application shall be deemed to have been accepted as of the date on which the documentation was received.

　　(4) If the application does not fall within the purview of this department’s authority, the applicant shall be immediately informed that the application will not be accepted.

　　The food and drug administration shall issue a notice, stamped with the department’s official seal and dated, indicating whether it has accepted or rejected a medical device registration application.

　　Article 33 The food and drug administration department that accepts the registration application shall, within 3 working days from the date of acceptance, forward the submitted documentation to the technical review agency.

　　The technical review agency shall complete the technical review for Class II medical device registration within 60 working days and complete the technical review for Class III medical device registration within 90 working days.

　　For products involving externally hired experts for review or combination drug-device products that require joint review with the drug regulatory authority, the time required for such reviews shall not be included in the overall review period. The technical review agency shall notify the applicant in writing of the time required for these additional reviews.

　　Article 34 When organizing technical reviews of products, the food and drug administration may access the original research data and conduct inspections of the applicant’s quality management system related to product development and manufacturing.

　　The verification of the quality management system for the registration of Class II and Class III medical devices within China shall be conducted by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government. Specifically, for the registration of Class III medical devices within China, the technical review agency of the National Medical Products Administration will notify the relevant provincial, autonomous regional, and municipal food and drug administration departments to carry out the verification and, if necessary, participate in the verification themselves. The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall complete the system verification within 30 working days according to the relevant requirements.

　　When conducting technical reviews of Class II and Class III medical devices imported into China, if the Technical Review Agency of the National Medical Products Administration deems it necessary to verify the quality management system, it shall notify the Quality Management System Inspection Technical Agency of the National Medical Products Administration to carry out the verification in accordance with relevant requirements. If necessary, the Technical Review Agency may participate in the verification process.

　　The time spent on quality management system verification is not included in the review deadline.

　　Article 35 　During the technical review process, if the applicant is required to supplement or correct materials, the technical review agency shall notify the applicant once of all the items that need to be corrected. The applicant shall submit the supplementary materials in one go within one year, as specified in the notice of correction. The technical review agency shall complete the technical review within 60 working days from the date of receipt of the supplementary materials. The time taken by the applicant to submit supplementary materials shall not be counted toward the review deadline.

　　If the applicant disagrees with the content of the notice regarding supplementary materials, they may submit a written statement to the relevant technical review agency, stating their reasons and providing supporting technical documentation.

　　If the applicant fails to submit the supplementary materials within the prescribed time limit, the technical review agency shall terminate the technical review and recommend against registration. After approval by the food and drug administration department, a decision will be made to deny registration.

　 　Article 36 The food and drug administration department that accepts registration applications shall make a decision within 20 working days after the completion of the technical review. For applications that meet the requirements for safety and effectiveness, registration shall be granted, and the medical device registration certificate shall be issued within 10 working days from the date of the approval decision. The approved product technical requirements will be provided to the applicant in the form of an annex. In cases where registration is not granted, the department shall provide a written explanation of the reasons and simultaneously inform the applicant of their right to request a reconsideration and to file an administrative reconsideration or bring an administrative lawsuit in accordance with the law.

　　The medical device registration certificate is valid for 5 years.

　 　Article 37 The registration items for medical devices include licensing items and registration items. Licensing items encompass the product name, model, specifications, structure and composition, intended use, technical requirements for the product, and the manufacturing address of imported medical devices, among others. Registration items include the name and address of the registrant, the name and address of the agent, and the manufacturing address of medical devices produced within China, among others.

　　Article 38 For medical devices urgently needed to treat rare diseases and respond to public health emergencies, the food and drug administration may, when approving the registration of such devices, require applicants to carry out additional relevant work after the product is launched on the market, and specify these requirements in the medical device registration certificate.

　　Article 39 For a registration application that has been accepted, if any of the following circumstances apply, the food and drug administration shall make a decision not to register and notify the applicant:

　　(1) The applicant’s studies on the safety and effectiveness of the medical device intended for marketing, as well as their results, are insufficient to demonstrate that the product is safe and effective.

　　(2) The registration and submission materials are false;

　　(3) The content of the registration and submission materials is confusing and contradictory;

　　(4) The content of the registration and submission materials is significantly inconsistent with the declared project;

　　(5) Other circumstances under which registration will not be granted.

　　Article 40 For a registration application that has already been accepted, the applicant may, prior to the issuance of an administrative licensing decision, submit a request to the food and drug administration department that受理 the application to withdraw the registration application and related materials, and provide a statement of reasons.

