(deliberated and adopted at the executive meeting of China Food and Drug Administration on June 27, 20 14, promulgated on July 30, 20 14, and effective as of June 30, 20 14) Article 1 In order to standardize the registration and filing management of medical devices and ensure the safety and effectiveness of medical devices, according to the Medical Device Supervision Law,
Article 2 Medical devices sold and used in People's Republic of China (PRC) shall apply for registration or filing in accordance with the provisions of these Measures.
Article 3 Medical device registration is a process in which the food and drug supervision and administration department systematically evaluates the safety and effectiveness research and results of medical devices to be listed according to the application of the medical device registration applicant and legal procedures, so as to decide whether to approve the application. Medical device filing means that the medical device filer submits filing materials to the food and drug supervision and administration department, and the food and drug supervision and administration department files the submitted filing materials for future reference.
Article 4 The registration and filing of medical devices shall follow the principles of openness, fairness and impartiality.
Article 5 Class I medical devices shall be put on record. Class II and Class III medical devices shall be subject to registration management. For the filing of Class I medical devices in China, the filing person shall submit the filing materials to the municipal food and drug supervision and administration department with districts. Category II medical devices in China are examined by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and after approval, medical device registration certificates are issued. Class III medical devices in China are reviewed by China Food and Drug Administration, and medical device registration certificates are issued after approval. For the record-keeping of imported medical devices of Class I, the record-keeping person shall submit the record-keeping materials to China Food and Drug Administration. Imported Class II and Class III medical devices shall be examined by China Food and Drug Administration, and medical device registration certificates shall be issued after approval. The registration of medical devices in Hongkong, Macau and Taiwan Province shall be handled with reference to imported medical devices.
Article 6 Registrants and filers of medical devices put the products on the market in their own names and bear legal responsibilities for the products.
Article 7 The food and drug supervision and administration department shall timely publish the relevant information about the registration and filing of medical devices according to law. Applicants can inquire about the progress and results of examination and approval, and the public can inquire about the results of examination and approval.
Article 8 The State encourages the research and innovation of medical devices, implements special examination and approval for innovative medical devices, promotes the popularization and application of new technologies of medical devices, and promotes the development of medical device industry. Article 9 Applicants and applicants for medical device registration shall establish a quality management system related to product development and production, and maintain its effective operation. When applying for the registration of domestic medical devices approved in accordance with the special examination and approval procedures for innovative medical devices, if the samples are entrusted to other enterprises for production, they shall be entrusted to medical device manufacturers with corresponding production scope for production; When applying for registration of domestic medical devices that have not been approved in accordance with the special approval procedures for innovative medical devices, samples may not be entrusted to other enterprises for production.
Article 10 Personnel handling the registration or filing of medical devices shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and technical requirements for the registration or filing of medical devices.
Article 11 When applying for registration or filing, the applicant or the filer shall follow the basic requirements for the safety and effectiveness of medical devices and ensure that the development process is standardized and all data are true, complete and traceable.
Article 12 The materials for applying for registration or filing shall be in Chinese. If the translation is based on foreign materials, the original text should be provided at the same time. When citing unpublished documents, the supporting documents recognized by the data owner shall be provided. The applicant and the filer are responsible for the authenticity of the information.
Article 13 Imported medical devices applying for registration or filing shall be allowed to be sold in the country (region) where the applicant or filer is registered or the production address is located. If the product is not managed as a medical device in the country (region) where the applicant or the applicant is registered or the production address is located, the applicant or the applicant shall provide relevant supporting documents, including the supporting documents that allow the product to be listed in the country (region) where the registration place or the production address is located.
Article 14 An overseas applicant or filer shall cooperate with the overseas applicant or filer to carry out relevant work through its representative office established in China or entrust an enterprise legal person in China as an agent. In addition to handling the registration or filing of medical devices, agents should also bear the following responsibilities: (1) contacting the corresponding food and drug supervision and administration departments, overseas applicants or filers; (two) truthfully and accurately convey the relevant laws, regulations and technical requirements to the applicant or recorder; (3) Collecting information on adverse medical device events after listing and feeding it back to overseas registrants or applicants, and reporting it to the corresponding food and drug supervision and administration departments; (four) to coordinate the product recall of medical devices after listing, and report to the corresponding food and drug supervision and management departments; (5) Other joint liabilities related to product quality and after-sales service. Fifteenth the applicant or the filing person shall prepare the technical requirements for the medical device products to be registered or filed. The product technical requirements of Class I medical devices shall be submitted to the food and drug supervision and administration department by the filer at the time of filing. The product technical requirements of Class II and Class III medical devices shall be recognized by the food and drug supervision and administration department when approving the registration. The technical requirements of products mainly include the performance indicators and inspection methods of finished medical devices, in which performance indicators refer to the functional and safety indicators of finished products that can be objectively judged and other indicators related to quality control. Medical devices listed in China shall meet the technical requirements of products registered, approved or put on record.
