CFDA Order No. 5 2014
The newly revised Regulations for the Supervision and Administration of Medical
Devices was put into force on June 1, 2014. To support the implementation of the
Regulations, China Food and Drug Administration (CFDA) formulated and revised
Administrative Measures for Medical Device Registration, Administrative Measures
for the Registration of In Vitro Diagnostic Reagents, Administrative Rules for
the Instructions and Labels of Medical Devices, Administrative Measures for the
Supervision of Medical Device Manufacturing, and Administrative Measures for the
Supervision of distribution of Medical Devices. These five Administrative
Measures have been adopted at the executive meeting of CFDA on June 27, 2014,
and was promulgated on July 30, 2014 as CFDA Order No. 4, Order No.5, Order
No.6, Order No.7 and Order No. 8. These Administrative Measures will go into
effect as of October 1, 2014.
The Measures for the Administration of In-vitro Diagnosis Reagents is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, with a view to regulating the administration of in-vitro diagnosis reagents registration and filing, to guarantee the safety and effectiveness of in-vitro diagnosis reagents.
Apply for registration and filing for In-vitro Diagnosis Reagents which intend to be sold and use within the Chinese territory.
The in-vitro diagnosis reagents mentioned in these Measures refer to the in-vitro diagnosis reagents administered as medical devices, including the reagents, reagent cartridges, calibrators, quality controls, etc. for in-vitro inspection of human body specimen (various body fluids, cells, tissue specimen, etc.) in the course of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction, which can be used independently or in combination with instruments, devices, equipment or systems.
The in-vitro diagnosis reagents legitimately supervised as drug by the state for use in blood screening and radionuclide-labeled in-vitro diagnosis reagents do not belong to the administration scope of the Measures.
Registration of in-vitro diagnosis reagents refers to the approving process in which the authorities of food and drug supervision and administrations implement a systematic evaluation on the research conducted by the registration applicant as regards the safety, effectiveness and quality controllability of the products to be put on market and its results, and determine whether to approve such application, in accordance with legal procedures and the application of the registration applicant.
Filing for in-vitro diagnosis reagents refers to food and drug administration department check and file a record for filing materials submitted by proposer.
In-vitro diagnosis reagents registration and filing shall follow principles of fairness, justice and publicity.
Implement filing management for class I in-vitro diagnosis reagents, and registration management for class II, class III in-vitro diagnosis reagents.
Class I domestic in-vitro diagnosis reagents will be filed a record by food and drug administration departments at the level of the districted city.
Class II domestic in-vitro diagnosis reagents are subject to examination by the food and drug supervision and management departments of the local provinces, autonomous regions, municipalities directly under the central government, and medical device registration certificates will be issued after approval by such authorities.
Class III domestic in-vitro diagnosis reagents are subject to examination by the CFDA (China Food and drug administration department), and medical device registration certificates will be issued after approval by CFDA.
Class I imported in-vitro diagnosis reagents need to be filed a record in CFDA.
Class II, class III imported in-vitro diagnosis reagents are subject to examination by the CFDA, and medical device registration certificates will be issued after approval by CFDA.
In-vitro diagnosis reagents from Taiwan, Hong Kong and Macao shall be registered or filed a record by reference to the measures for the registration of import in-vitro diagnosis reagents.
The applicants for registration or filing a record for in-vitro diagnosis reagents shall sell the related products in the market by their own names and be liable for legal responsibilities.
Food and drug administration departments shall publish information related to in-vitro diagnosis reagents registration or filing in time legally. The applicant can inquire the approval rate of progress and results, the public can inquire approval results.
The state encourages medical devices research and innovation and implements special approval procedure for innovative medical device, promotes the application of medical devices new technology and medical devices industry development.
The applicants for registration or filing a record shall establish quality management system related to product research and manufacture, maintain it work effectively at the mean time.
