Provisions for IVD Registration

Chapter 1 General Provisions

Article 1 The present Provisions are formulated in accordance with the Regulations for Supervision and Administration of Medical Devices in order to regulate the registration and filing administration of IVD reagents, and ensure the safety & effectiveness.

Article 2 Where any IVD reagent is sold or used within the territory of the People’s Republic of China, it shall apply for the registration or handle the filing in accordance with the provisions of the present Provisions.

Article 3 For the purpose of the present Provisions, the term IVD Reagents mentioned herein shall mean IVD reagents administrated as medical devices, including reagents, reagent kits, calibrators, controls and other products used for detection in vitro of human body sample in the courses of disease prediction, prevention, diagnosis, treatment & monitoring, prognostic observation and health status assessment, which may be used separately or in combination with instruments, appliances, devices or systems.   
IVD reagents administrated as drugs and used for blood donor screening as well as those marked with radionuclide shall not belong to the scope of administration hereof.

Article 4 Registration of IVD Reagents shall mean the process during which the food and drug regulatory authority will carry out a systematic assessment on safety, effectiveness study of IVD reagents proposed to be listed as well as results thereof pursuant to the application of the applicant in accordance with legal procedures to decide if it approves the foresaid application.
Filing of IVD Reagents shall mean that the filing applicant submits relevant data to the food and drug regulatory authority, and the food and drug regulatory authority keeps such filing data submitted on file for reference.

Article 5 The registration and filing of IVD reagents shall comply with the principles of openness, fairness and impartiality.

Article 6 Class Ⅰ IVD reagent shall be applicable to the administration by filing, while Class Ⅱ, Ⅲ IVD reagent shall be applicable to that by registration.
As for the filing of domestic Class Ⅰ IVD reagent, the filing applicant will submit relevant filing data to the food and drug regulatory authority at city level where it is divided into districts.
As for domestic Class Ⅱ IVD reagent, The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government will review the foresaid reagent, and issue a registration certificate of medical device upon approval. 
As for domestic Class Ⅲ IVD reagent, CFDA will review the foresaid reagent, and issue a registration certificate of medical device upon approval.
As for the filing of imported Class Ⅰ IVD reagent, the filing applicant will submit relevant filing data to CFDA. 
As for imported Class Ⅱ, Ⅲ IVD reagent, CFDA will review the foresaid reagent, and issue a registration certificate of medical device upon approval.
The registration, filing of IVD reagents at regions of Hong Kong, Macao and Taiwan shall be handled in reference to the import thereof.

Article 7 Where IVD reagent applicant or filing applicant promotes the product to the market in its own name, it shall be liable thereto.

Article 8 The food and drug regulatory authority shall promptly announce the information related to registration, filing of IVD reagents according to the laws. The applicant may have access to approval progress and results, and the approval results may be made available to the public.

Article 9 China encourages research and innovation of IVD reagents, provides preferential approval on innovative IVD reagents in order to facilitate promotion and application on new technology of IVD reagents, and promote the development of medical device industry.

Chapter 2 Basic Requirements

Article 10 IVD reagent registration applicants and filing applicants shall establish a quality management system related to product development, manufacture, and maintain it in an efficient operation. 
At time of application for registration of domestic IVD reagent approved in accordance with preferential approval procedures of innovative medical device, in case its sample is to be produced by other enterprise, it shall entrust the enterprise having qualification in manufacture of medical devices; at time of application for registration of domestic IVD reagent other than approved in accordance with preferential approval procedures of innovative medical device, its sample shall not be produced by any other enterprise.  

Article 11 The personnel responsible for registration or filing of IVD reagents shall have the corresponding professional knowledge, be familiar with laws, regulations, rules and technical requirements related to administration of medical device registration or filing.

Article 12 The product development of IVD reagents includes selection & preparation of main raw materials, determination of product manufacturing technology, formulation of product technical requirements, product stability study, fixation of cut-off value or reference interval, as well as product analysis performance evaluation, clinical evaluation and other related work.  
The applicant or filing applicant may refer to relevant technical guiding principles for product development, and may also adopt different experimental methods or technical means, but shall explain the justification thereof.  

Article 13 Where the applicant or filing applicant applies for the registration or handle the filing formalities, it shall comply with the requirements on safety and effectiveness of IVD reagents, and guarantee standardized development process as well as true, complete and traceable data.