　　Article 41 For registration applications that have already been accepted, if there is evidence suggesting that the submitted registration documents may be false, the food and drug administration department may suspend the approval process. After verification, the department will either continue the review based on the verification findings or make a decision not to grant registration.

　　Article 42 If the applicant disagrees with the decision made by the food and drug administration to deny registration, they may, within 20 working days from the date of receiving the notice of the denial, submit a request for reconsideration to the food and drug administration that made the original approval decision. The content of the reconsideration request shall be limited solely to the original application items and the original submitted documentation.

　　Article 43 The food and drug administration shall, within 30 working days from the date of receipt of the request for reconsideration, make a decision on the reconsideration and notify the applicant in writing. If the original decision is upheld, the food and drug administration will no longer accept any subsequent requests for reconsideration submitted by the applicant.

　　Article 44 If the applicant objects to the decision made by the food and drug administration not to register the application and has already filed an administrative reconsideration or initiated an administrative lawsuit, the food and drug administration will not accept the applicant’s request for a review.

　　Article 45 In the event that a medical device registration certificate is lost, the registrant shall immediately publish a notice of loss in the media designated by the original issuing authority. One month after the date of publication of the notice of loss, the registrant may apply to the original issuing authority for a replacement certificate, which the original issuing authority shall issue within 20 working days.

　 　Article 46 If a medical device registration application directly involves significant interests between the applicant and other parties, the food and drug administration shall inform the applicant and any interested parties that they may, in accordance with laws, regulations, and other provisions of the National Medical Products Administration, exercise their right to request a hearing. When reviewing a medical device registration application, if the food and drug administration deems the matter to be a major licensing issue involving public interest, it shall publicly announce this fact and hold a hearing.

　　Article 47 　For newly developed medical devices that have not yet been included in the classification catalog, applicants may either directly apply for registration as Class III medical devices, or—based on the classification rules—determine the product’s classification and then apply to the National Medical Products Administration for confirmation of the classification before proceeding with product registration or filing.

　　For direct applications for registration of Class III medical devices, the National Medical Products Administration will determine the classification based on the level of risk. If a medical device manufactured within China is classified as Class II, the National Medical Products Administration will forward the application documents to the food and drug administration department of the province, autonomous region, or municipality where the applicant is located for review and approval. If a medical device manufactured within China is classified as Class I, the National Medical Products Administration will forward the application documents to the food and drug administration department at the prefectural-level city where the applicant is located for filing.

　　Article 48 　In the event of a patent rights dispute arising during the examination process of a registration application or after approval, such disputes shall be handled in accordance with applicable laws and regulations.

　　Chapter 6: Registration Changes

　　Article 49 　If the contents specified in the registration certificate and its attachments for Class II and Class III medical devices that have already been registered change, the registrant shall apply to the original registration authority for a registration amendment and submit the required documentation in accordance with relevant requirements.

　　If there are changes to the product name, model number, specifications, structure and composition, intended use, technical requirements for the product, or the manufacturing address of imported medical devices, the registrant shall apply to the original registration authority for a change in the licensed items.

　　If the name and address of the registrant, or the name and address of the agent, change, the registrant shall apply to the original registration authority for a change in the registered information. If the manufacturing address of an in-country medical device changes, the registrant shall complete the change in the registered information after the corresponding manufacturing license has been amended.

　　Article 50 If the documentation for changes to registered items meets the requirements, the food and drug administration shall issue the medical device registration change document within 10 working days. If the documentation for changes to registered items is incomplete or does not meet the formal review requirements, the food and drug administration shall notify the applicant once of all the information that needs to be corrected.

　　 Article 51 For changes to licensed matters, the technical review agency shall focus its review on the changed portions and assess whether the product, following these changes, remains safe and effective.

　　The food and drug administration department that accepts applications for changes to licensed matters shall organize technical reviews within the time limits specified in Chapter V of these Measures.

　　Article 52 　The registration amendment document for medical devices shall be used in conjunction with the original medical device registration certificate, and its validity period shall be the same as that of the registration certificate. After obtaining the registration amendment document, the registrant shall independently modify the product’s technical requirements, instructions, and labels according to the content of the amendment.

　　Article 53 　For the acceptance and approval procedures of applications for changes to licensed matters, where this chapter does not provide specific provisions, the relevant provisions of Chapter 5 of these Measures shall apply.