Sixteenth applications for registration of Class II and Class III medical devices shall be subject to registration inspection. Medical device inspection institutions shall register and inspect related products in accordance with product technical requirements. The production of registered inspection samples shall meet the relevant requirements of the quality management system of medical devices, and only those who pass the registration inspection can conduct clinical trials or apply for registration. For the filing of Class I medical devices, the filer may submit the product self-inspection report.
Article 17 To apply for registration inspection, the applicant shall provide relevant technical data, registered inspection samples and product technical requirements to the inspection institution.
Article 18 A medical device inspection institution shall have the qualification of medical device inspection, conduct inspection within its inspection scope, and pre-evaluate the product technical requirements submitted by the applicant. The pre-assessment opinions shall be sent to the applicant together with the registration inspection report. Medical devices that are not included in the scope of medical device inspection institutions shall be inspected by qualified inspection institutions designated by the corresponding registration and examination and approval departments.
Nineteenth products inspected in the same registration unit should be able to represent the safety and effectiveness of other products in the registration unit. Article 20 Clinical evaluation of medical devices refers to the process in which the applicant or applicant confirms whether the product meets the use requirements or scope of application through clinical literature, clinical experience data, clinical trials and other information.
Twenty-first clinical evaluation data refers to the documents formed by the applicant or recorder in clinical evaluation. If clinical trials are needed, the clinical evaluation materials submitted shall include the clinical trial plan and clinical trial report.
Article 22 There is no need to conduct clinical trials for medical devices of Category I for the record. To apply for the registration of Class II and Class III medical devices, clinical trials shall be conducted. Under any of the following circumstances, it may be exempted from clinical trials: (1) The medical devices of the same variety that have been put on the market have been used clinically for many years, and there is no serious adverse events record, and their routine use will not be changed; (2) It can be proved that the medical device is safe and effective through non-clinical evaluation; (3) By analyzing and evaluating the data obtained from clinical trials or clinical use of similar medical devices, it can be proved that the medical devices are safe and effective. The list of medical devices exempted from clinical trials shall be formulated, adjusted and published by China Food and Drug Administration. If the products not listed in the Catalogue of Medical Devices Exempted from Clinical Trials can prove that the medical devices are safe and effective by analyzing and evaluating the data obtained from clinical trials or clinical use of similar medical devices, the applicant may explain them when applying for registration and submit relevant certification materials.
Twenty-third to carry out clinical trials of medical devices should be carried out in qualified clinical trial institutions in accordance with the requirements of the quality management standards for clinical trials of medical devices. The production of clinical trial samples shall meet the relevant requirements of the quality management system of medical devices.
Article 24 Clinical trials of Class III medical devices with high risks to human body shall be approved by China Food and Drug Administration. The third category of medical devices that need to be approved for clinical trials shall be formulated, adjusted and promulgated by China Food and Drug Administration.
Article 25 The examination and approval of clinical trials refers to the process that China Food and Drug Administration comprehensively analyzes the risk degree, clinical trial scheme, clinical benefit and risk comparative analysis report of medical devices to be carried out clinical trials according to the applicant's application, and decides whether to agree to carry out clinical trials.
Twenty-sixth need to carry out the examination and approval of clinical trials of medical devices, the applicant shall submit the application materials to China Food and Drug Administration in accordance with the relevant requirements.
Twenty-seventh China Food and Drug Administration shall, after accepting the application for examination and approval of clinical trials of medical devices, transfer the application materials to the technical evaluation institution of medical devices within 3 working days from the date of accepting the application. The technical review institution shall complete the technical review within 40 working days. China Food and Drug Administration shall make a decision within 20 working days after the technical review. If the clinical trial is approved, an approval document for the clinical trial of medical devices shall be issued; If it is not approved, it shall explain the reasons in writing.