Article 14 The data on application for registration or filing shall be made in Chinese. In case of any translation pursuant to foreign language materials, the original text shall be provided together with such translation. Any reference to documentary data not published to the public shall be furnished with supporting documents stating the data owner is licensed.
The applicant or filing applicant is liable to authenticity of the foresaid data.

Article 15 The imported IVD reagents in application for registration or in filing formalities shall have been approved to be listing and sale at the place where the applicant or filing applicant is registered or at the country (region) where the manufacture site is located.
If the place where the applicant or filing applicant is not registered or the country (region) where the manufacture site is located fails to administer such product as medical device, the applicant or filing applicant is required to provide relevant supporting documents, including supporting documents proving the place of registration or the country (region) where manufacture site is located allows the foresaid listing and sale of such product.

Article 16 Overseas applicant or filing applicant shall establish its representative office within the territory of China or designate an enterprise within the territory of China as its agent to coordinate it in relevant work.
The agency shall assume the following responsibilities in addition to registration or filing of IVD reagents:
(Ⅰ) Keep contact with corresponding  food and drug regulatory authority, overseas applicant or filing applicant;
(Ⅱ) Deliver relevant regulations and technical requirements to the applicant or filing applicant faithfully and accurately;
(Ⅲ) Collect the information on adverse event of IVD reagents after the listing and give feedbacks to overseas applicant or filing applicant, and report to corresponding  food and drug regulatory authority; 
(Ⅳ) Coordinate in product recall work of IVD reagents after the listing, and report to corresponding  food and drug regulatory authority;
(Ⅴ) Assume joint and several liability otherwise involved in product quality and after-sales service.

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Chapter 3 Product Classification and Designation

Article 17 IVD reagents are classified into Class Ⅰ, Ⅱ and Ⅲ according to product risk classification from low to high.
(Ⅰ) Class Ⅰ
1. Microbial media (not applicable to microorganism identification and drug sensitivity test);
2. Products for sample processing, e.g. hemolytic agent, diluents, staining solution, etc.   
(Ⅱ) Class Ⅱ
Except defined specially as Class Ⅰ and Ⅲ,  the products belong to Class Ⅱ, mainly including:
1. Reagent used for protein detection;
2. Reagent used for hydrocarbon detection;
3. Reagent used for hormone detection;
4. Reagent used for enzyme detection;
5. Reagent used for ester detection;
6. Reagent used for vitamin detection;
7. Reagent used for inorganic ion detection;
8. Reagent used for detection of drugs and drug metabolites;
9. Reagent used for autoantibody detection;
10. Reagent used for microorganism identification and drug sensitivity test;
11. Reagent used for detection of other physiological, biochemical or immune function index;
(Ⅲ) Class Ⅲ
1. Reagent related to pathogenic pathogen antigen, antibody, nucleic acid and otherwise detection; 
2. Reagent related to blood type, tissue matching; 
3. Reagent related to human gene detection;
4. Reagent related to hereditary diseases;
5. Reagent related to detection of narcotics, psychotropic drugs, toxic drugs for medical use;
6. Reagent related to detection of therapeutic drug target;
7. Reagent related to detection of tumor marker;
8. Reagent related to allergy (allergen).

Article 18 If Class Ⅱ listed in Article 17 is used for tumor diagnosis, assisted diagnosis, therapeutic process monitoring, or used for hereditary disease diagnosis, assisted diagnosis, etc., it shall be registered and administered as Class Ⅲ. Where the reagent used for detection of drugs and drug metabolites belongs to narcotics, psychotropic drugs or toxic drugs for medical use, it shall be registered and administered as Class Ⅲ.

Article 19 The calibrator, controls may apply for registration in combination with the matching IVD reagents or separately.
The calibrator, controls used with Class Ⅰ IVD reagent may be registered as Class Ⅱ; when the calibrator, controls used with Class Ⅱ, Ⅲ IVD reagent applies for registration separately, it shall be registered according to the same Class as the reagent; several calibrators, controls shall be registered by higher Class.

