Administrative measures for the registration of in vitro diagnostic reagents
(July 30, 2014, the State food and drug administration released 5th come into force October 1, 2014) Chapter I General provisions
First to standardize the registration and record management of in vitro diagnostic reagents, ensuring safe, effective in vitro diagnostic reagents, under the supervision and administration of medical devices Ordinance, these measures are formulated.
Article in the People's Republic of China territory, the use of an in vitro diagnostic reagent shall be in accordance with these regulations for registration or filing. Article the term chengti vitro diagnostic reagents, are defined as reagents for in vitro diagnostic medical device management, including disease prediction, prevention, diagnosis, treatment, monitoring, prognosis and health status evaluation process, used for testing human samples in vitro reagents, kits, calibration, quality control products and other products.
Can be used alone, can also be used in combination with instruments, apparatus, equipment or systems.
In accordance with the management of drugs used for blood screening of in vitro diagnostic reagents and radionuclides marked in vitro diagnostic reagents, these procedures do not belong to the scope of management.
Fourth registration of in vitro diagnostic reagents are food and drug supervision and management departments according to the applicant's request, in accordance with legal procedures, on its planned in vitro diagnostic reagents for safety and effectiveness research and systematic evaluation of the results, to decide whether to agree to the application process.
In vitro diagnostic reagents for the record is the record man filings submitted to the food and drug administration, food and drug supervision and management departments to submit filings archive for future reference.
Fifth in vitro diagnostic reagents for registering and filing shall follow the principle of openness, fairness and impartiality.
Sixth article types of in vitro diagnostic reagents to implement records management, class II and class III in vitro diagnostic reagents the registration management.
Domestic first class record of in vitro diagnostic reagents, the filing to the district, the municipal food and drug supervision and management departments to submit filings.
Second types of in vitro diagnostic reagents in the provinces, autonomous regions and municipalities directly under the food and Drug Administration reviewed, approved and issued registration certificate of medical devices.
Class III in vitro diagnostic reagents in the territory by the State food and Drug Administration reviewed, approved and issued registration certificate of medical devices.
Imported the first types of in vitro diagnostic reagents for the record, the record people submitted filings to the State food and drug administration.
Import category II and class III in vitro diagnostic reagents for review by the State food and drug administration, approved and issued registration certificate of medical devices.
Hong Kong, Macao, Taiwan area registration of in vitro diagnostic reagents, for the record, refer to imports of in vitro diagnostic reagents for processing.
Seventh in vitro diagnostic reagents registered products onto the market, putting in its own name on product liability. Eighth section food and drug supervision and Administration Department shall timely publication of in vitro diagnostic reagents registration, record information.
Applicants can check the approval progress and results, available to the general public of the outcome.
Nineth State encourages in-vitro diagnostic reagents for research and innovation, and innovation in vitro diagnostic reagents for special approval, promotion of in vitro diagnostic reagents the popularization and application of new technologies, promote the development of medical device industry.
Chapter II basic requirements
Application for registration article tenth in vitro diagnostic reagents and the record shall be established relating to product development, production and quality management system, and maintain effective operation.
In accordance with the special procedure-approval within of innovative medical devices registered in vitro diagnostic reagents, commissioned production of the samples, shall be entrusted with corresponding production range of medical device manufacturers; not in accordance with the special procedure-approval within of innovative medical devices registered in vitro diagnostic reagents, samples shall not be entrusted to another production.
Article 11th in vitro diagnostic reagents for registration or filing service personnel should have appropriate expertise, familiar with the management of medical device registration or filing laws, rules and regulations and the technical requirements.
12th reagents for in vitro diagnostic product development including: mainly the selection of raw materials, preparation, determination of the production process, the elaboration of technical requirements for products, product stability, positive values, or reference interval determined, product analysis performance evaluations, clinical evaluation and other related work.
Applicant or filing can refer to technical guidelines related to product research, may also use a different method or technique, but should indicate that it makes sense.
