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Provisions for Medical Device Registration

2019-07-25 15:04:16 20

Provisions for Medical Device Registration

(Decree No. 4 of China Food and Drug Administration)

The Provisions for Medical Device Registration, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.

Minister: Zhang Yong

July 30, 2014

Provisions for Medical Device Registration

Chapter I General Provisions

Article 1 The Provisions is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, with a view to standardizing the administration of medical device registration and filing and guaranteeing the safety and effectiveness of medical devices.

Article 2 All medical devices sold and used within the territory of the People's Republic of China shall apply for registration or filing according to the Provisions.

Article 3 Medical device registration refers to the prescribed procedures conducted by the food and drug regulatory department upon an application submitted by the registration applicant to decide whether the medical device to be marketed can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.

Medical device filing is a process that the filing entity submits the filing documents to the food and drug regulatory department and the food and drug regulatory department files the filing documents submitted by the filing entity.

Article 4 The medical device registration and filing shall be conducted under the principles of publicity, equity and justice.

Article 5 Class I medical device is subject to filing administration and class II and class III medical devices are subject to registration administration.

To apply for filing of class I domestic medical devices, the filing entity shall submit the filing documents to the food and drug regulatory department of the city consisting of districts .

Class II domestic medical devices shall be reviewed by the food and 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 China Food and Drug Administration, 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 China Food and Drug Administration.

Import class II and class III medical devices shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.

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

Article 6 Where a registration applicant or filing entity of a medical device brings the products to the market in his own name, he shall take responsibilities for the product.

Article 7 The food and drug regulatory department shall publicize relevant information on medical device registration and filing promptly in accordance with laws. The applicant can look up the approval progress and relevant results as well as the public can look up the result of approval.

Article 8 The State encourages the research and innovation of medical devices, implements special review for innovative medical devices, accelerates the popularization and application for new technologies of medical devices and promotes the development of medical device industry.

Chapter II Essential Requirements

Article 9 The registration applicant and filling entity of medical devices shall establish a quality management system related to product research, development and manufacture and shall keep its effective operation.

Where applying for registration of a domestic medical device subject to the special review procedures for innovative medical devices and its sample production is entrusted to another enterprise, the applicant shall entrust a medical device manufacturer having corresponding production range. Where the domestic medical device applied for registration is not subject to the special review procedures for innovative medical devices, the sample production shall not be entrusted to another enterprise.

Article 10 The persons undertaking registration or filing for medical devices shall have corresponding specialized knowledge and be familiar with the laws, rules, regulations and technical requirements of the administration on registration or filing of medical devices.

Article 11 When applying for registration or filing, the applicant or filing entity shall complete the research and development of medical devices in accordance with the essential requirements for safety and effectiveness of medical devices and make sure the research and development process is true and standardized and all the data is authentic, complete and traceable.

Article 12 The documents for registration application or filing shall be in Chinese. Where they are translated from another language, the original documents shall also be provided at the same time. When referring to unpublished literature, the applicant shall provide documents proving the owner’s permission to use the information.

The applicant and filing entity shall take full responsibility for the authenticity of the documents submitted.

Article 13 An import medical device being applied for registration shall be one which has already got permission for distribution in the country (region) where the applicant or filing entity is registered or the manufacture is carried out.

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 distribution of sold product in the country (region) where the applicant or filing entity is registered or the manufacture is carried out.

Article 14 An overseas applicant or filing entity shall conduct related work with the support of its representative office established in China or an enterprise legal person in China designated by it as its agent.

The agent shall undertake the following liabilities in addition to conducting medical device registration or filing:

(I) Contacting with corresponding food and drug regulatory department and overseas applicant or filing entity.

(II) Delivering related laws and regulations and technical requirements to the applicant of filing entity in a truthful and faithful manner.

(III) Collecting post-market adverse event information of medical devices and sending feedback to overseas registrants or filing entity, meanwhile, reporting to relevant food and drug regulatory department.

(IV) Coordinating the medical device post-market product recall and reporting to relevant food and drug regulatory department.

(V) Other joint liabilities related to product quality and after-sales service.

