Chapter I General Provisions
Article 1 The Provisions is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, with a view to standardizing the administration on registration and filing of in-vitro diagnostic reagents and ensuring the safety and effectiveness of in-vitro diagnostic reagents.
Article 2 All in-vitro diagnostic reagents sold and used within the territory of the People's Republic of China shall apply for registration or filing according to the Provisions.
Article 3 The in-vitro diagnostic reagents mentioned herein refer to in-vitro diagnostic reagents administered as medical devices, including reagents, reagent kits, calibrators, control materials, etc. for in-vitro examination of specimens derived from human body in the course of disease forecast, prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation, which can be used independently or in combination with instruments, devices, equipment or systems.
The in-vitro diagnostic reagents used for blood screening and the in-vitro diagnostic reagents labeled by radionuclide, which are subjected to drug administration, do not belong to the administration scope of the Provisions.
Article 4 In-vitro diagnostic reagent registration refers to the prescribed procedures conducted by the food and drug regulatory department upon an application submitted by the registration applicant to decide whether the medical device to be marketed can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.
In-vitro diagnostic reagent filing is a process that the filing entity submits the filing documents to the food and drug regulatory department and the food and drug regulatory department files the filing documents submitted by the filing entity.
Article 5 The in-vitro diagnostic reagent registration and filing shall be conducted under the principles of publicity, equity and justice.
Article 6 Class I in-vitro diagnostic reagents are subject to filing administration and class II and class III in-vitro diagnostic reagents are subject to registration administration.
To apply for filing of class I in-vitro diagnostic reagent, the filing entity shall submit the filing documents to the food and drug regulatory department of the city consisting of districts .
Class II in-vitro diagnostic reagents shall be reviewed by the food and drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government, and the medical device registration certificate shall be issued after approval.
Class III domestic in-vitro diagnostic reagents shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
To apply for filing of import class I in-vitro diagnostic reagents, the filing entity shall submit the filing documents to China Food and Drug Administration.
Import class II and class III in-vitro diagnostic reagents shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
The in-vitro diagnostic reagents from Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China shall be registered and filed by reference to the import medical devices.
Article 7 Where a registration applicant or filing entity of an in-vitro diagnostic reagent brings the products to the market in his own name, he shall take responsibilities for the product.
Article 8 The food and drug regulatory department shall publicize relevant information on in-vitro diagnostic reagent registration and filing promptly in accordance with laws. The applicant can look up the approval progress and relevant results as well as the public can look up the result of approval.
Article 9 The State encourages the research and innovation of in-vitro diagnostic reagents, implements special review for innovative medical devices, accelerates the popularization and ap...
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