Legal analysis: the first class of medical device products for the record, by the filer to the municipal people's government in charge of drug supervision and management of the location of the municipal people's government to submit the filing information.
Processing materials in general,
1. "Class I Medical Device Filing Form" (the original original (collected) 1, 1 electronic copy)
2. Safety Risk Analysis Report (1 electronic copy, 1 copy)
3. Product Technical Requirements (1 electronic copy, 1 photocopy)
4. Product Inspection Report (1 electronic copy, 1 photocopy)
4. (1 electronic copy, 1 copy)
5. Clinical evaluation data (1 electronic copy, 1 copy)
6. Product specifications and minimum sales unit labeling design samples (1 electronic copy, 1 copy)
7. Production and manufacturing information (1 electronic copy, 1 copy)
8. Proof of the documents (copy of business license, copy of organization code certificate)
9. (1 electronic copy, 1 copy)
9. Declaration of Conformity (1 original (collected), 1 electronic copy)
10. Proof of authorization of the operator and the original and copy of the operator's ID card (1 original (collected), 1 electronic copy)
Legal basis: "Regulations on Supervision and Administration of Medical Devices of the People's Republic of China", Article X, paragraph 1 (b). Supervision and Administration of Medical Devices Regulations" Article XIII of the first class of medical devices to implement product record management, the second class, the third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety and effectiveness of the responsibility according to law.