Chapter III Product Technical Requirements and Registration Testing

Article 15 The applicant or filing entity shall prepare the product technical requirements for medical device to be registered or filed. The product technical requirements for class I medical devices shall be submitted to the food and drug regulatory department at the time of filing. The product technical requirements for class II and class III medical devices shall be approved by the food and drug regulatory department at the time of registration approval.

Product technical requirements mainly include the performance indicators and testing method of the finished medical device. Performance indicators refer to functional and safety indicators and other quality control indicators of finished medical devices that can be measured objectively.

The medical devices marketed in China shall comply with the product technical requirements which are approved by registration or filed.

Article 16 When applying for class II and class III medical device registration, registration testing shall be conducted. The medical device testing institutions shall carry out relevant registration testing on the products in accordance with the product technical requirements.

The production of samples for registration testing shall comply with relevant requirements of quality management system for medical devices. Clinical trials or registration application can be carried out only after the products passed the registration testing.

For the filing of class I medical device, the filing entity may submit the product self-testing report.

Article 17 For the application of registration testing, the applicant shall submit relevant technical documents and samples for registration testing, and product technical requirements as required according to the registration testing to the testing institutions.

Article 18 Medical device testing institutions shall have the relevant qualification of medical device testing, and perform testing within their specified testing scope. It shall carry out pre-evaluation of the product technical requirements. The pre-evaluation opinions together with the medical device registration testing report shall be submitted to the applicant.

For the medical devices having not included in the testing scope of any medical device testing institutions, the corresponding registration department shall designate a testing institution which has the capability to conduct the testing.

Article 19 The products being tested in one registration unit shall represent the safety and effectiveness for other products in the same registration unit.

Chapter IV Clinical Evaluation

Article 20 Clinical evaluation of medical devices refers to the process that the applicant or filing entity validates whether the products under registration can meet their intended use and indications based on the information of clinical literature, clinical experience data and clinical trials.

Article 21 Clinical evaluation materials refer to the documents developed through clinical evaluation by the applicant or filing entity.

Where clinical trial is required, the clinical evaluation materials to be submitted shall include clinical trial protocol and clinical trial report.

Article 22 For filing of a class I medical device, clinical trial is not required. For application for registration of a class II or class III medical device, clinical trial shall be conducted, however, in one of the following circumstances, clinical trial may be exempted:

(1) Where the functional mechanism of the device is definite, the design is finalized, the production process is well-established, and the marketed medical device of the same variety has been in clinical use for years and no serious adverse events are recorded, and its conventional purposes of use are not changed.

(2) Where safety and effectiveness of the device can be proved through non-clinical evaluation.

(3) Where safety and effectiveness of the medical device can be demonstrated through the analysis and assessment made on the basis of the data obtained from clinical trial or application of a medical device of the same variety.

The catalogue of medical devices that are exempted from clinical trial shall be compiled, adjusted and published by China Food and Drug Administration. Where, for products not listed in the catalogue of medical devices exempted from clinical trial, if the safety and effectiveness of the medical device can be demonstrated through the analysis and evaluation on the data obtained from clinical trials or clinical application of substantially equivalent medical devices, the applicant may give explanations and submit relevant supporting documents when applying for registration.

Article 23 The clinical trial of medical devices shall be conducted within a qualified clinical trial institution according to the requirements of the Good Clinical Practice (GCP) for medical devices. The production of samples used for clinical trial shall meet relevant requirements of quality management system for medical devices.

Article 24 Where the clinical trial of a class III medical device poses high risks to human body, it shall be subject to approval by China Food and Drug Administration. The catalogue of class III medical devices subject to clinical trial approval shall be compiled, adjusted and published by China Food and Drug Administration.

Article 25 The examination and approval of a clinical trial is a process that China Food and Drug Administration conducts a comprehensive analysis to the degree of risk the device may entail, clinical trial protocol, comparative analysis report on clinical benefit and risk of the device to be put on clinical trial, to determine whether to approve the clinical trial.

Article 26 Where a clinical trial approval is required, the applicant shall submit the application documents to China Food and Drug Administration in accordance with related requirements.