13th or filing applications for registration or filing of the applicant shall follow the requirements for safe and effective in vitro diagnostic reagents to ensure development process specifications, all data authenticity, integrity and traceability. 14th applied for registration or filing of information shall be in Chinese. Based on the translation of foreign language materials, should also provide the original text.
Reference document that is not published, shall provide proof of information used by the permission of the owner.
Record is responsible for the authenticity of the data of the applicant.
15th application for registration or for the record imports of in vitro diagnostic reagents, or filing registration or address of the applicant countries (regions) has been allowed to go on sale.
Or filing registration or address of the applicant countries (regions) the products as medical devices are not managed, or filing required of the applicant to provide the relevant documents including registration or address the host country (region) to allow sales documents for the products listed.
16th overseas applicant or record shall, through its set up in China's representative office or designated enterprise in China as agents, tie or filing relevant work of the applicant.
Apart from handling agent in vitro diagnostic reagents outside registration or filing, shall assume the following responsibilities:
(A) with appropriate food and drug regulatory agency, offshore or filing of the applicant's contact;
(Ii) to the applicant or for the record people truthfully and accurately communicate relevant regulations and technical requirements;
(C) collection of postmarketing adverse event information and feedback outside of in vitro diagnostic reagents registered persons or for the record people, and to the corresponding report of the food and drug administration;
(D) coordination of in vitro diagnostic reagents after the listing of the product recall and the corresponding report of the food and drug administration;
(E) other related to product quality and after-sales service of joint and several liability.
Chapter III product classification and nomenclature
17th according to the degree of risk from low to high, in vitro diagnostic reagents classified into category I, category II and category III products.
(A) first class products
1. microbiological medium (not used for microbial identification and susceptibility testing);
2. sample processing products, such as hemolysis, diluent, staining, etc.
(B) category II products
In addition to has made it clear for the first class and third class product, the other for category II products, mainly including:
1. for detection of protein reagents;
2. reagents for detection of sugars;
3. reagents for detection of hormones;
4. reagents for detection of enzymes;
5. reagents for detection of esters;
6. reagents for detection of vitamins;
7. reagents for detection of inorganic ions;
8. reagents for detection of drugs and drug metabolites;
9. the reagents for detection of auto-antibodies;
10. for microbial identification and susceptibility testing reagents;
11. for other physiological, biochemical or immune function detection reagents.
(C) the third category of products
1. pathogenic antigens, antibodies and nucleic acid detection reagent
2. associated with blood type, tissue typing reagents;
3. associated with the human gene testing reagent
4. reagents associated with hereditary diseases;
5. narcotic drugs, psychotropic substances, toxic drugs for medical testing reagents;
6. associated with a therapeutic drug target detection reagents
7. associated with tumor markers detection reagents
8. allergic reactions (allergens) associated reagents. 17th 18th article of class II products listed in section as used in tumor diagnosis and monitoring the process of diagnosis, treatment, or for diagnosis, diagnosis of hereditary diseases, according to category III product registration management.
Reagents for detection of drugs and drug metabolites, if the drug is narcotic drugs, psychotropic substances or toxic drugs for medical use range, according to category III product registration management.
19th calibration and quality control products can be used in conjunction with the registration of application for consolidation of in vitro diagnostic reagents, can also be applied for registration.
Used in conjunction with the first types of in vitro diagnostic reagents calibrators, quality control, by class II products to register with class II and class III in vitro diagnostic reagents for use with calibration and quality control material apply separately for registration, registered under the category with the same reagent; number of calibrators, quality product, according to one of the higher class to register.
20th the State food and Drug Administration is responsible for product categories of in vitro diagnostic reagents development and adjustment.
New development has not been included in the catalogue of the in vitro diagnostic reagents of in vitro diagnostic reagents, applicants can register directly with applications for class III in vitro diagnostic reagents products, classification rules can be based on product category apply to the State food and Drug Administration category is confirmed, to apply for registration or handling the products record. Direct registration of applications for class III in vitro diagnostic reagents, the State food and Drug Administration determined according to the degree of risk categories.