Twenty-eighth in the process of technical evaluation, the applicant needs to be corrected, and the technical evaluation institution shall inform all the contents that need to be corrected at one time. The applicant shall provide supplementary information at one time in accordance with the requirements of the rectification notice within 1 year. The technical review institution shall complete the technical review within 40 working days from the date of receiving the supplementary information. The time for the applicant to supplement the information is not counted in the examination time limit. If the applicant fails to submit supplementary information within the time limit, the technical review institution shall terminate the technical review, put forward a proposal of disapproval, and make a decision of disapproval after approval by China Food and Drug Administration.
Article 29 In any of the following circumstances, China Food and Drug Administration shall revoke the approval documents for clinical trials of medical devices: (1) The application materials for clinical trials are false; (two) the latest research confirmed that the original approved clinical trials have problems in ethics and science; (3) Other circumstances that should be revoked.
Thirtieth clinical trials of medical devices shall be implemented within 3 years after approval; If it is not implemented within the time limit, the original approval document will be automatically abolished, and if clinical trials are still needed, a new application shall be made. Article 31 To apply for medical device registration, the applicant shall submit the application materials to the food and drug supervision and administration department as required.
Article 32 After receiving an application, the food and drug supervision and administration department shall conduct a formal examination of the application materials and deal with them according to the following circumstances: (1) If the application matters fall within the scope of its functions and powers, the application materials are complete and meet the requirements of formal examination, it shall be accepted; (2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; (3) If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be informed of all the contents that need to be corrected at one time within five working days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials; (four) if the application matters do not fall within the scope of authority of the department, it shall immediately inform the applicant that it will not be accepted. When accepting or rejecting an application for registration of medical devices, the food and drug supervision and administration department shall issue a notice of acceptance or rejection stamped with the special seal of the department and dated.
Article 33 The food and drug supervision and administration department that accepts the application for registration shall, within 3 working days from the date of acceptance, forward the application materials to the technical evaluation institution. The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days, and complete the technical review of the registration of Class III medical devices within 90 working days. If external expert review is needed, and the combined products of pharmaceutical machinery need to be jointly reviewed with the drug review agency, the time required shall not be counted, and the technical review agency shall inform the applicant in writing of the time required.
Thirty-fourth food and drug supervision and management departments in the organization of product technical review, can consult the original research data, organize the applicant to check the quality management system related to product development and production. The verification of the registration quality management system of Class II and Class III medical devices in China shall be implemented by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government. The technical evaluation institution of China Food and Drug Administration shall notify the food and drug supervision and administration departments of the corresponding provinces, autonomous regions and municipalities directly under the Central Government for verification, and participate in the verification when necessary. The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall complete the system verification in accordance with relevant requirements within 30 working days. When China Food and Drug Administration's technical review body considers it necessary to verify the quality management system when conducting technical review on imported Class II and Class III medical devices, it shall notify China Food and Drug Administration's quality management system inspection technical body to verify in accordance with relevant requirements, and when necessary, the technical review body shall participate in the verification. The time of quality management system verification is not included in the review time limit.
Thirty-fifth in the process of technical evaluation, the applicant needs to make corrections, and the technical evaluation institution shall inform all the contents that need to be corrected at one time. The applicant shall provide supplementary information at one time in accordance with the requirements of the rectification notice within 1 year; The technical review institution shall complete the technical review within 60 working days from the date of receiving the supplementary information. The time for the applicant to supplement the information is not counted in the examination time limit. If the applicant has any objection to the contents of the Notice of Supplementary Information, he may submit written opinions to the corresponding technical review institution, explain the reasons and provide corresponding technical support materials. If the applicant fails to submit supplementary information within the time limit, the technical review institution shall terminate the technical review, put forward a proposal of not registering, and make a decision of not registering after being approved by the food and drug supervision and administration department.
Article 36 The food and drug supervision and administration department that accepts the application for registration shall make a decision within 20 working days after the end of the technical review. Those that meet the requirements of safety and effectiveness shall be registered, and the medical device registration certificate shall be issued within 10 working days from the date of making the approval decision, and the approved product technical requirements shall be sent to the applicant in the form of attachments. If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for reconsideration and administrative reconsideration or bring an administrative lawsuit according to law. The medical device registration certificate is valid for 5 years.