Article 27 After accepting the application for approval of clinical trials, China Food and Drug Administration shall forward the application documents to technical evaluation institution within 3 workdays from the date of application acceptance.

The technical evaluation institution shall complete the technical evaluation within 40 workdays and China Food and Drug Administration shall make decisions within 20 workdays after technical evaluation. If the application of clinical trial is approved, the Approval Letter for Clinical Trial of Medical Device shall be issued. If the application is disapproved, the reasons shall be stated in written form.

Article 28 Where supplementary and correction materials are required during technical evaluation, the technical evaluation institution shall inform the applicant one-off of all the supplements to be completed. The applicant shall submit all necessary supplementary and correction materials one-off within one year according to the supplementation notice. The technical evaluation institution shall complete the technical evaluation within 40 workdays from the date of acceptance of the supplements. The time spent by applicant for supplementing such materials shall not be calculated in the overall evaluation time.

Where the applicant fails to submit the supplementary materials within the specified timeline, the technical evaluation institution shall terminate the technical evaluation and come up with a disapproval suggestion, and China Food and Drug Administration shall make a disapproval decision after confirmation.Article 29 In any of the following circumstances, China Food and Drug Administration shall revoke the issued approval document for medical device clinical trials: 

(I) The application materials are spurious.

(II) The latest research confirms that an already approved clinical trial has existing problems in ethicality and scientificalness.

(III) Other circumstances under which an approval document for a medical device clinical trial shall be revoked.

Article 30 Clinical trials of medical devices shall be conducted within 3 years after approval. Where it is not conducted in due time, the original approval document shall be invalid automatically. Where the clinical trial still needs to be conducted, a new application shall be submitted.

Chapter V Product Registration

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

Article 32 The food and drug regulatory department shall conduct preliminary review after accepting an application, and handle respectively according to the following circumstances:

(I) Where the application is within functions and duties of department, and the application materials are complete and meet the preliminary review requirements.

(II) Where the application materials have errors that may be corrected on the spot, the applicant shall be allowed to correct them on the spot.

(III) Where the application materials are incomplete or do not meet the preliminary review requirements, the applicants shall be informed one-off of all the supplements or corrections required within 5 workdays. Where the application is not informed, the application shall be deemed as accepted from the date the application materials are received.

(IV) Where an application is not within the functions and duties of the department, the applicant shall be notified immediately of unacceptance.The food and 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.

Article 33 The food and drug regulatory department accepting the registration application shall forward the application materials to technical evaluation institution within 3 workdays from the date of acceptance.

The technical evaluation institution shall complete the technical evaluation within 60 workdays for class II medical device registration, and within 90 workdays for class III medical device registration.

Where experts shall be invited for an evaluation, or in case of a drug-device combination product, a joint evaluation with the drug evaluation institution is required, the time spent shall not be calculated in the overall evaluation time. The technical evaluation institution shall notify the applicant of the time needed in writing.

Article 34 The food and drug regulatory department may refer to the original research data when organizing a technical evaluation for product registration, and organize an inspection of the applicant's quality management system concerning product research, development and production.

For domestic class II and class III medical device registration, the quality management system shall be inspected by the food and drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government. In case the quality management system inspection is for a domestic class III medical device, the technical evaluation institution of China Food and Drug Administration shall notify the food and drug regulatory department of the corresponding province, autonomous region and municipality directly under the central government to carry out the inspection, and participate in the inspection when necessary. The food and drug regulatory department of the province, autonomous region or municipality directly under the central government shall complete the inspection within 30 workdays according to relevant requirements.

When conducting technical evaluation for an import class II or class III medical device, if the technical evaluation institution of China Food and Drug Administration deems it necessary to conduct a quality management system inspection, it shall notify the technical institution for quality management system inspection of China Food and Drug Administration to carry out the inspection according to relevant requirements. The technical evaluation institution shall participate in the inspection when necessary.

The time for quality management system inspection shall not be calculated in the overall evaluation time.

