According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Registration and Administration of Medical Devices, Class I medical device products shall be filed, and the applicant shall submit the filing information to the municipal drug regulatory department of the district where the applicant is located. The overseas production enterprises that export Class I medical devices to the territory of China shall have their representative offices set up in the territory of China or appoint an enterprise legal person within the territory of China as an agent to submit information for the record to the National Bureau. Among them, the filing of medical devices in Hong Kong, Macao and Taiwan shall be handled with reference to imported medical devices.

For independent production, the production enterprise shall apply for the product filing certificate and the production filing certificate;

Where production is commissioned, the entrusting party shall apply for the product record certificate and the production record certificate, and the entrusted enterprise shall have the corresponding production record certificate;

The imported products shall be authorized by the domestic agent of the overseas production enterprise to apply for the product filing certificate.

1. Copy of business license

2, legal representative, responsible person ID copy

3, production, quality and technical person in charge of identity, education, title certificate copy

4, production management, quality inspection positions of employees education, title list

5, production site certification documents, there are special production environment requirements should also submit facilities, environmental certification documents

6, production site plan (workshop, laboratory, warehouse)

7, the main raw materials, material list, production process, equipment list

8. Qualification Documents of overseas enterprises

9, the product in overseas filing/registration certificate (if overseas does not belong to the medical device supervision, provide the manufacturer system certificate)

10, product sales certificate abroad

11. Power of Attorney for appointed agent

12, the original product manual and label sample (Note: 3-6 items, imported products do not need to provide; 8-12 items, domestic products do not need to provide.)

1, domestic class I expected cycle: 1-3 months, individual region factory conditions meet the premise of 1 month to complete

2. Expected period of import type I: 3 months