In vitro diagnostic reagents in the territory identified as second class, the State food and Drug Administration to transfer the information to the applicant where provinces, autonomous regions and municipalities directly under the food and drug administration review and approval territory determined in vitro diagnostic reagents for the first class, the State food and Drug Administration declared data transfer where the applicant is located the municipal food and drug supervision and Administration Department for the record.
21st the naming of in vitro diagnostic reagents should be guided by the following principles: Reagents for in vitro diagnostic product name usually consists of three parts.
First part: the name of the substance being tested; part II: uses, such as diagnostic serum and assay Kit, quality product; part III: method or principle, such as enzyme-linked immunosorbent assay, immunogold method, this part should be listed in parentheses.
If the analyte components more or have other special circumstances, you can use indications associated with the product name or alternative name.
First class products and calibration, quality product, named according to its intended use.
The fourth chapter product technical requirements and registration, inspection
22nd applicant or record shall, quality of raw materials and production stability under the premise, according to product development, clinical evaluation of results, based on national standards, industry standards, and related documents, development of technology products.
Product specification includes in vitro diagnostic reagents products performance and test methods, performance refers to the functions that can be objectively determined product, safety indicators, as well as other indicators related to quality control.
Class III in vitro diagnostic reagents products technical requirements in Appendix form should be made clear in the main raw materials, production process and semi-finished product requirements. First class product technical requirements for in vitro diagnostic reagents for the record people filing submitted to the food and drug administration.
The second category, technical requirements for class III in vitro diagnostic reagents products approved by the food and Drug Administration approved registration.
In China of in vitro diagnostic reagents shall conform to register approval or for the record of technology products. 23rd application for class II and class III in vitro diagnostic reagents registered shall be registered; III class 3 successive production batches of the products should be registered.
Medical device inspection institutions related products should be based on technical requirements for products to be tested.
Registration test samples of production shall conform to related requirements for medical device quality management system, registration qualified to be tested in clinical trials or applied for registration.
Go through first class record of in vitro diagnostic reagents, record people can submit a self test report.
24th inspection of application for registration, the applicant shall provide the inspection bodies with registration and inspection and the need for technical information, registered samples for inspection, product technical requirements and standards or reference materials.
Applicant's registration in the territory pulled samples for inspection by the food and drug administration. 25th national standard, reference product should use standard, register reference for testing.
China's food and drug inspection Institute was responsible for organizing the national standards, preparation and calibration of reference work. 26th medical device inspection bodies shall have test qualification, testing in the context of the tester and pre-evaluation of technical requirements for the product submitted by the applicant.
Pre assessment issued along with the registration test report to the applicant.
Have not been included in the medical device inspection inspection of products registered by the appropriate approval authority specifies the competent inspection bodies for examination.
27th same registration application includes different packaging specifications, a packaging specification can only test for product register.
Clinical evaluation of the fifth chapter
28th clinical evaluation of in vitro diagnostic reagents refers applicants or filing through the clinical literature data, clinical trials, clinical experience, and other information on whether products meet the requirements of or intended use for a confirmation process.
29th clinical evaluation refers to the applicant or filing for clinical evaluation form file.
In vitro diagnostic reagents for clinical trials (including comparison tests with the products already on the market) is in the appropriate clinical setting, the clinical performance of in vitro diagnostic reagents for systematic study. Without clinical testing of in vitro diagnostic reagents, or record should be based on the cover of the applicant intended use clinical samples and interference factors of assessment, comprehensive documentation and other non-clinical trial to evaluate the clinical performance of in vitro diagnostic reagents.
Applicant or record shall ensure that an evaluation of the clinical sample traceability. Article 30th first class record of in vitro diagnostic reagents, clinical trials are not required.
Application registration of class II and class III in vitro diagnostic reagents, clinical trials shall be conducted.
