General situation of handling materials:
1. Record Form for Class I Medical Devices (1 original (received) and 1 electronic)
2. Safety risk analysis report (1 electronic parts and 1 copy)
3. Product technical requirements (1 electronic parts and 1 copy)
4. Product inspection report (1 electronic parts and 1 copy)
5. Clinical evaluation data (electronic version 1 copy, copy 1 copy)
6. Product description and minimum sales unit label design sample (1 electronic parts and 1 copy)
7. Manufacturing information (1 electronic parts and 1 copy)
8. Certification documents (copies of business license and organization code certificate) (electronic part 1 copy, electronic part 1 copy)
9. Declaration of conformity (1 original (received) and 1 electronic parts)
10. Original and photocopy of the agent's authorization certificate and agent's ID card (original 1 copy (received), electronic part 1 copy).
Legal basis: Article 13 of the Regulations on the Supervision and Administration of Medical Devices implements product filing management for Class I medical devices and product registration management for Class II and Class III medical devices.
Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.