Article 20 CFDA is responsible for preparation and adjustment on a classified product catalogue of IVD reagents. 
As for IVD reagents newly developed but not listed into the classification catalog of IVD reagents, the applicant may directly apply for registration of Class Ⅲ IVD reagent, or may judge product Class pursuant to classification rules and apply Classification to CFDA and then apply for the product registration or handle the filing. 
In case of direct application for registration of Class Ⅲ IVD reagent, CFDA will determine the Classification according to risk degrees. Where domestic IVD reagent is determined as Class Ⅱ, CFDA will transfer the application data to The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government where the applicant is located for evaluation and approval; where domestic IVD reagent is determined as Class Ⅰ, CFDA will transfer the application data to the food and drug regulatory authority at city level where the applicant is located for filing.  

Article 21 The designation of IVD reagents shall comply with the following principles:
The product name of IVD reagents shall generally be composed of three parts: the first part is the name of substance tested; the second part is the purpose, e.g. serum diagnosis, determination of reagent kit, controls, etc.; the third part is the method or principle, e.g. ELISA, colloidal gold method, etc., which shall be listed in the brackets. 
If the substance tested has many components or other special circumstance, it may adopt the indication name related to the product or other substituted name.  
Class Ⅰ IVD reagent, calibrator and controls may be named according to their intended purpose. 
 

Chapter 4 Product Technical Requirements and Registration Testing

Article 22 Under condition of raw material quality and manufacture technology stability, the applicant or filing applicant shall propose product technical requirements according to product development, clinical evaluation and other results in accordance with national standards, industrial standards and relevant literatures.   
The product technical requirements mainly include performance requirements and test methods of finished product of IVD reagents, in which Performance requirements shall mean functionality, safety requirements objectively judged for finished product as well as other requirements related to quality control.
The technical requirements of Class Ⅲ IVD reagent shall define main raw materials, manufacturing  technology and semi-finished product requirements in form of the appendix. 
The technical requirements of Class Ⅰ IVD reagent will be submitted by the filing applicant to the food and drug regulatory authority at time of filing, and those of Class Ⅱ, Ⅲ IVD reagent will be verified by the food and drug regulatory authority at approval for registration.
The IVD reagents listed in China shall comply with the product technical requirements registered and verified or filed.

Article 23 If any application of Class Ⅱ, Ⅲ IVD reagent for registration is carried out, it shall carry out Registration Testing; Class Ⅲ IVD reagent shall be subject to the Registration Testing of the samples in successive 3 manufacture batches. The Medical Device Testing Institution shall test relevant product according to the product technical requirements.
The manufacture of registered tested sample shall comply with the requirements related to medical device quality management system, and the clinical trial or application for registration may be carried out only upon qualified Registration Testing. 
Where any filing of Class Ⅰ IVD reagent is handled, the filing applicant may submit the self-test report of the product.

Article 24 Where the Registration Testing is applied, the applicant shall provide the Testing Institution with relevant technical data, sample for Registration Testing, product technical requirements and standard or reference material required for Registration Testing.   
The sample of domestic applicant for Registration Testing will be taken by the food and drug regulatory authority.

Article 25 Where the product is applicable to national standard or reference material, the Registration Testing shall be conducted according to standard or reference material. The National Institutes for Food and Drug Control is responsible for preparation and calibration of national standard or reference material.

Article 26 The Medical Device Testing Institution shall have medical device inspection qualification and carry out the test within its test scope, and conduct pre-assessment on product technical requirements submitted by the applicant. The pre-assessment opinions will be issued to the applicant along with Registration Testing report.  
The product not listed into the test scope of Medical Device Testing Institution will be tested by a competent testing institution designated by the corresponding registration approval department.

Article 27 When the sample application for registration includes different packing specifications, the product in a single packing specification may be subject to the Registration Testing.

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Chapter 5 Clinical Evaluation

Article 28 Clinical Evaluation of IVD Reagents shall mean the process during which the applicant or filing applicant confirms if the product will satisfy application requirements or intended purpose through clinical literatures, clinical trial data, clinical trial and other information.

Article 29 Clinical Evaluation Documents shall mean the documents formed by the applicant or filing applicant for clinical evaluation.
Clinical Trial of IVD Reagents (including comparative research trial conducted for listed product) shall mean the systematic research carried out for clinical performance of IVD reagents in corresponding clinical environment.  
As for IVD reagents without clinical trial, the applicant or filing applicant shall assess clinical performance of IVD reagents through evaluation of clinical samples covering intended purpose and interference factor, integrated literatures or other non-clinical trial means. The applicant or filing applicant shall guarantee traceability of clinical samples used for evaluation. 