Any of the following circumstances, clinical trials can avoid:
(A) the definite reaction principle, design, sophisticated production technology, already on the market with in vitro diagnostic reagents in clinical application for many years and no serious adverse events recorded, does not change the General purpose, applicants will be able to provide equivalent to products already on the market evaluation of data;
(Ii) to cover the expected use and interfering factors of evaluation of clinical samples can demonstrate the in vitro diagnostic reagents is safe and effective.
From the list of in vitro diagnostic reagents for clinical trials by the State food and Drug Administration be formulated, adjusted and published.
31st the same application for registration when including different packaging sizes, can only one package of samples for clinical evaluation. Article 32nd products the applicant shall select not less than 3 (3), a second class product applicant shall select not less than 2 (2) qualification of the clinical trial, clinical trials carried out in accordance with the relevant provisions.
Clinical trial of production shall conform to medical devices quality management system requirements.
33rd applicants should be entered into clinical trials and clinical trial contracts, refer to the relevant technical guidelines to develop and improve clinical trial protocols, provide free samples for clinical testing, and bear the costs of clinical trials. 34th clinical trials number of cases should be under clinical purposes, statistical requirements and the relevant technical guidelines to determine.
Technical guidelines for clinical trials published separately. For the rare disease and response to emergent public health events in urgent need of in vitro diagnostic reagents, asked to reduce the number of cases of clinical trials or clinical trials, the applicant shall submit registration documents at the same time, proposes to waive the application for clinical trials, and detailed explanations.
Technical review of the food and drug administration bodies following a technical review of registration documents to be determined, needed additional clinical trials, inform the applicant to supplement information. 35th for import registration of in vitro diagnostic reagents, clinical evaluation of the need to provide the information.
Clinical assessment shall be in accordance with the requirements of the applicant, taking into account different national or regional epidemiological background and different disease characteristics, different species groups for positive values, or reference interval and other factors, targeted clinical evaluation in China. Article 36th clinical trial agency upon completion of the clinical trial, each Party shall provide the clinical trial report.
Applicant or focal point according to the relevant technical guidelines in clinical trials, the clinical trial results were summarized, and completed clinical trials summary report.
37th from consumer use of in vitro diagnostic reagents, clinical trials should include consumer product specifications with no medical background evaluation of cognitive ability.
38th applicant find clinical trials for breaches of the relevant provisions or does not perform a clinical trial protocol, should urge their correction in serious cases, suspended or terminated clinical trials may be required, and to the place of clinical trials of provinces, autonomous regions and municipalities directly under the food and drug administration and the State food and Drug Administration report.
39th institutions and personnel participating in the clinical trial, violations of regulations or requirements of the applicant changes data, conclusions, and applicants should be location of provinces, autonomous regions and municipalities directly under the food and drug administration and the State food and Drug Administration report. 40th article of in vitro diagnostic reagents for clinical trials, applicants should be location of provinces, autonomous regions and municipal food and drug supervision and Administration Department.
Accept the filing of record food and drug supervision and management departments should be informed of place of clinical trials at the food and drug administration and Planning Department of public health.
State food and drug administration and the provinces, autonomous regions and municipalities directly under the food and Drug Administration needed to supervise and inspect the implementation of clinical trials.
The sixth chapter product registration
41st to apply for registration of in vitro diagnostic reagents, the applicant shall, in accordance with the relevant request submitted to the food and Drug Administration to declare information.
42nd after the food and Drug Administration receives the application form review of declarations, and are made according to the following process:
(A) the application belongs to the mandate of the Department, complete information, meet the review requirements, be admissible;
(B) reporting errors that can be corrected on the spot, shall permit the applicant to be corrected on the spot;
(C) the reporting forms are incomplete or do not meet the review requirements, shall inform the applicant within 5 working days once needs correction of all content, fails to inform the, starting from the day of receipt of the application materials shall be inadmissible;
(D) applications, not part of the mandate of the Department, shall immediately inform the applicant inadmissible.