If entrust other manufacturers to manufacture samples for domestic in-vitro diagnosis reagents which can be approved through special approval procedure, the entrusted manufacturer’s qualification should cover related scope; Samples which cannot be approved through special approval procedure should not be entrusted to manufacture.
The person handling the matters related to application for in-vitro diagnosis reagents registration (filing) shall have the corresponding professional knowledge and be familiar with the laws, rules, regulations and technical requirements on the administration of medical device registration (filing).
In-vitro diagnosis reagents research and development include: selection and preparation of main raw materials, manufacturing technique confirmation, draft of product technical requirements, stability study, positive judgment value and reference interval confirmation, product analysis performance assessment, clinical evaluation, etc.
Applicant can research and develop products referring to related technical guidance principles or via various test method, technical means and provide instructions of rationality.
The applicant for registration or filing shall follow essential requirements of safety and effectiveness of in-vitro diagnosis reagents, guarantee normalization in the development process and all the data should be authentic, intact and traceable.
The submitted materials for registration or fling should be in Chinese. Provide original text if the submitted materials are translation version according to foreign language. Approval certificate issued by the data owner shall be provided when the quoted document has not been published.
Applicants should take full responsibility for the authenticity of the submitted materials.
When apply for the registration (filing) of a foreign in-vitro diagnosis reagents in China, the foreign sales license for in-vitro diagnosis reagents in original state or region is needed.
If the foreign product is not supervised as a medical device in original state or region, the applicant shall provide related certificate documents, including the foreign sales license in original state or region.
Regarding application for the registration (filing) of foreign medical devices, the foreign manufacturer via its representative office in China or a designated organization located within the territory of China to act as the foreign manufacturer’s agent to apply for the registration (filing).
Agent within the territory of China for the foreign applicant shall bear the following responsibility:
Other responsibility related to product quality and after-sale service.
In-vitro diagnosis reagents are successively classified into Class I, Class II and Class III products from lower to higher risk degree.
Class I products:
Class II products: products not clearly defined as Class III and Class I products are Class II products, mainly including:
Class III products:
If the inspection of some Class II products are used for the monitoring of tumor diagnosis, auxiliary diagnosis and treatment process, or used for diagnosis and auxiliary diagnosis, etc. of inherited diseases, these products are registered and administered as Class III products. Among the reagents for inspection drugs and drug metabolites, if the drugs belong to the scope of narcotic drugs, psychotropic drugs and toxic drugs for medical use, they are registered and administered as Class III products.
For in-vitro diagnosis reagents such as calibrators and quality controls, they can be applied for registration independently or together with matched in-vitro diagnosis reagents. If the classification of matched in-vitro diagnosis reagents are class I, calibrators and quality controls shall be registered as class Ⅱ; if the classification of matched in-vitro diagnosis reagents are class Ⅱ, class Ⅲ, the classification of calibrators and quality controls shall be the same as that of matched in-vitro diagnosis reagents. The classification of multiple calibrators and quality controls shall be the same as that of the highest class.
CFDA will be responsible for making and adjusting the catalogue of in-vitro diagnosis reagents classification.
The applicant can register the in-vitro diagnosis reagents which are new and have not listed in the catalogue according to the class III registration regulation, and can also determine product categories in accordance with classification principles and apply to CFDA for category identification, and then do the registration or record procedures based on this regulation.
CFDA should identify the category of in-vitro diagnosis reagents which are directly registered as class III products according to the degree of risk. If censored and registered as class II domestic medical devices, CFDA will transfer the submitted materials to food and drug administration department of provinces, autonomous regions and municipalities in locus of the applicants to determine whether approve and issue the registration certificate or not. If censored and registered as class I domestic medical devices, CFDA will transfer the submitted materials to food and drug administration department of cities with districts in locus of the applicants to file a record.
Product names of in-vitro diagnosis reagents are generally composed of three parts:
First part: name of the substance tested.
Second part: usage, e.g. diagnosis serum, diagnostic reagent cartridge, quality control, etc.
