Administrative Measures for the Registration of In Vitro Diagnostic Reagents
Administrative Measures for the Registration of In Vitro Diagnostic Reagents
Administrative Measures for the Registration of In Vitro Diagnostic Reagents
Order of the China Food and Drug Administration No.5
July 30, 2014
The Administrative Measures for the Registration of In Vitro Diagnostic Reagents, adopted at the executive meeting of the China Food and Drug Administration on June 27, 2014, are hereby promulgated for implementation as of October 1, 2014.
Zhang Yong, Minister
Administrative Measures for the Registration of In Vitro Diagnostic Reagents
Chapter I General Provisions
Article 1 The Administrative Measures for the Registration of In Vitro Diagnostic Reagents (hereinafter referred to as the "Measures") are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, in order to standardize the administration of the registration and record-filing of in vitro diagnostic reagents and ensure the safety and effectiveness of in vitro diagnostic reagents.
Article 2 To sell or use in vitro diagnostic reagents within the territory of the People's Republic of China, applications for registration shall be filed or record-filing formalities shall be gone through in accordance with the Measures.
Article 3 For the purpose of the Measures, in vitro diagnostic reagents refer to in vitro diagnostic reagents administered as medical devices, including reagents, reagent kits, calibrators and quality controls for in vitro examination of specimens derived from the human body in the course of disease forecasting, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation, which can be used independently or in combination with instruments, devices, equipment or systems.
In vitro diagnostic reagents used for blood screening and in vitro diagnostic reagents labeled by radionuclides, which are subject to drug administration, do not fall within the administration scope of the Measures.
Article 4 Registration of in vitro diagnostic reagents refers to the process in which the food and drug administration, upon an application filed by the registration applicant, and according to legal procedures, decides whether to approve such application after a comprehensive evaluation of the research on the safety and effectiveness of the in vitro diagnostic reagents to be marketed by the applicant and its results.
Record-filing of in vitro diagnostic reagents is a process in which a record-filing applicant submits the record-filing materials to the food and drug administration, which files the filing materials submitted for future reference.
Article 5 The registration and record-filing of in vitro diagnostic reagents shall be conducted under the principles of publicity, equity and justice.
Article 6 Class I in vitro diagnostic reagents are subject to record-filing administration and class II and class III in vitro diagnostic reagents are subject to registration administration.
To apply for the record-filing of class I in vitro diagnostic reagents, the record-filing applicant shall submit the filing materials to the food and drug administration of the city divided into districts.
Class II in vitro diagnostic reagents shall be examined by the food and drug administrations of provinces, autonomous regions and municipalities directly under the Central Government, and medical device registration certificates shall be issued after approval.
Class III domestic in vitro diagnostic reagents shall be examined by the China Food and Drug Administration (CFDA), and medical device registration certificates shall be issued after approval.
To apply for the record-filing of imported class I in vitro diagnostic reagents, the record-filing applicant shall submit the filing materials to the CFDA.
Imported class II and class III in vitro diagnostic reagents shall be examined by the CFDA, and medical device registration certificates shall be issued after approval.
The in vitro diagnostic reagents from Hong Kong, Macao and Taiwan shall be registered and filed for the record by reference to the imported in vitro diagnostic reagents.
Article 7 Where a registrant or record-filing applicant of an in vitro diagnostic reagent brings products to the market in its own name, it shall take legal liability for the products.
Article 8 Food and drug administrations shall publicize the relevant information on the registration and record-filing of in vitro diagnostic reagents promptly in accordance with the law.
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