Article 37 The registered items of medical devices include licensing items and registered items. The licensing items include product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. ; The registered items include the name and domicile of the registrant, the name and domicile of the agent, and the production address of medical devices in China.
Article 38 When approving the registration of medical devices urgently needed for treating rare diseases and responding to public health emergencies, the food and drug supervision and administration department may require the applicant to further complete relevant work after the product is put on the market, and clearly require it in the medical device registration certificate.
Article 39 The food and drug supervision and administration department shall make a decision not to register an accepted application under any of the following circumstances, and inform the applicant: (1) The applicant's research on the safety and effectiveness of medical devices to be listed and its results cannot prove that the products are safe and effective; (2) The application materials for registration are false; (3) The contents of the application materials for registration are confusing and contradictory; (four) the contents of the registration application materials are obviously inconsistent with the application matters; (5) Other circumstances in which registration is not granted.
Article 40 Before making a decision on administrative license, an applicant who has accepted an application for registration may apply to the food and drug supervision and administration department that accepted the application for registration to withdraw the application for registration and related materials, and explain the reasons.
Article 41 The food and drug supervision and administration department may suspend the examination and approval of an accepted application for registration if there is evidence to prove that the application materials for registration may be false. After verification, continue to review or make a decision not to register according to the verification conclusion.
Article 42 If an applicant refuses to accept the decision of the food and drug administration not to register, he may, within 20 working days from the date of receiving the notice of the decision not to register, file an application for review with the food and drug administration that made the licensing decision. The content of the application for review is limited to the original application items and the original application materials.
Article 43 The food and drug supervision and administration department shall make a review decision within 30 working days from the date of accepting the application for review, and notify the applicant in writing. If the original decision is upheld, the food and drug supervision and administration department will no longer accept the applicant's application for re-examination.
Article 44 If an applicant refuses to accept the decision made by the Food and Drug Administration not to register, and has applied for administrative reconsideration or brought an administrative lawsuit, the Food and Drug Administration will not accept his application for reexamination.
Article 45 If the medical device registration certificate is lost, the registrant shall immediately publish a loss statement in the media designated by the original issuing authority. After 1 month from the date of issuing the loss report, apply to the original issuing authority for a replacement, which will reissue it within 20 working days.
Article 46 Where the application for registration of medical devices directly involves the vital interests between the applicant and others, the food and drug supervision and administration department shall inform the applicant and interested parties that they can enjoy the right to apply for a hearing in accordance with laws, regulations and other provisions of China Food and Drug Administration; When examining the application for registration of medical devices, the food and drug supervision and administration department considers that it is a major licensing matter involving public interests, and shall announce it to the public and hold a hearing.
Article 47 For newly developed medical devices that are not listed in the classified catalogue, the applicant may directly apply for product registration of Class III medical devices, or judge the product category according to the classification rules and apply to China Food and Drug Administration for category confirmation before applying for product registration or filing. Directly applying for the registration of Class III medical devices, China Food and Drug Administration shall determine the category according to the degree of risk. If domestic medical devices are classified as Category II, China Food and Drug Administration will forward the application materials to the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the applicant is located for examination and approval; Domestic medical devices belong to the first category, and China Food and Drug Administration will transfer the application materials to the municipal food and drug supervision and administration department located in the district where the applicant is located for the record.
Article 48 Patent disputes arising during and after the examination of registration applications shall be handled in accordance with the provisions of relevant laws and regulations. Article 49 Where the registered Class II and Class III medical devices are changed, the registrant shall apply to the original registration department for registration change and submit the application materials according to the relevant requirements. Where the product name, model, specification, structure and composition, scope of application, product technical requirements and production address of imported medical devices are changed, the registrant shall apply to the original registration department for the change of licensing matters. Where the name and domicile of the registrant and the name and domicile of the agent are changed, the registrant shall apply to the original registration department for changing the registered items; Where the production address of domestic medical devices is changed, the registrant shall change the registered items after the corresponding production license is changed.
Article 50 If the information on the change of registered items meets the requirements, the food and drug supervision and administration department shall issue a document on the change of medical device registration within 10 working days. If the information on the change of registered items is incomplete or does not meet the requirements of formal examination, the food and drug supervision and administration department shall inform all the contents that need to be corrected at one time.