Third part: method or principle, e.g. enzyme linked immunity method, colloidal gold method, etc., this part shall be listed in parentheses.
If the substance for inspection have too many components or under special circumstances, the substance can adopt the indication name related to the product or other substitute names.
Applicants shall draft product technical requirements according to results of product research, clinical trials, etc. and national standard, industrial standard, related document literature under the conditions that raw material quality and manufacturing technique is stable.
Product technical requirements mainly contain performance indexes and test methods for finished products. The performance indexes refer to indexes which can give objective assessment of the functionality, security and quality control.
Product technical requirements for class Ⅲ in-vitro diagnosis reagents shall make clear of main raw material, manufacturing technique and semi-finished product requirements in the form of appendix.
Product technical requirements for class I in-vitro diagnosis reagents shall be submitted to related food and drug administration department. Product technical requirements for class II, class III in-vitro diagnosis reagents will be checked and approved by food and drug administration department during the registration.
In-vitro diagnosis reagents applied for sales in Chinese market should conform to the approved product technical requirements.
Implement registration test when register class II, class III in-vitro diagnosis reagents. Registration test with specimens of 3 consecutive production batches shall be carried out for Class III products. Medical device test organizations shall test the samples according to product technical requirements.
Samples for registration test should be manufactured according to related requirement of medical device quality management system. Only those with a qualified registration test can carry out clinical trials or apply for registration.
For filing class Ⅰ products, the applicant can submit product self-report.
When applying for registration test, the applicant shall submit technical materials, samples for inspection and product technical requirements and standards or references to medical device test organizations.
Domestic test samples will be random samples selective by food and drug administration department.
National standards and references products shall be used in registration test if they have existed, otherwise, the national institutes for food and drug control will undertake preparation and standardization for national standards and references products.
Medical device test organizations should have medical device inspection qualification within the test range, and pre-assess product technical requirements, the pre-assessment opinion will be issued along with registration test report to the applicant.
Medical devices have been beyond the test range of the test organizations, the related registration examination and approval department will designate a qualified test organization to test the medical devices.
Only one packaging specification is needed to be inspected for a registration application with various packaging specifications.
Clinical trials evaluation is a process to assure the products can meet the use requirements or application scope via clinical document literature, clinical empirical data, clinical trials, etc.
Clinical trials materials refer to documents formed during clinical trials evaluation by applicant.
The clinical trials of in-vitro diagnosis reagents (clinical validation including comparative research with the products already put on the market) refers to the systematic research on the clinical performance of in-vitro diagnosis reagents in corresponding clinical environment.
If clinical trials of in-vitro diagnosis reagents can be exempted, the applicants shall evaluate clinical performance via non-clinical trial means, e.g. intended use, clinical sample evaluation of interference factor, comprehensive document literature, etc. Furthermore, applicant shall guarantee traceability of clinical samples used in evaluation.
Clinical trials are needed to be carried out when registering class II, class III medical devices but not when filing a record for class I medical devices. Clinical trials can be exempted when conform to one of the following circumstances.
Only one packaging specification is needed to be carried out clinical evaluation for a registration application with various packaging specifications.
The applicants for Class III products shall choose no less than 3 (including 3) provincial-level health & medical institutions, and the applicants for Class II products shall choose no less than 2 (including 2) qualified clinical trials institutions to carry out the clinical trials according to related regulations. Samples for clinical trials shall be manufactured according to related requirement of quality management system.
The applicant shall sign a clinical trials contract with the clinical trials organization, formulate and perfect the clinical trials scheme by referring to relevant technical guidance principles, provide specimens for clinical trials free of charge, and pay the expenses for clinical trials.
The number of cases for clinical trials shall be determined according to the purpose of clinical trials, statistical requirements, and by referring to relevant technical guidance principles. Technical guidance principles for clinical trials are issued separately.