Food and Drug Administration accept or not to accept an application for registration of in vitro diagnostic reagents, certificate with a special seal and dated in this sector should be accepted or not to accept the notices.
43rd accepts an application for registration of food and drug supervision and management departments should be within 3 working days from the date of acceptance of declarations referred to the technical review of authorities.
Technical review body shall, within 60 working days to complete the second types of in vitro diagnostic reagents registered technical review, within 90 working days to complete the registration of class III in vitro diagnostic reagents the technical review process.
Needs of the external expert review, excluding the time required, technical review of agencies should be required to inform the applicant in writing.
44th technical review of food and drug supervision and management departments in the organization can access to original research materials, and organization of the applicant and the product development and production-related quality management system verification. The territory of class II and class III medical device quality management system registration verification, by the food and drug regulatory agency of provinces, autonomous regions and municipalities, including territory of class III medical device quality management system registration verification, technical review of the food and drug administration by the State agencies notify the appropriate provinces, autonomous regions and municipalities directly under the food and drug administration departments to carry out the verification and, if necessary, participate in the verification.
The provinces, autonomous regions and municipalities directly under the food and drug supervision and Administration Department shall, within 30 days in accordance with the relevant requirements complete system verification.
Technical review of the State food and drug administration institutions in the import category II and class III in vitro diagnostic reagents for technical review, verification of the quality management system is considered necessary, informing the State food and Drug Administration Inspection Agency verification in accordance with requirements of quality management system and, if necessary, technical review of agencies involved in the verification.
Verification time is not included in the review of the quality management system within the time limit. Article 45th require applicant to correct information in the technical review process, technical review of agencies should be told to correct everything at once. The applicant shall, within 1 year of notification's request to provide additional information in accordance with the corrections and technical review body shall, within 60 working days from the date of receipt of the additional information to complete the technical review.
Additional information not included in the review of the applicant within the time limit.
Correction information to the applicant disagrees with the content, you can submit written observations to the appropriate agency for the technical review, state the reasons and provide technical support information.
The applicant fails to submit additional information, terminated by the Agency for the technical review technical review of proposed recommendations that are not registered, after approval by the food and Drug Administration made the decision to refuse to register. Article 46th accepts an application for registration of the technical review of food and drug supervision and Administration Department shall take a decision within 20 working days of the end. To meet the requirements of safe, effective, and approval from the approval decision within 10 working days from the date of issue registration certificate of medical devices, approved technical requirements for products and product specifications to the applicant as an attachment.
To refuse to register, shall state the reasons in writing, and at the same time inform the applicant applied for a review and the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
Medical device registration certificate is valid for 5 years. 47th registration of in vitro diagnostic reagents include licensing and registration matters.
Licensing matters, including product name, package specifications, main components, intended use, product specifications, product descriptions, product's lifetime, imported the production of reagents for in vitro diagnostic address; registration includes the name and domicile of the registered agent name and residence address, territory of in vitro diagnostic reagents for production.
48th for the rare disease and response to emergent public health events in urgent need of in vitro diagnostic reagents, the food and Drug Administration to approve the registration of in vitro diagnostic reagents, require that the applicant completing further work after the product launch, and requirements set out in the registration certificate of medical devices.
49th for accepting an application for registration, any of the following circumstances, the food and Drug Administration made the decision to refuse to register and inform the applicant of:
(A) the applicant to be marketed in vitro diagnostic reagents for safety and effectiveness research and its results could not prove that the product is safe and effective;
(B) false registration information;
(C) the registration documents of confusion, contradiction;
(D) the registration documents and the contents of declaration differs markedly from the project;
(E) other circumstances that are not registered.
50th for accepting an application for registration, applications can be processed before a decision of administrative license, to entertain the application of the food and drug administration permission to withdraw an application for registration and related information, and state the reasons. 51st for accepting an application for registration, there is evidence to show that the registration documents may be false, the food and Drug Administration may suspend approval.