Article 35 Where supplementary and correction materials are required during technical evaluation, the technical evaluation institution shall inform the applicant one-off of all the supplements to be completed. The applicant shall submit all necessary supplementary and correction materials one-off within one year according to the supplementation notice. The technical evaluation institution shall complete the technical evaluation within 60 workdays from the date of acceptance of the supplements. The time spent by applicant for supplementing such materials shall not be calculated in the overall evaluation time.

Where the applicant has an objection to the content of the notice for supplements or corrections, 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 supplementary materials within the specified timeline, the technical evaluation institution shall terminate the technical evaluation and come up with a disapproval suggestion, and China Food and Drug Administration shall make a disapproval decision after confirmation.

Article 36 The food and drug regulatory department accepting the registration application shall make a decision within 20 workdays after technical evaluation. For that meeting safety and effectiveness requirements, the registration shall be approved, and a medical device registration certificate shall be issued within 10 workdays from the date of approval, 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 a re-evaluation and 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 37 Medical device registration items include permission items and registry items. The permission items include product name, model, specifications, structure and composition, scope of application, product technical requirements, etc., and for an import medical device, production site. The registry items include the name and residence of the registrant, the name and residence of the agent and address of production site of domestic medical devices, etc..

Article 38 For a medical device which is used to treat a rare disease or is urgently needed in dealing with emergent public health incidents, the food and drug regulatory department may require its applicant to further complete relevant work after the product is put on market, and specify the requirements on the medical device registration certificate.

Article 39 For accepted registration applications, where one of the following circumstances exists, the food and 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 and effectiveness of the medical device to be sold on the market.

(II) The registration application materials are spurious.

(III) The registration application materials have confused or inconsistent contents.

(IV) The registration application materials are obviously inconsistent with application items.

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

Article 40 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 food and drug regulatory department which accepted the application.

Article 41 For an accepted registration application, where there are evidences indicating that the registration application materials may be spurious, the food and drug regulatory department shall suspend the evaluation and approval process. After investigation, the food and drug regulatory department shall determine to continue the process or to reject the registration application in accordance with the investigation conclusion.

Article 42 Where an applicant has an objection to the disapproval decision of the food and drug regulatory department, it may submit a re-evaluation application within 20 workdays after receiving the disapproval notice to the food and drug regulatory department that made the decision. Contents of the re-evaluation application shall be limited to original application items and original application materials.

Article 43 The food and drug regulatory department shall make a re-evaluation decision within 30 workdays after accepting the re-evaluation application and inform the applicant. Where the original decision shall be maintained, the food and drug regulatory department shall not accept further application for re-evaluation by the applicant.

Article 44 Where the applicant has an objection to the disapproval decision of the food and drug regulatory department, and has applied for an administrative reconsideration or administrative litigation, the food and drug regulatory department shall not accept its re-evaluation application.

Article 45 Where a medical device registration certificate is lost, the registrant shall publish a loss declaration immediately at the media specified by the original certificate-issuing authority, and apply after 1 month of declaration to the original certificate-issuing authority for re-issuing the certificate. The original certificate-issuing authority shall re-grant the medical device registration certificate within 20 workdays.

Article 46 Where major interest relationship between the applicant and others is directly involved in the application for medical device registration, the food and drug regulatory department shall inform the applicant and the interested party of their right to apply for a hearing in accordance with laws, regulations and other provisions of China Food and Drug Administration. During the process of reviewing the application for medical device registration, if the food and drug regulatory department believes there are major licensing issues concerning public interests, it shall make a public announcement and hold a hearing.

Article 47 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 China Food and Drug Administration for a class confirmation, and apply for product registration or for filing thereafter.

Where a class III medical device registration is directly applied for, China Food and Drug Administration shall determine the class according to its risk degree. Where a domestic medical device is determined as class II, China Food and Drug Administration shall forward the application materials to the food and drug regulatory department of the province, autonomous region or municipality directly under the central government where the applicant is located, for evaluation and approval. Where a medical device is determined as class I, China Food and Drug Administration shall forward the application materials to the food and drug regulatory department of the city consists of its districts where the applicant is located, for filing.

Article 48 Where a patent dispute arises during the registration review or after approval, it shall be dealt with according to relevant laws and regulations.