For in-vitro diagnosis reagents in urgent need of rare disease treatment and dealing with public health emergencies, if the applicant requests to decrease the number of cases for clinical trials or not to perform clinical trials, the applicant shall submit the materials for registration application together with the application for decreasing the number of cases for clinical trials or exempting the clinical trials, and explain the reasons in a detailed way. The technical review organization of authorities of food and drug administration department shall make the decision after all-round technical review of the materials for registration application, and if clinical trials need to be supplemented, shall inform the applicant in the form of supplementary materials.
When applying for foreign product registration, foreign clinical experiment materials are required. The applicant shall consider at the same time many factors such as the epidemiological background, characteristics of various diseases, normal reference values (or reference scope) applicable to crowds of different species, and carry out corresponding clinical experiments within Chinese territory in accordance with the requirements of clinical experiment.
After accomplishing the clinical experiment, the organizations of clinical experiment shall respectively issue the reports of clinical experiment. The applicant or the unit leading the clinical experiment shall summarize the results of clinical experiment and complete the summary report of clinical experiment in accordance with relevant technical guidance principles.
In-vitro diagnosis reagents used by consumers themselves, cognitive competence evaluation of consumers without medical science background for product manuals shall be included.
If the organization of clinical experiment is found to have breached relevant provisions or fail to execute the scheme of clinical experiment, the applicant shall urge the organization to correct; if the circumstances are serious, the applicant can require the organization to suspend or terminate the clinical experiment, and report to the provincial-level authorities of food and drug administration department in the locality and CFDA.
If the applicant breaches relevant provisions or requests to change the data, conclusions of the experiment, the organizations and personnel participating in the clinical experiment shall report to the provincial-level authorities of food and drug administration department in the locality and CFDA.
Clinical trials should be filed a record in the food and drug administration department of local provinces, autonomous regions or municipalities directly under the central government. The food and drug administration department which accept the record should announce it to the food and drug administration department at the same level and the health and family planning commission department where the clinical test units are located.
CFDA and authorities of food and drug administration department in provinces, autonomous regions and municipalities directly under the central government need to carry out supervision and inspection on the implementation status of the clinical experiment.
Applicant shall submit application materials to related food and drug administration department when applying for medical device registration.
After a food and drug administration department authority receives an application, this authority shall do formal examination after receiving the application, and dispose of the application respectively according to the following circumstances:
After accepting or rejecting an application for in-vitro diagnosis reagents registration, the food and drug administration department authority shall issue a notice of acceptance or a notice of rejection that is stamped with special seal of the food and drug administration department authority and dated.
The food and drug administration department authority which accept the registration application shall transfer the application documents to the technical assessment institute within 3 working days.
Technical assessment institute shall finish technical assessment for class II in-vitro diagnosis reagents within 60 working days, and that for class III in-vitro diagnosis reagents within 90 working days.
Time required in inviting external experts will not be calculated in the technical assessment period, technical assessment agency shall inform the needed time to the applicant.
Technical assessment institute of the food and drug administration department authority can check and read related original document if necessary during technical assessment and can also organize examination the quality management system related to product research and manufacture.
Examination of quality management system for domestic class Ⅱ, class Ⅲ in-vitro diagnosis reagents will be implemented by food and drug departments of the local provinces, autonomous regions, municipalities directly. CFDA will inform the local provinces, autonomous regions, municipalities directly food and drug departments to check the quality management system and participate in the check if necessary. The local provinces, autonomous regions, municipalities directly food and drug departments shall finish quality management system examination within 30 working days according to related requirements.
If CFDA feels the need to check the quality management system when launch the technical evaluation for imported class Ⅱ, class Ⅲ in-vitro diagnosis reagents, it should organize the technical institutions for inspecting the quality management system to check the quality management system.
Time required in checking the quality management system will not be calculated in technical evaluation period.
During the technical examination of application documents for medical device registration, the food and drug administration department authority shall issue the applicant a notice for the supplementation of documents once and for all. The applicant shall fully supplement the necessary documents once and for all within a year in accordance with the requirements of the notice. The technical examination institute shall finish the technical examination within 60 working days after receiving the supplement documents. Time of documents supplement shall not be calculated in technical examination period.