After verification, based on verification conclusions continue to review or make a decision to refuse to register. 52nd on food and drug supervision and Management Department of the applicant disagrees with the decision taken shall be rejected for registration and receipt shall be rejected for registration within 20 working days from the day of notification of the decision, made the decision on the approval of the food and Drug Administration Department of the application for review.
Contents of the application for review is limited to original applications and declarations. Food and drug supervision and Administration Department shall accept the application for review made within 30 working days from the date of decision, and notify the applicant in writing.
Upheld the decision, the food and Drug Administration is no longer accepting applications for review the question once again.
53rd on food and drug supervision and management of the applicant disagrees with the Department's decision to refuse to register, and has been applying for administrative reconsideration or bring an administrative lawsuit, the food and Drug Administration does not accept its application for review. The 54th medical device registration certificate is lost, the registrant should be immediately posted on the media specified in the original Licensing Office declared lost.
Posted missing declaration after expiration of 1 month from the date of, the original issuing authority for replacement, the original issuing authority within 20 working days to be issued retrospectively. Listed 55th in vitro diagnostic reagents, technical requirements and specifications of the products shall be consistent with the contents of the food and Drug Administration approval.
Persons registered with or filing for local market product safety and effectiveness tracking and, if necessary, product technical specification of a requirement, change requests in a timely manner.
56th article body outside diagnosis reagents registered application directly involved applicants and others Zhijian major interests relationship of, food drug supervision management sector should told applicants, and interest relationship people in accordance with legal, and regulations and national food drug supervision management General of about provides enjoys application hearing of right; on body outside diagnosis reagents registered application for review Shi, food drug supervision management sector think belongs to involved public interests of major license matters, should to social announcement, and held hearing.
57th registration occurs after the application review process and approval of patent disputes, should be dealt with in accordance with the provisions of relevant laws and regulations.
The seventh chapter registration changes
Article 58th registered category II and category III in vitro diagnostic reagents, medical device registration form and content changes set out in the annex, registered person shall apply to the registration change, and submitted declarations in accordance with the relevant requirements.
Name and domicile of the registered agent name and address changes, the Registrant shall apply to the registration of registration change; the territory of address changes for the production of in vitro diagnostic reagents, the Registrant shall be in the appropriate register change the license was changed.
Registration certificate and annex containing the contents of the following changes, the applicant shall apply to the registration license changes:
(A) Antigen, antibodies and other major suppliers of materials change;
(B), positive values, or reference interval change detection conditions;
(C) registered product technical requirements set out in the project, indicators, test method for change;
(D) packing specifications, applicable model change;
(E) product storage conditions or change the validity period of the product;
(F) increasing use, such as increasing clinical indications, more types of samples for the determination;
(G) the import of address changes for the production of in vitro diagnostic reagents;
(VIII) other changes that may affect product safety and effectiveness.
The 59th following circumstances don't belong to the application of the provisions of this chapter, shall apply for registration:
(A) the basic reaction mechanism changes;
(B) positive values, or reference interval changes and have new clinical diagnostic significance;
(C) other significant changes that affect product performance. 60th registration change of information to meet the requirements, the food and drug supervision and Administration Department shall, within 10 working days to file medical device registration changes.
Registration change of information are incomplete or do not meet the review requirements, the food and drug supervision and management departments should be told to correct everything at once.
The 61st for license change, institutions should be focused on the technical review section for review and its impact on product performance, an evaluation of the changes whether the product is safe and effective.
Accept license request food and drug supervision and management departments should be in accordance with the technical review of the time limits provided for in the sixth chapter organizations in these measures. 62nd medical device registration change file merge with the original registration certificate of medical devices used, its validity period and the registration of the same.
After obtaining the registered document, registered shall be modified according the changes to product specifications, instructions and labels.
63rd license change the admissibility of applications and approval procedures not specified in this chapter, these measures shall apply to the relevant provisions of the sixth chapter.