Chapter VI Registration Alteration

Article 49 For a registered class II or class III medical device, if the content of the medical device registration certificate and its attachment(s) has an alteration, the registrant shall apply to the original registration department for registration alteration and submit application materials according to relevant requirements.

Where the alteration is for product name, model, specifications, structure and components, scope of application, product technical requirement, etc., and for an import medical device, production address, the registrant shall apply to the original registration department for change of permission items.

Where the alteration is for name, residence of the applicant and the agent, the registrant shall apply to the original registration department for change of registry items. Where the alteration is for production address of a domestic medical device, the registrant shall apply for change of registry items after the corresponding production license is changed.

Article 50 Where the application documents for change of registry items conform to the requirements, the food and drug regulatory department shall issue the medical device registration alteration document within 10 workdays. Where the application documents are not complete or do not meet the requirements for preliminary review, the food and drug regulatory department shall inform the applicant all the documents needed to be supplemented and corrected.

Article 51 For change of permission items, the technical evaluation institution shall focus on evaluating the changed parts and give comments on product safety and effectiveness after the change.

The food and drug regulatory department accepting the application for change of permission items shall organize technical evaluation within the period specified in Chapter V of the Provisions.

Article 52 The medical device registration alteration document shall be used in conjunction with the original medical device registration certificate and its period of validity shall be the same with that of the original registration certificate. After obtaining the registration alteration document, the registrant shall alter the product technical requirements, instructions and labels by himself.

Article 53 Where provisions concerning acceptance and approval procedures of the application for change of permission items are not available in this chapter, Chapter V of the Provisions shall prevail.

Chapter VII Registration Renewal

Article 54 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 food and drug regulatory department six months before the expiration of period of validity and submit application documents according to corresponding requirements.

Except for the situations specified in Article 55, the food and 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 55 The registration renewal shall not be approved in any of the following circumstances:

(I) The registrant fails to submit the application for registration renewal within the specified period.

(II) The mandatory standard(s) of the medical device has been revised, and the medical device fails to meet the requirements of the new standard(s). 

(III) For a medical device which is used to treat a rare disease or is urgently needed in dealing with emergent public health incidents, the registrant fails to complete items stated in medical device registration certificate within specified time as required by registration department upon approving such registration.

Article 56 Where provisions concerning acceptance and approval procedures of application for registration renewal of medical device are not available in this chapter, Chapter V of the Provisions shall prevail.

Chapter VIII Product Filing

Article 57 Filing for a class I medical device shall be conducted prior to production.

Article 58 For a medical device filing, the filing entity shall submit the filing documents in accordance with Article 9 of the Regulations on Supervision and Administration of Medical Devices.

Where the filing documents meet the requirements, the food and drug regulatory department shall complete the filing on the spot. Where the filing documents are not complete or do not meet the filing requirements, the filing entity shall be informed of all the supplements and corrections to be made one- off, for filing after supplements and corrections.

For a filed medical device, the food and drug regulatory department shall make filing certificates according to the format in relevant requirements and publish the information from the filing information form for medical device on their website.

Article 59 For a filed medical device, where the contents set forth in the filing information form for medical device changed, the filing entity shall submit a description of the change and related supporting documents to the original filing department and apply for change of filing. Where the filing documents meet the format requirements, the food and drug regulatory department shall put the changes in the information of changes, and file a record.

Article 60 Where the management classification of a filed medical device is adjusted, the filing entity shall apply to the food and drug regulatory department for cancellation of the original filing. Where the management classification is adjusted to a class II or class III medical device, the filing entity shall apply for registration in accordance with the Provisions.

Chapter IX Supervision and Administration

Article 61 China Food and Drug Administration shall be responsible for the supervision and administration of medical device registration and filing nationwide, and supervise and guide the medical device registration and filing by local food and drug regulatory departments.

Article 62 The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and administration of medical device registration and filing within their administrative areas, and organize supervision and inspection and report relevant situations to China Food and Drug Administration.

Article 63 The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall, in accordance with the principle of territorial administration, perform routine supervision and administration over the work concerning registration and filing done by agents for import medical devices.