The applicant can give a written opinion and supporting materials to the corresponding technical assessment agency if dissent with supplementation materials.
If applicants do not submit supplementation materials within the given period, technical assessment agency will terminate technical assessment and propose suggestion of refusing registration, and food and drug administration department will give the refused determination after checking.
The food and drug administration department which accept the application should make the decision within 20 working days after finishing the technical evaluation. Permit the applicant to register if the product meets the requirements of the safety and effectiveness, and issue the registration certificate of medical devices within 10 working days; For those do not comply with the requirements, reject the registration and give a written explanation and inform the applicant of the right to reexamine or apply for administrative reconsideration or propose administrative litigation.
The valid period of each medical device registration certificate shall be five years.
In-vitro diagnosis reagents registration items include approval items and recording items. Approval items include product name, package specification, main ingredient, intended use, technical requirements, product manual, expiration date, manufacture address of imported in-vitro diagnosis reagents, etc.; Recording items include name and address of the applicant, name and address of the agent, manufacture address of domestic in-vitro diagnosis reagents, etc..
For in-vitro diagnosis reagents in urgent need of rare disease treatment and dealing with public health emergencies, food and drug administration department can request the applicant to finish related task after post-marketing, furthermore, state the requirement on the medical device registration certificate.
The food and drug administration department shall reject the registration and give an explanation to the applicant if the received application conforms to the following circumstances:
If the application has been accepted, the applicant shall give an explanation to the food and drug administration department which accept the application before administrative approval and withdraw the registration application.
If there are proofs to certify that the application materials of the received registration application are mendacious, food and drug administration department shall terminate examination. Continue to examine or decide not to register based on the result of the check.
The applicant can propose the food and drug administration department to reexamine within 20 working days from receiving the refusing registration decision if dissent with the it. The reexamination content is limited to the original items and application materials.
Food and drug administration department shall decide whether to do the reexamination within 30 working days dating from receiving the reexamination application and give a written notice to the applicant. Food and drug administration department will not accept the reexamination application proposed by the applicant again if maintains the original decision.
Food and drug administration department will refuse reexamination application if the applicant was dissent with the decision and has applied for administrative reconsideration or administrative litigation.
Where a Medical Device Registration Certificate is lost, the in-vitro diagnosis reagents applicant shall make a public announcement about the loss on the media designated by the original license-issuing authority immediately and apply to the original license-issuing authority for a reissue after one month of the public announcement, the original license-issuing authority shall issue a new Medical Device Registration Certificate within 20 working days.
The product technical requirements and product manual shall be accordance with the content of that which has been approved by related food and drug administration department when the in-vitro diagnosis reagents appears on the market. Applicants shall track the safety and effectiveness of the products after sale and apply for product technical requirements and product manual alteration if necessary.
The food and drug administration department shall inform the applicant and interested party the right of hearing application according to laws, regulations and other regulations made by CFDA as the registration application is directly related to major interest relationship between the applicant and others. The food and drug administration department shall publicize to the society and hold a hearing if the in-vitro diagnosis reagents registration application is thought to be involved in major approval items of public interest.
Patent disputes occurred in the examination process or after approval shall be handled according to related laws and regulations.
If the content on the registration certificate and its attachment of the registered class II, class III in-vitro diagnosis reagents have been changed, the applicant shall apply to the original license-issuing authority for registration change and submit application materials according to related requirement.
If the changed items are name and address of the applicant, name and address of the agent, applicant shall apply for recording items alteration to related food and drug administration department; If manufacture address for domestic in-vitro diagnosis reagents has been changed, applicant shall apply for manufacture approve alteration prior to recording approval alteration.