Article 30 If any filing of Class Ⅰ IVD reagent is handled, the clinical trial is not required. If any application of Class Ⅱ, Ⅲ IVD reagent for registration is carried out, the clinical trial shall be carried out.
Under any of the following circumstances, the clinical trial may be exempted:
(Ⅰ) With definite reaction principle, established design and mature manufacture technology, the listed IVD reagent in same variety has been applied in clinical respect for many years without serious adverse event, free from alteration of general purpose, and the applicant can provide evaluation data related to equivalence of the listed product;   
(Ⅱ) The safety, effectiveness of IVD reagent can be proved through evaluation of clinical samples covering intended purpose and inference factor. 
The list of IVD reagents which are exempt from clinical trial will be formulated, adjusted and promulgated by CFDA.

Article 31 When the sample application for registration includes different packing specifications, the sample in a single packing specification may be subject to the clinical evaluation.

Article 32 The applicant of Class Ⅲ shall select no less than 3 (inclusive), and the applicant of Class Ⅱ shall select no less than 2 (inclusive) qualified clinical trial institutions to carry out clinical trials in accordance with relevant regulations. The manufacture of clinical trial sample shall comply with the requirements related to medical device quality management system.  

Article 33 The applicant shall enter into a clinical trial contract with the clinical trial institution, formulate and improve clinical trial schemes in reference to relevant technical guiding principles, provide the samples for clinical trial free of charge, and assume clinical trial expenses.

Article 34 The number of clinical trial cases shall be determined according to clinical trial target, statistical requirements and in reference to relevant technical guiding principles. The technical guidances of clinical trial are to be published separately. 
Where any IVD reagent used for rare diseases and emergent public health event requires the decrease on the number of clinical trial cases or the exemption from clinical trials, the applicant shall apply for exemption from clinical trials and explain reasons in details at submission of registration application data. If any additional clinical trial is required upon determination of the Technical Evaluation Institution under the food and drug regulatory authority through overall technical evaluation on registration application data, it shall be notified to the applicant in form of the supplementary data.

Article 35 If any application of imported IVD reagent for registration is carried out, overseas clinical evaluation data shall be provided. The applicant shall carry out the pointed clinical evaluation within the territory of China pursuant to the requirements of clinical evaluation considering epidemiological background in different countries or regions, characteristics of different disease categories, cut-off value or reference interval applicable to different species, etc. 

Article 36 Upon clinical trials completed of clinical trials, the clinical trial institution shall issue the clinical trial reports respectively. The applicant or clinical trial leading unit shall summarize clinical trial results and complete the clinical trial summary report according to relevant technical guiding principles.  

Article 37 During clinical trial, any IVD reagent used individually by the consumers shall contain the evaluations on cognitive ability of product specifications made by the consumers without medical background. 

Article 38 Where the applicant discovers clinical trial institution violates relevant provisions or fails to perform clinical trial schemes, the applicant shall urge such institution to correct the foresaid problem; and if the circumstance is serious, the applicant may request to suspend or terminate clinical trials, and report to CFDA and The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government where the clinical trial institution is located.

Article 39 Where any institution and personnel participating in clinical trials requests to alter trial data or conclusion for the applicant’s violation of relevant provisions, it shall report to CFDA and The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government where the applicant is located.

Article 40 If any clinical trial of IVD reagents is conducted, it shall be reported to The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government where the applicant is located for filing. The food and drug regulatory authority accepting the filing shall announce the filing conditions to the food and drug regulatory authority and the Health & Family Planning Department at same level where the clinical trial institution is located.
CFDA and The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government will carry out supervision and check on implementation of clinical trials according to the needs.

Chapter 6 Product Registration

Article 41 As for application of IVD reagents for registration, the applicant shall report and submit application data to the food and drug regulatory authority in accordance with relevant requirements.