　　Chapter 7: Renewal of Registration

　　Article 54 　If the validity period of a medical device registration certificate is about to expire and the registrant wishes to renew the registration, the registrant shall apply to the food and drug administration authority for renewal registration at least 6 months before the expiration date of the medical device registration certificate, and submit the required application materials in accordance with relevant requirements.

　　Except in the circumstances specified in Article 55 of these Measures, the food and drug administration department receiving an application for renewal of registration shall make a decision to approve the renewal before the expiration date of the medical device registration certificate. If no decision is made within the prescribed time limit, the application shall be deemed to have been approved.

　　Article 55 Registration shall not be renewed if any of the following circumstances apply:

　　(1) The registrant fails to submit an application for renewal of registration within the prescribed time limit;

　　(2) The mandatory standards for medical devices have been revised, and this medical device no longer meets the new requirements.

　　(3) For medical devices intended for the treatment of rare diseases and urgently needed to respond to public health emergencies, if the approval authority, when granting market authorization, sets forth requirements that the registrant fails to fulfill within the prescribed time limit regarding matters specified in the medical device registration certificate, the approval authority shall take appropriate action.

　 　Article 56 For the acceptance and approval procedures of applications for the renewal of medical device registrations, where this chapter does not provide specific provisions, the relevant provisions of Chapter 5 of these Measures shall apply.

　　Chapter 8: Product Filing

　　 Article 57 　Before manufacturing Class I medical devices, product registration must be completed.

　　Article 58 To register medical devices, the registrant shall submit the registration materials in accordance with the provisions of Article 9 of the "Regulations on the Supervision and Administration of Medical Devices."

　　If the filing materials meet the requirements, the food and drug administration department shall complete the filing on the spot. If the filing materials are incomplete or do not conform to the prescribed format, the department shall notify the filer once of all the items that need to be corrected, and the filer shall make the necessary corrections before proceeding with the filing.

　　For medical devices that have been filed, the food and drug administration department shall prepare a filing certificate in accordance with the prescribed format and publish the information recorded in the filing information form on its website.

　　Article 59 　If the registered medical device undergoes changes in the information recorded on the registration information form or in the technical requirements for the registered product, the registrant shall submit a description of the changes along with relevant supporting documents and apply to the original registration authority for an amendment to the registration information. If the submitted registration materials meet the formal requirements, the food and drug administration department shall record the changes in the amended information and archive the registration materials.

　　Article 60 If the management category of a registered medical device is adjusted, the registrant shall proactively submit a request to the food and drug administration authority to cancel the original registration. If the management category is adjusted to Class II or Class III medical devices, the registrant shall apply for registration in accordance with the provisions of this Regulation.

　　Chapter Nine: Supervision and Management

　　Article 61 　The National Medical Products Administration is responsible for the supervision and management of medical device registration and filing nationwide, and provides oversight and guidance to local food and drug administration departments regarding their medical device registration and filing activities.

　 　Article 62 　The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the supervision and management of medical device registration and filing within their respective administrative areas. They shall organize and carry out inspection and oversight activities and promptly report relevant information to the National Medical Products Administration.

　 　Article 63 The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government shall, in accordance with the principle of jurisdictional management, carry out daily supervision and management of the registration and filing work related to agents of imported medical devices.

　 　Article 64 　The food and drug administration departments at the prefectural-level cities shall conduct regular inspections of the filing work and promptly report relevant information to the food and drug administration departments of the provinces, autonomous regions, and municipalities directly under the central government.

　 　Article 65 If a registered medical device falls under circumstances stipulated by laws and regulations that require cancellation, or if the registration certificate is still valid but the registrant voluntarily requests cancellation, the food and drug administration department shall cancel the registration in accordance with the law and publicly announce the cancellation to the public.

　　Article 66 For medical devices that have already been registered and whose management category has been adjusted from a higher category to a lower one, the medical device registration certificates that are still valid remain effective. If renewal is required, the registrant shall, at least 6 months before the expiration date of the medical device registration certificate, apply to the food and drug administration for renewal registration or file a备案 (filing) according to the newly assigned category.

　　If the management category of a medical device is adjusted from a lower category to a higher category, the registrant shall, in accordance with the provisions of Chapter V of these Measures, apply for registration with the food and drug administration department based on the newly assigned category. The National Medical Products Administration shall specify in its notice of management category adjustment the deadline for completing the adjustment.

　　Article 67 If the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government violate the provisions of these Measures in carrying out medical device registration, the National Medical Products Administration shall order them to make corrections within a specified time limit. If they fail to make corrections within the prescribed time limit, the National Medical Products Administration may directly announce the revocation of the medical device registration certificate.