Eighth chapter continues to register
64th needs to extend the expiry of registration certificate of medical devices registration, Registrant shall, on the expiry of the current registration certificate of medical devices 6 months ago, to register with the food and Drug Administration to seek an extension, and in accordance with the requirement to report information. Except as provided in this article 65th case, continue registration applications received food and Drug Administration should be made before the expiry of the current registration certificate of medical devices the decision to approve the extension.
Fails to make a decision, considered to approve the extension.
65th under any of the following circumstances, refuse to continue registration:
(A) for applications for registration is not submitted within the deadline extended;
(Ii) in vitro diagnostic reagents for mandatory standards have been revised or new standard, reference material, which cannot meet the requirements of the new in vitro diagnostic reagents;
(C) for rare disease and response to emergent public health events in urgent need of in vitro diagnostic reagents, registration requested by the Department at the time of approval, the registrant is not completed within the prescribed time of medical device registration form containing the matters.
66th in vitro diagnostic reagents continue accepting an application for registration and approval procedures not specified in this chapter, these measures shall apply to the relevant provisions of the sixth chapter.
Nineth part record
67th article types of in vitro diagnostic reagents prior to production, should go through the product record. Article 68th in vitro diagnostic reagents for the record, the record shall, in accordance with the medical device regulatory filings that the Nineth of provisions of legislation.
Record information to meet the requirements of, the food and drug supervision and Administration Department shall record on the spot; filings are incomplete or do not meet the requirements, should be told to correct everything at once, after correction for the record by record people.
Record of in vitro diagnostic reagents, the food and drug supervision and management departments should make the record voucher in accordance with requirements, and record information posted on the website of the information in the table to be published. 69th record of in vitro diagnostic reagents, filing information sheet posted in content and record changes in technical requirements, the filing shall provide information and relevant documents, make changes to the original filing departments record information.
Record information meets the requirements of form, the food and Drug Administration changes should be posted on the changes in the information, record data archive.
70th filed adjustment of the management category of in vitro diagnostic reagents, the filing shall take the initiative to cancel the original filing to the food and Drug Administration Department; management category adjusting as class II or class III in vitro diagnostic reagents, apply for registration in accordance with this regulation.
Supervision and administration of the tenth chapter
71st State food and Drug Administration is responsible for the national in vitro diagnostic reagents registered with the supervision and management of the record in the local food and drug supervision and management departments in vitro diagnostic reagents registration and filing work of supervision and guidance.
72nd of provinces, autonomous regions and municipalities directly under the food and drug regulatory agency responsible for the administration of in vitro diagnostic reagents registered with the supervision and management of the record, and organization to carry out supervision and inspection, and relevant information submitted to the State food and drug administration in a timely manner.
73rd of provinces, autonomous regions and municipalities directly under the food and drug supervision and management departments in accordance with the principle of territorial management of imported reagents for in vitro diagnostic agents registered conduct day-to-day supervision and management associated with the record.
74th district, the municipal food and drug supervision and management departments should periodically check the records of, and to provinces, autonomous regions and municipalities directly under the food and drug supervision and management departments to submit relevant information.
75th registered in vitro diagnostic reagents have laws and regulations should be written off, or registration certificate unexpired term but offered cancellation of a registered person, the food and drug supervision and management departments should be written off in accordance with law, and to the public. 76th registered in vitro diagnostic reagents, the management category changed from high class to lower classes, within the period of validity of registration certificate of medical devices remains in force.
If continuation of the registered person shall, on the expiry of the current registration certificate of medical devices 6 months ago, in accordance with the changed category apply to the food and Drug Administration for an extension of registration or filing. In vitro diagnostic reagents ' Administration categories changed from low class to high class, registered persons should be in accordance with the provisions of the sixth chapter of these measures, in accordance with the category of the change to the food and drug supervision and management departments registration.
The State food and drug administration in the management category adjustment should be made to adjust the time limit stated in the notice.