Article 42 The food and drug regulatory authority will carry out formal examination on application data upon receipt of the application, and handle it pursuant to the following situations respectively:
(Ⅰ) Where the application belongs to the terms of reference of this Department and the application documents are qualified in compliance with formal examination requirements, the food and drug regulatory authority may accept the application; 
(Ⅱ) Where the application data has any error which may be corrected on spot, the food and drug regulatory authority shall allow the applicant to correct the error on spot;
(Ⅲ) Where the application data is incomplete or not qualified to comply with formal examination requirements, the food and drug regulatory authority shall inform the applicant of all contents to be supplemented within 5 working days just for once, and if it fails to overdue, it shall be deemed as acceptance upon the date of receipt of application data.
(Ⅳ) Where the application is beyond the terms of reference of this Department, it shall immediately notify the applicant not to accept the application. 
As for acceptance or rejection of registration application for IVD reagents, the food and drug regulatory authority shall issue the dated notice on acceptance or rejection affixed with special seal for this Department.  

Article 43 The food and drug regulatory authority under acceptance of registration application shall deliver the application documents to the Technical Evaluation Institution within 3 working days since the date of acceptance. 
The Technical Evaluation Institution shall finish technical evaluation of Class Ⅱ IVD reagent registration within 60 working days, and finish that of Class Ⅲ IVD reagent registration within 90 working days.  
Where it is required to employ external experts for evaluation, the time spent is excluded, and the Technical Evaluation Institution shall inform the applicant of the time spent in writing.  

Article 44 The food and drug regulatory authority may have access to original research materials at organization of product technical evaluation, and organize the inspection of quality management system related to product development, manufacture for the applicant. 
The quality management system of domestic Class Ⅱ, Ⅲ medical device registration will be inspected by The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government, in which, the quality management system of domestic Class Ⅲ medical device registration will be notified by the Technical Evaluation Institution under CFDA to the food and drug regulatory authority at corresponding provincial, autonomous regional, municipal level for inspection, and if necessary, participate in the inspection. The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government shall finish the system inspection within 30 working days in accordance with relevant requirements.
When the Technical Evaluation Institution under CFDA deems it is necessary to inspect the quality management system at technical evaluation on imported Class Ⅱ, Ⅲ IVD reagent, it shall notify the Technical Institution of Quality Management System Inspection under CFDA to conduct the inspection according to relevant requirements, and if necessary, the Technical Evaluation Institution may participate in the inspection.   
The inspection time of quality management system is not incorporated into evaluation time limit.

Article 45 The Technical Evaluation Institution shall inform of the applicant who needs supplement and correct the materials during evaluation, to supplement and correct all materials just for once. The applicant shall submit the supplemental materials just for once within one year in accordance with the supplement notice; the Technical Evaluation Institution shall accomplish the evaluation within 60 working days as of the date of receiving the supplemental materials. Time taken for supplementing materials by the applicant is not counted in the time limit of evaluation.

If the applicant has any objection to the supplemented and corrected materials, they can submit suggestions to the corresponding Technical Evaluation Institution in writing illustrating justifications and providing corresponding technical supporting materials.

If the applicant fails to submit supplemental materials beyond time limit, the Technical Evaluation Institution reserves rights to terminate the evaluation and give suggestion that “the applicant shall not be registered” and the food and drug regulatory authority will verify and make decision that “he applicant shall not be registered” after verification.

Article 46 The food and drug regulatory authority responsible for acceptance of registration and application shall make decisions within 20 working days as of the date of making approval decision. Grant registration to the application in accordance with safe and effective requirements and the registration certificate of medical device will be issued within 10 working days after making decision of evaluation. Product technical requirements and product instructions passing through review are sent to the applicant in attachments. Where the registration is not granted, state justifications in writing and inform the applicant of reserving the rights to apply for review, administrative reconsideration or charging administrative litigation.

Validity period of registration certificate of medical device is 5 years.

Article 47 IVD reagents registration items include approval and administrative items. Approval item includes product name, main components, intended use, product technical requirements, package insert, product stability, manufacturing address of imported IVD reagents etc.; administrative items includes names and residences of registration applicant, agency and  domestic IVD reagents manufacture address etc.

Article 48 Where IVD reagents that rare disease and emergency public sanitation event treatments need urgently, the food and drug regulatory authority can request the applicant to make further relevant work after the product launching onto market and to state illustration in registration certificate of medical device when registration of IVD reagents is granted.