Article 64 The food and drug regulatory departments of the cities consisting of districts shall perform regular examination over the filing of medical devices and timely report relevant information to the food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government.

Article 65 Where, for a registered medical device, there exists a revocation situation in accordance with laws and regulations, or a registrant applies for revocation before the expiration of a registration certificate, the food and drug regulatory department shall revoke the registration certificate according to law and disclose to the society.

Article 66 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 changed classification to corresponding food and drug regulatory department six months prior to the expiration of period of validity of the registration certificate.

Where, the medical device classification is adjusted from a lower class to a higher one, the registrant shall apply for registration on changed classification to the corresponding food and drug regulatory department in accordance with the provisions in Chapter V hereof. China Food and Drug Administration shall specify a time limit for completing the adjustment in the notice on adjusting management classification.

Article 67 Where a food and drug regulatory department of a province, autonomous region or municipality directly under the central government conducts a medical device registration by violating the Provisions, China Food and Drug Administration shall order it to correct within a deadline. Where it fails to correct before the deadline, China Food and Drug Administration may directly announce a revocation of the medical device registration certificate.

Article 68 The food and drug regulatory departments, relevant technical institutions and their staff shall be liable for the confidentiality of all the trial or testing data and know-how submitted by the applicant or filing entity.

Chapter X Legal Responsibilities

Article 69 Where a medical device registration certificate is obtained by providing spurious documents or by other deception means, punishments shall be imposed according to Paragraph 1, Article 64 of the Regulations on Supervision and Administration of Medical Devices.

Where a filing is done by providing spurious documents, punishments shall be imposed according to Paragraph 2, Article 65 of the Regulations on Supervision and Administration of Medical Devices.

Article 70 Where a medical device registration certificate is falsified, altered, bought or sold, leased or lent, punishments shall be made according to Paragraph 2, Article 64 of the Regulations on Supervision and Administration of Medical Devices.

Article 71 Where, in violation of the Provisions, a change of filing for a class I medical device is not performed, or a registration alteration of registry items for a class II or class III medical device is not performed according to law, punishments shall be imposed according to the situation concerning fail in filing in the Regulations on Supervision and Administration of Medical Devices.

Article 72 Where, in violation of the Provisions, a registration alteration of permission items for a medical device is not performed according to law, punishments shall be imposed according to the situation concerning not obtaining a medical device registration certificate in the Regulations on Supervision and Administration of Medical Devices.

Article 73 Where a clinical trial performed by an applicant is not in accordance with the Regulations on Supervision and Administration of Medical Devices and the Provisions, the food and drug regulatory department at or above the county level shall order for rectifications and may impose a penalty of less than 30,000 yuan(RMB). In case of severe conditions, the clinical trial shall be stopped immediately. Where a clinical trial approval document is already obtained, it shall be cancelled.

Chapter XI Supplementary Provisions

Article 74 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 75 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 76 The format of the medical device registration certificate shall be prepared by China Food and Drug Administration.

The registration number shall be arranged in the following form:

×1 XZ ×2××××3×4××5××××6. Among which,

×1 shall be the abbreviation of the place where the registration department is located.

The letter "G" 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.

“Z” is applicable to domestic medical devices.

“J” is applicable to import medical devices.

“X” is applicable to medical devices from Hong Kong, Macao and Taiwan.

××××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 77 The filing certificate for class I medical device shall be arranged in the following form:

×1 XB××××2××××3. Among which,

×1 shall be the abbreviation of the place where the filing department is located.

The letter "G" 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 78 The Provisions for In-Vitro Diagnostic Reagent Registration shall be applicable to the registration and filing of in-vitro diagnostic reagents administered as medical devices.

Article 79 The emergency approval procedure for medical devices and the special approval procedure for innovative medical devices shall be separately formulated by China Food and Drug Administration.

Article 80 China Food and Drug Administration may, according to necessity, authorize the food and 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 related to the registration of medical devices.

Article 81 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 82 The Provisions shall be effective as of October 1, 2014. The Provisions for Medical Device Registration promulgated on August 9, 2004 (Decree No. 16 of the former State Food and Drug Administration) is annulled simultaneously.