77th of provinces, autonomous regions and municipalities directly under the food and drug regulatory agency violates the measures required to implement registration of in vitro diagnostic reagents, by the State food and Drug Administration ordered corrected; fails, the State food and Drug Administration notice to revoke the registration certificate of medical devices directly.
78th food and drug supervision and Management Department, technical institutions and their staff, the applicant or for the record submitted by the test data and technical secrets confidential.
The 11th chapter legal liability
The 79th provision of false information or take other dishonest means to achieve registration of medical devices, in accordance with the regulation on supervision and administration of medical devices shall be punished by the 64th article of.
Providing false information when filing, in accordance with the regulation on supervision and administration of medical devices of the 65th of the second paragraph of article shall be penalized.
80th article forge, alter, sell, lease or lend the registration certificate of medical devices, in accordance with the regulation on supervision and administration of medical devices shall be punished by the 64th article of.
81st article violates these rules, not according to changes of in vitro diagnostic reagents for the record of the first kind or type II and class III in vitro diagnostic reagents for change of registration, in accordance with the supervision and administration of medical devices Ordinance relating to penalties that are not filed.
82nd article violates these rules, not according to in vitro diagnostic reagents registered license change, in accordance with the medical devices regulatory Ordinance without obtaining the registration certificate of medical devices will be punished.
83rd applicant are not in accordance with the regulation on supervision and administration of medical devices and clinical trials as provided herein, by the food and drug administration departments at or above the county level shall be ordered to correct, may be fined a maximum of 30,000 yuan in serious cases, clinical trials should cease immediately.
12th chapter supplementary articles
84th in vitro diagnostic reagents for registration or filing as a single agent or a single Kit, a registration or filing elements can include different pack sizes.
85th medical instrument registration certificate format developed centrally by the State food and drug administration.
Presentation of the registration certificate number: X1 instrument x2xxxx3x4xx5xxxx6.
Of which:
X1 for registration and approval of Department seat of the abbreviations:
Domestic class III in vitro diagnostic reagents, import of class II and class III in vitro diagnostic reagents for "country";
Second class in vitro diagnostic reagents for the registered seat of the competent departments of provinces, autonomous regions and municipalities directly under the abbreviation;
X2 for registration form:
"Quasi" applies to the territory of in vitro diagnostic reagents;
"Into" Word applies to imports of in vitro diagnostic reagents;
"Given" Word as applied to Hong Kong, Macao, Taiwan area of in vitro diagnostic reagents;
Xxxx3 for the first registration year;
X4 for the product management category;
Xx5 classification code for the product;
Xxxx6 to register the serial number for the first time. Continued registration of xxxx3 and xxxx6 numbers are not changed.
Adjustment of the product management category, should be renumbered accordingly.
86th article types of in vitro diagnostic reagents presentation of the registration certificate number: X1 instrument xxxx2xxxx3.
Of which:
X1 seat of the filing Department abbreviations:
Import the first types of in vitro diagnostic reagents for "country";
Domestic first class seat of in vitro diagnostic reagents for the record departments of provinces, autonomous regions and municipalities directly under the abbreviation abbreviation plus seat area of the municipal boundaries (when there is no corresponding municipal administrative area divided into districts, only for the provinces, autonomous regions and municipalities directly under the abbreviation);
Xxxx2 for the filing year;
Xxxx3 to record serial number.
87th in vitro diagnostic reagents for emergency approval and innovation for special examination set by the State food and Drug Administration medical emergency procedures and innovative medical devices special approval procedures.
88th according to need, the State food and Drug Administration may appoint a province, autonomous region, or municipality directly under the food and drug administration or technical bodies, relevant community organizations undertake specific work related to registration of in vitro diagnostic reagents.
89th in vitro diagnostic reagents for registration fees, fees in accordance with the relevant provisions of financial, pricing departments under the State Council. 90th these measures shall come into force on October 1, 2014.