Article 49 As for the accepted registration application, the food and drug regulatory authority makes decision not to register and notify the applicant if any one of the following situations existing:

(1) The applicant cannot approve the safety and effectiveness of products research and its result of safety and effectiveness of IVD reagents planning to launch onto market.

 (2) Fake registration and application documents;

(3) Confusing and inconsistent registration application documents ;

(4) Contents of application materials for registration does not comply with application item obviously;

(5) Other situations that do not allow registration.

Article 50 As for the accepted application for registration, the applicant can apply for withdrawing application for registration and relevant materials and illustrate to the food and drug regulatory authority before administrative license has been made.

Article 51 As for application for registration that have been accepted, the food and drug regulatory authority can terminate evaluation if there is any evidence indicating that application documents for registration may be fake. After verification, continue to evaluate or do not allow registration basing on verification conclusion.

Article 52 If the applicant has any objection to none registration decision made by the food and drug regulatory authority, he can apply for re-evaluation within 20 working days as of the date of receiving none registration notice to the food and drug regulatory authority making evaluation decision. Contents of re-evaluate application are only limited to the original application items and documents.

The food and drug regulatory authority shall make re-evaluation decision within 30 working days as of the date of accepting re-evaluation application and notify the applicant in writing. , Where the original decision has been maintained, the food and drug regulatory authority will not accept re-evaluation application from the applicant again.

Article 53 If the applicant has any objection to none registration decision made by the food and drug regulatory authority and he has applied for administrative reconsideration or charged administrative litigation, the food and drug regulatory authority will not accept its re-evaluation application.

Article 54 As for loss of registration certificate of medical device, the applicant shall publish loss declaration on media appointed by original issuing authority at once. After one full month as of the date of publishing loss declaration, the applicant applies for reissue to original issuing authority, reissue shall be issued within 20 working days thereof.

Article 55 After IVD reagents launching onto market, its technical requirements and package insert shall comply with contents approved by the food and drug regulatory authority. The applicant or filing applicant shall keep track of safety and effectiveness of products launching onto market and submit change application of technical requirement and instruction of products if necessary.

Article 56 When the IVD reagents application involves with vital interest between the applicant and others directly, the food and drug regulatory authority shall notify applicant and the interested party who reserves the right to apply for hearing in accordance with lawsuit, regulations and relevant provisions of CFDA; when evaluate registration application of IVD reagents, the food and drug regulatory authority shall announce to the public and hold hearing for vital items involving in public interests thereof.

Article 57 As for any patent dispute existing during registration application and after approval, handle it in accordance with provisions in relevant laws and regulations

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Chapter 7 Change Registration

Article 58  The applicant shall apply for change registration to original registration department and submit application documents in accordance with relevant requirements whenever there is any content change in registration certificate and its attachment on registered Class II, III IVD reagents.

The applicant shall apply for Change of Administrative Matters to original registration department whenever there is any change in name and address of applicant and agent; the applicant shall perform Change of Administrative Matters after finishing corresponding manufacturing approval change whenever there is any change of manufacturing address in domestic IVD reagents.

Where there is any following content changes in registration certificate and attachment, the applicant shall apply for license item alteration to original registration department:

(1) Alteration in antigen, antibody etc. main materials supplier;

(2) Alteration in testing condition, cut-off value or reference interval;

(3) Alteration in item, requirements and testing method set up in technical requirements of registration product;

(4) Alteration in package specifications and applicable model;

(5) Alteration in storage condition or product stability;

(6)Adding intended use, such as adding clinical indication, adding sample type in clinical testing;

(7) Manufacture address alteration of imported IVD reagents;

(8) Other alterations may affect safety and effectiveness of products.

Article 59 The following situations that do not belong to change application items regulated in this chapter shall apply for transaction in accordance with registration:

(1) Basic reaction theory changes in products;

(2) Cut-off or reference interval changes with new clinical diagnosis meaning;

(3) Other vital changes affecting product performance.

Article 60 As for documents of Change of Administrative Matters in accordance with requirements, the food and drug regulatory authority shall issue change registration document of medical device within 10 working days. For incomplete Change of Administrative Matters or the ones do not comply with formal reviewing requirements, the food and drug regulatory authority shall notify the full contents demanding to be supplemented once.