Article 51 For the change of licensed items, technical evaluation institutions should focus on the changed parts and evaluate whether the changed products are safe and effective. The food and drug supervision and administration department that accepts the application for the change of licensing items shall organize technical review in accordance with the time limit stipulated in Chapter V of these Measures.
Fifty-second medical device registration change documents and the original medical device registration certificate are used at the same time, and the validity period is the same as the registration certificate. After obtaining the registration change documents, the registrant shall modify the technical requirements, instructions and labels of the products according to the changes.
Article 53 Where there are no provisions in this chapter on the procedures for acceptance and examination and approval of applications for changes in licensing matters, the relevant provisions in Chapter V of these Measures shall apply. Article 54 If the medical device registration certificate needs to be renewed upon expiration, the registrant shall apply to the food and drug supervision and administration department for renewal of registration six months before the expiration of the medical device registration certificate, and submit the application materials according to the relevant requirements. Except as provided in Article 55 of these Measures, the food and drug supervision and administration department that has received the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed as approval.
Article 55 The registration shall not be renewed under any of the following circumstances: (1) The registrant fails to apply for renewal of registration within the prescribed time limit; (2) The mandatory standards for medical devices have been revised, and the medical devices cannot meet the new requirements; (3) For medical devices that are urgently needed to treat rare diseases and respond to public health emergencies, the examination and approval and registration department put forward requirements when approving the listing, and the registrant failed to complete the items specified in the medical device registration certificate within the prescribed time limit.
Article 56 The procedures for accepting and approving applications for renewal of medical device registration are not specified in this chapter, and the relevant provisions in Chapter V of these Measures shall apply. Article 57 Before the production of Class I medical devices, the products shall be put on record.
Article 58 When filing medical devices, the filer shall submit the filing materials in accordance with Article 9 of the Regulations on the Supervision and Administration of Medical Devices. If the filing materials meet the requirements, the food and drug supervision and administration department shall file the record on the spot; If the filing materials are incomplete or do not conform to the prescribed form, it shall inform all the contents that need to be corrected at one time, and the filing person shall make corrections and file. For the medical devices that have been filed, the food and drug supervision and administration department shall make the filing certificate in the format required by the relevant requirements, and publish the information published in the filing information table on its website.
Article 59 If the contents published in the filing information form and the technical requirements of the products for filing change, the filer shall submit the change explanation and relevant supporting documents, and submit the filing change information to the original filing department. If the filing materials meet the formal requirements, the food and drug supervision and administration department shall announce the changes in the change information and file the filing materials.
Article 60 If the management category of medical devices that have been filed is adjusted, the filer shall take the initiative to propose to the food and drug supervision and administration department to cancel the original filing; If the management category is adjusted to Class II or Class III medical devices, it shall apply for registration in accordance with the provisions of these Measures. Article 61 China Food and Drug Administration shall be responsible for the supervision and administration of the registration and filing of medical devices nationwide, and supervise and guide the registration and filing of medical devices by local food and drug supervision and administration departments.
Article 62 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the registration and filing of medical devices within their respective administrative areas, organize supervision and inspection, and submit relevant information to China Food and Drug Administration in a timely manner.
Article 63 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the principle of territorial management, carry out daily supervision and management over the registration and filing of imported medical devices.
Article 64 The food and drug supervision and administration department at the municipal level divided into districts shall regularly check the filing work and submit relevant information to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government in a timely manner.
Article 65 If a registered medical device should be cancelled according to laws and regulations, or if the registration certificate is invalid but the registrant cancels it voluntarily, the food and drug supervision and administration department shall cancel it according to law and announce it to the public.
Article 66 If the management category of registered medical devices is adjusted from high category to low category, the medical device registration certificate within the validity period will remain valid. If renewal is necessary, the registrant shall apply to the food and drug supervision and administration department for renewal of registration or filing six months before the expiration of the medical device registration certificate according to the changed category. Where the management category of medical devices is adjusted from low category to high category, the registrant shall apply to the food and drug supervision and administration department for registration in accordance with the provisions of Chapter V of these Measures. China Food and Drug Administration shall stipulate the time limit for completing the adjustment in the notice of management category adjustment.