If the content and its attachment of the registration certificate have been changed, the applicant shall apply to the original license-issuing authority for registration alteration:
The following circumstances do not belong to the issues of change application as stipulated in this chapter, and shall be handled as registration application:
The food and drug administration department shall approve the alteration within 10 working days if the materials for registration alteration for recording items conform to requirements and issue medical device registration alteration documents. If the materials for recording items alteration are incomplete or do not conform to the regulation of formal examination, the food and drug administration department shall issue the applicant a notice for the supplementation of documents once and for all.
Technical examination institute shall focus on the changed part for assessment towards approval items change, and evaluate whether the changed products are safe or effective.
Food and drug administration department shall organize technical assessment within the limited period according to regulations on chapter 6 after accepting the approval items alteration application.
The registration alteration approval and the original medical device registration certificate are united to be used and the valid period is in accordance with that of the original registration certificate. The applicant shall amend technical requirement, instruction manuals, labels based on the changed items in the approval voluntarily.
If the procedure for examination and approval of application for registered items change is not included in this article, it applies to related regulations in chapter 6.
The holder of the certificate shall apply for extending the validity term of registration 6 months before the certificate expires if the certificate expires come near. Apply to the related food and drug administration department for extending registration and submit application materials according to the corresponding requirements.
Food and drug administration department shall make decision of extending approval before the certificate expires if do not has the circumstances in article 65 in this provision. If the determination is not made beyond the certificate expires, the certificate is deemed to be approved extending.
Refuse extending registration if conform to the following circumstances:
The procedure for examination and approval of application for extending registration is not included in this article, it applies to related regulations in chapter VI.
File a record for classⅠ products prior to products manufacture.
The applicant shall submit the materials for filing a record according to the corresponding requirements in article 9 of Regulations for the Supervision and Administration of Medical Devices.
Food and drug administration department will file a record on the spot if the materials conform to requirements or make a notice for the supplementation or correction of documents to the applicant to inform the applicant of all the contents that need to be supplemented or corrected once and for all if the application documents are incomplete or do not meet the regulated formal; applicant can file a record after the supplement.
Food and drug administration department shall make filing certificate according to related requirement for classⅠ products, furthermore, information stated on the filing information sheet will be published on its website.
If the content in the filing information sheet or product technical requirements have been changed, the record proposer shall submit the illustration of the changed contents and related certificate documents to apply to original issuing authority for information alteration application. The food and drug administration department will file a record for those whose record materials conform to the formal requirement and the related information will be updated on the website.
If in-vitro diagnosis reagents classification was adjusted, the record proposer shall apply to the food and drug administration department for canceling the filing proactively; if in-vitro diagnosis reagents classification was adjusted to class II or class III in-vitro diagnosis reagents, apply for registration according to regulations in this provision.
CFDA is responsible for supervision and administration of in-vitro diagnosis reagents nationwide, supervise and guide registration and filing task in local food and drug administration department.
Food and drug administration departments of the local provinces, autonomous regions, municipalities directly under the central government is responsible for supervision and administration of in-vitro diagnosis reagents registration and filing within its own area, organize supervision and examination, furthermore, report related information to CFDA in time.
Food and drug administration departments of the local provinces, autonomous regions, municipalities directly under the central government will implement daily supervision and administration for registration and filing task of imported in-vitro diagnosis reagents by agents according to its local regulations.
Food and drug administration department of the municipalities consisting of districts shall carry out examination of filing task regularly and report related information to food and drug administration department of the local provinces, autonomous regions, municipalities directly under the central government.
Food and drug administration department can repeal the registration certificate and publish to the public when the registered in-vitro diagnosis reagents conform to circumstances of repealing according to laws or regulations or the applicant apply for repealing within the valid period of registration certificate.
Medical device registration certificate will be effective if its classification was adjusted from high classification to low classification within its valid period. The applicant shall apply for extending registration or filing a record 6 months before the certificate expires on the basis of new classification if necessary.