Article 61 As for Change of Approval Matters, the Technical Evaluation Institution shall evaluate it by focusing on the changing part and its effect on product performance and make evaluation on if the changed product safe and effective.

The food and drug regulatory authority accepting alteration in Change of Approval Matters, shall organize evaluation in the time limit regulated in h Chapter 6 of the Provisions.

Article 62 When change registration documents of medical device are applied with original registration certificate of medical device, the validity period is the same with this registration certificate. After getting change registration documents, the applicant shall revise technical requirement of product, instruction and label voluntarily in accordance with the alteration.

Article 63 Acceptance and approving procedure of Change of Approval Matters that are not regulated in this chapter are applicable to relevant provisions in Chapter 6 of the Provisions.

Chapter 8 Registration Extension

Article 64 When validity period of registration certificate of medical device is full and demands extension, the applicant shall apply for registration extension to the food and drug regulatory authority and submit application materials in accordance with relevant requirements six months before the validity period expiration of registration certificate of medical device.
Except for the situations regulated in Article 65 of the Provisions, the food and drug regulatory authority accepting application of registration extension shall make decision to approving extension before expiration of validity period. For the one does not make extension decision, it will be regarded as extension approval.

Article 65 The registration will not be extended if any one of the following situations exists:

(1) The applicant does not submit application of registration extension within the regulated time limit;

(2) Where the mandatory of IVD reagents have been revised or there is new national standard or reference and this IVD reagents cannot reach the new standard;

(3) As for IVD reagents that rare disease and treatment of emergency public sanitation events needing urgently, the registration approving department provides requests when it approves products launched onto market and the applicant does not accomplish statements of registration certificate of medical device within the appointed time limit.

Article 66 Acceptance and reviewing procedure of registration extension IVD reagents that are not regulated in this chapter are applicable to relevant regulations of Chapter 6 in the Provisions.

Chapter 9 Product Filing

Article 67 Product filing shall be transacted before manufacturing Class I IVD reagents.

Article 68 When manage filing of IVD, filing applicant shall submit filing materials in accordance with regulations in Article 9 of Regulations on Supervision and Administration of Medical Devices. 

As for filing materials qualified for requirements, the food and drug regulatory authority shall file on site; as for filing materials that is not intact or does not comply with regulation format, inform of the entire contents demanding supplement once and file after the filing applicant supplements them.

As for the filed IVD reagents, the food and drug regulatory authority shall compile filing certificate in accordance with relevant requirements and publish the information loaded in filing information list on its website.

Article 69 As for IVD reagents that have been filed, illustrations and relevant certificate documents on content changes in filing information list and the filed technical requirement of product shall be submitted by the filing applicant and the filing alteration information shall be submitted to the original filing department. As for filing materials qualified for format, the food and drug regulatory authority shall load the alteration in alteration information and file them.

Article 70 As for administration Class regulation of the filed IVD reagents, the filing applicant shall withdraw the original filing voluntarily from the food and drug regulatory authority; IVD reagents whose administration Class is regulated to Class II or Class III shall apply for registration in accordance with the Provisions.

Chapter 10 Supervision Administration

Article 71 CFDA is responsible for supervision administration of the national IVD reagents registration and filing and supervise and guide the IVD reagents registration and filing of local the food and drug regulatory authority

Article 72 The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government are responsible for supervising and administrating IVD reagents registration and filing in its administrative region, organizing and processing supervision and inspection and reporting relevant information to CFDA.

Article 73 The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government are responsible for implementing daily supervision administration for relevant work in imported IVD reagents agent registration and filing in accordance with territorial administration principle.

Article 74 The municipal food and drug regulatory authority where it is divided into districts shall inspect the filing regularly and report relevant information to the food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government.

Article 75 When the filed IVD reagents shall be deregistered regulated by lawsuit and regulations, or the validity period of registration certificate is not expire but the applicant submit deregistration voluntarily, the food and drug regulatory authority shall deregister in accordance with laws and publish it to the society.

Article 76 As for registered IVD reagents, its administration Class is regulated from the highest to the lowest and the registration certificate of medical device is still valid within validity period. If it needs extension, the applicant shall apply for registration extension or handle the filing formalities to the food and drug regulatory authority in accordance with the changed Class six months before the validity period expiration of registration certificate of medical device.