Sixty-seventh provinces, autonomous regions and municipalities directly under the central government food and drug supervision and management departments in violation of the provisions of these measures to implement the registration of medical devices, the China Food and Drug Administration shall order it to make corrections within a time limit; If no correction is made within the time limit, China Food and Drug Administration may directly announce the cancellation of the registration certificate of medical devices.
Article 68 The food and drug supervision and administration department, relevant technical institutions and their staff shall have the obligation to keep confidential the inspection data and technical secrets submitted by the applicant or the applicant. Article 69 Whoever provides false information or obtains the registration certificate of medical devices by other deceptive means shall be punished in accordance with the provisions of the first paragraph of Article 64 of the Regulations on the Supervision and Administration of Medical Devices. Those who provide false information at the time of filing shall be punished in accordance with the second paragraph of Article 65 of the Regulations on the Supervision and Administration of Medical Devices.
Article 70 Whoever forges, alters, buys, sells, rents or lends the registration certificate of medical devices shall be punished in accordance with the second paragraph of Article 64 of the Regulations on the Supervision and Administration of Medical Devices.
Seventy-first in violation of the provisions of these measures, failing to handle the change of the first class medical devices or the change of the registered items of the second and third classes medical devices in accordance with the law, shall be punished in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Seventy-second in violation of the provisions of these measures, the registration license of medical devices has not been changed according to law, and the registration certificate of medical devices has not been obtained in accordance with the regulations on the supervision and administration of medical devices.
Article 73 If the applicant fails to carry out clinical trials in accordance with the Regulations on the Supervision and Administration of Medical Devices and these Measures, the food and drug supervision and administration department at or above the county level shall order it to make corrections and may impose a fine of not more than 30,000 yuan; If the circumstances are serious, the clinical trial shall be stopped immediately, and if the approval document for clinical trial has been obtained, it shall be cancelled. Article 74 A medical device registration or filing unit shall, in principle,
Article 75 The combined components specified in the column "Structure and Composition" of the medical device registration certificate may be sold separately for replacement of consumables, after-sales service and maintenance.
Article 76 The format of medical device registration certificate shall be uniformly formulated by the State Food and Drug Administration. The registration number is × 1 mechanical note× 2××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× In which: × 1 is the abbreviation of the place where the registration examination and approval department is located: the word "country" is used for domestic Class III medical devices, imported Class II and Class III medical devices; The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the central government where the registration and approval departments are located; ×2 is the form of registration: the word "quasi" is applicable to domestic medical devices; The word "gold" is applicable to imported medical devices; The word "Xu" is applicable to medical devices in Hongkong, Macau and Taiwan Province. ××××× 3 is the year of first registration; ×4 is the product management category; ××5 is the product classification code; ××××× 6 is the first registered serial number. Continue to register, keep the number of ××××××× 3 and ×××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× If the product management category is adjusted, it should be renumbered.
Article 77 The numbering method of the filing vouchers for Class I medical devices is × 1 equipment×××××××× 2××××× 3. Where: × 1 is the abbreviation of the place where the filing department is located: the first category of imported medical devices is the word "country"; The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the filing department is located plus the abbreviation of the municipal administrative region (there is no corresponding municipal administrative region with districts, but only the abbreviation of the province, autonomous region and municipality directly under the central government); ××××2 is the year of filing; ×××××× 3 is the serial number for filing.
Article 78 The Measures for the Administration of the Registration of in vitro Diagnostic Reagents under the management of medical devices shall apply to the registration and filing of in vitro diagnostic reagents.
Article 79 Emergency approval procedures for medical devices and special approval procedures for innovative medical devices shall be formulated separately by China Food and Drug Administration.
Article 80 According to the needs of work, China Food and Drug Administration may entrust the food and drug supervision and administration departments or technical institutions of provinces, autonomous regions and municipalities directly under the Central Government and relevant social organizations to undertake specific work related to the registration of medical devices.
Eighty-first medical device product registration fees, fees in accordance with the relevant provisions of the the State Council municipal finance and price departments.
Article 82 These Measures shall be implemented as of 20 14, 10, 1. The Administrative Measures for the Registration of Medical Devices (OrderNo. formerly the State Food and Drug Administration of the United States 16) was promulgated on August 9, 2004 and abolished at the same time.