Applicant shall refer to regulations in chapter 6 to apply for registration based on new classification if the classification was adjusted from low classification to high classification. CFDA shall make rules for in-vitro diagnosis reagents adjustment period in the notice of classification adjustment.
Food and drug administration department of provinces level who break the rule during the registration approval will be ordered to make corrections within a time limit by CFDA. CFDA will directly announce to repeal registration certificate if it fails to make corrections.
Food and drug administration department, the related technical institute and its staff shall keep secret of the submitted test data and technology.
Achieve Medical device Registration Certificate via false materials or other deception means, penalize the related party according to article 64 in Regulations for the Supervision and Administration of Medical Devices.
Provide fake materials for filing, penalize the related party according to article 65 in Regulations for the Supervision and Administration of Medical Devices.
If Medical device Registration Certificate is forged, changed, bought and sold, rented, lent, penalize the related party according to article 64 in Regulations for the Supervision and Administration of Medical Devices.
Violate regulations in this provision by failing to apply for filing alteration for classⅠproducts or recording items registration alteration for class Ⅱ, class Ⅲ products, penalize the related party according circumstances of failing to file a record in Regulations for the Supervision and Administration of Medical Devices.
Violate regulations in this provision by failing to apply for approval items alteration registration, penalize the related party according circumstances of failing to achieve a Medical device Registration Certificate in Regulations for the Supervision and Administration of Medical Devices.
Food and drug administration departments at county level and above shall order applicants who fail to carry out clinical trials according to Regulations for the Supervision and Administration of Medical Devices and this provision to make corrections and can fine less than 30000 yuan; Clinical trials will be terminated immediately if the circumstance is serious.
The unit of in-vitro diagnosis reagents registration or filing shall be single reagent or single kit, and a registration or filing unit can include different packing specification.
Medical device registration certificate format shall be made by CFDA uniformly.
×1 shall mean the abbreviation of the place where the registration examination and approval authority is located:
The letter “国” shall be adopted for Category III domestic in-vitro diagnosis reagents, Category II, III foreign in-vitro diagnosis reagents;
The abbreviation of the province, autonomous region or municipality where the registration examination and approval authority is located shall be adopted for Category II in-vitro diagnosis reagents;
×2 shall indicate registration form;
“准” is applicable to domestic in-vitro diagnosis reagents;
“进” is applicable to foreign in-vitro diagnosis reagents;
“许” is applicable to in-vitro diagnosis reagents from Taiwan, Hong Kong and Macao;
××××3 shall indicate the year of approval for the original registration;
×4 shall indicate the category of product administration;
××5 shall indicate the type code of product;
××××6 shall indicate serial number of the original registration.
For the extending registration, the numbers of ××××3 and ××××6 will remain unchanged. New registration numbers will be issued if the category of product administration has been changed.
The filing certificate numbers for class Ⅰ products shall be arranged in the following form:
×1械备××××2××××3号. Where:
×1 shall mean the abbreviation of the place where authority which files a record for class Ⅰ products is located:
The letter “国” shall be adopted for class Ⅰ foreign in-vitro diagnosis reagents;
The abbreviation of the province, autonomous region or municipality where authority which files a record is located plus the abbreviation of the local municipal level administrative area with districts shall be adopted for class I domestic in-vitro diagnosis reagents (only the abbreviations of the local province, autonomous region or municipality shall be adopted if there is no corresponding municipal level administrative area with districts);
××××2 shall indicate the year when filing a record;
××××3 shall indicate serial number for filing a record.
Procedure for emergency approval and special approval will be made by CFDA separately.
CFDA can entrust food and drug administration departments of the local provinces, autonomous regions, municipalities directly under the central government or technical organizations, related social organization to undertake related task for medical device registration.
Charging items and charging standards for medical device registration can be implemented based on related regulations of financial departments and price competent departments in State Council.
This provision will come into force from 1st October 2014, Measures for the Administration of In-vitro Diagnosis Reagents (interim) issued on 19th April 2007 will be abolished meanwhile.