As for administration Class of IVD reagents regulated from the lowest to the highest, the applicant shall apply for registration to the food and drug regulatory authority basing on the changed Class in accordance with regulations in Chapter 6 of the Provisions. CFDA shall make provision on the time limit to finish regulation in regulation notice of administration Class.

Article 77 If The food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government violates the Provisions and implement IVD reagents registration, CFDA reserves the right to command it to correct; if the applicant does not correct after expiration, CFDA can announce to withdraw this registration certificate of medical device directly.

Article 78 The food and drug regulatory authority, relevant technical institution and its staffs are obligated for confidentiality of the test data and technical secrete submitted by the applicant or the filing applicant.

Chapter 11 Legal Responsibility

Article 79 Where the applicant obtains registration certificate of medical device by providing fake materials or adopting other deception methods, he will be punished in accordance with provisions in Clause 1 in Article 64 of Regulations on Supervision and Administration of Medical Devices.

Where the applicant submits fake materials in filing, he will be punished in accordance with provisions in Clause 2 in Article 65 of Regulations on Supervision and Administration of Medical Devices.

Article 80 Where the applicant forges, alters, transacts, rents or lends registration certificate of medical device, he will be punished in accordance with provisions in Clause 2 Article 64 of Regulations on Supervision and Administration of Medical Devices.

Article 81 Where the applicant violates the Provisions and does not manage alteration filing of Class I IVD reagents or registration item alteration of Class II and III IVD reagents, he will be punished in accordance with the relevant un-filing circumstance regulated in Regulations on Supervision and Administration of Medical Devices.

Article 82 Where the applicant violates regulations in the Provisions and does not manage alteration of registration license items of IVD reagents, he will be punished in accordance with relevant circumstance that does not obtain the registration certificate regulated in Regulations on Supervision and Administration of Medical Devices.

Article 83 Where the applicant does not process clinical test in accordance with Regulations on Supervision and Administration of Medical Devices and the Provisions, the food and drug regulatory authority above county level reserves the right to command it to correct and charge it with penalty under 30,000 yuan; as for the serious circumstance, the clinical test shall be terminated at once.

Chapter 12 Supplementary Provisions

Article 84 Registration or filing unit of IVD reagents registration shall be single reagents or single reagents kit, one registration or filing unit can include different package specifications.

Article 85 Format of registration certificate of medical device is compiled by CFDA uniformly.

Compiling of serial number of registration certificate is:

×1 Registration certificate of medical device ×2××××3×4××5××××6. Among it:

×1 is the shortened form of the place where the registration department locates:

Domestic Class III IVD reagents, imported Class II and III IVD reagents are “Guo”.

Domestic Class II IVD reagents are the shortened form of where the registration department at provincial, autonomous regional, municipal level locate;

×2 is the registration type:

“Zhun” is applicable to domestic IVD reagents;

“Jin” is applicable to imported IVD reagents;

“Xu” is applicable to IVD reagents in regions of Hong Kong, Macao and Taiwan;

××××3 is the first registration year;

×4 is administration Class of product;

××5 is code of product Class;

××××6 is the serial number of the first registration.

As for the registration extension, ××××3 and ××××6 do not change. As for the regulated administration Class of product, it shall be re-numbered.

Article 86 Compiling of serial numbers of Class I IVD reagents filing certificate is:

×1 Registration certificate of medical device No. ××××2××××3.

Among it:

×1 is the shortened form of the place where filing department locates:

Imported Class I IVD reagents are “Guo”;

Domestic Class I IVD reagents are shortened form of province, autonomous region and municipal level where the filing department locates plus the one of municipal administrative region where it is divided into districts (it is only the shortened form of province, autonomous region and municipal level if there is no municipal administrative region where it is divided into corresponding districts);

××××2 is filing year;

××××3 is serial number of filing.

Article 87 The emerged approval procedures for medical device and the special approval procedures for innovative medical devices shall be formulated by the CFDA separately.

Article 88 CFDA can consign the food and drug regulatory authority, technical institution, relevant social organization at province, autonomous region and municipal level to bear specific work of IVD reagents registration.

Article 89 Charging item and standard of IVD reagents registration shall be implemented in accordance with relevant regulations of financial and price authority department of State Council.

Article 90 The Provisions will come into force as of Oct. 1, 2014.