　　 Article 68 The food and drug administration department, relevant technical institutions, and their staff members are obligated to maintain the confidentiality of the test data and trade secrets submitted by applicants or filers.

　　Chapter Ten: Legal Liability

　　Article 69 Those who provide false information or employ other deceptive practices to obtain a medical device registration certificate shall be penalized in accordance with the provisions of Article 64, Paragraph 1 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Those who provide false information when filing a record shall be penalized in accordance with the provisions of Article 65, Paragraph 2 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 70 　Those who forge, alter, trade, lease, or lend medical device registration certificates shall be penalized in accordance with the provisions of Article 64, Paragraph 2 of the "Regulations on the Supervision and Administration of Medical Devices."

　　 Article 71 In violation of the provisions of these Measures, failure to file a change record for Class I medical devices as required by law or to register changes in registration items for Class II and Class III medical devices shall be penalized in accordance with the relevant provisions on unregistered situations set forth in the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 72 In violation of the provisions of these Measures, failure to amend medical device registration license items in accordance with the law shall be penalized in accordance with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices" pertaining to cases where a medical device registration certificate has not been obtained.

　　 Article 73 If the applicant fails to conduct clinical trials in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and these Measures, the food and drug administration department at or above the county level shall order it to make corrections and may impose a fine of up to 30,000 yuan. In cases of serious violations, the clinical trial must be immediately halted, and any previously obtained clinical trial approval documents shall be revoked.

　　Chapter Eleven: Appendices Then

　　 Article 74 In principle, the registration or filing unit for medical devices is categorized based on the product’s technical principles, structural composition, performance specifications, and intended scope of application.

　　Article 75 Combination components listed under the “Structure and Composition” section of the medical device registration certificate, which are intended for use with the originally registered product for purposes such as replacing consumables, providing after-sales service, or performing repairs, may be sold separately.

　　 Article 76 The format of medical device registration certificates is uniformly prescribed by the National Medical Products Administration.

　　The registration certificate number is arranged as follows:

　　×1 mechanical annotation ×2 ××××3 ×4 ××5 ××××6. Among them:

　　×1 is the abbreviation for the location of the registration and approval authority:

　　Class III medical devices manufactured domestically and Class II and Class III medical devices imported are labeled with the character “Guo”;

　　For Class II medical devices within the territory, the abbreviation of the province, autonomous region, or municipality where the registration and approval authority is located shall be used.

　　×2 is the registration form:

　　The term “zhun” applies to medical devices within the territory;

　　The character “jin” is applicable to imported medical devices;

　　The character “Xu” is applicable to medical devices in the Hong Kong, Macao, and Taiwan regions.

　　××××3 is the year of first registration;

　　×4 is for the product management category;

　　××5 is the product classification code;

　　××××6 is the serial number for first-time registration.

　　For registrations that are renewed, the digits ××××3 and ××××6 remain unchanged. If the product management category is adjusted, a new numbering system must be adopted.

　　Article 77 The arrangement of the registration certificate number for Class I medical devices is as follows:

　　×1 equipment ××××2××××No. 3.

　　Among them:

　　×1 is the abbreviation for the location of the filing authority:

　　Class I medical devices imported are labeled with the character “国”;

　　Class I medical devices within the territory shall be designated by the abbreviation of the province, autonomous region, or municipality where the filing authority is located, followed by the abbreviation of the prefectural-level administrative region where the device is located (if there is no corresponding prefectural-level administrative region, only the abbreviation of the province, autonomous region, or municipality shall be used).

　　××××2 is the year of filing;

　　××××3 is the filing serial number.

　　Article 78 The registration and filing of in vitro diagnostic reagents managed as medical devices shall be governed by the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents."

　　Article 79 　The emergency approval procedure for medical devices and the special approval procedure for innovative medical devices shall be formulated separately by the National Medical Products Administration.

　　Article 80 Based on work requirements, the National Medical Products Administration may entrust the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the central government, or technical institutions and relevant social organizations, with specific tasks related to medical device registration.

　　Article 81 The fee items and fee standards for medical device product registration shall be implemented in accordance with the relevant provisions of the financial and pricing authorities under the State Council.

　　 Article 82 These Measures shall take effect as of October 1, 2014. The “Measures for the Registration and Administration of Medical Devices” (formerly Order No. 16 of the former State Food and Drug Administration), promulgated on August 9, 2004, shall be repealed concurrently.