Export II& to China in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Rules for the Classification of Medical Devices, the Catalogue of Medical Devices Classification, the Measures for the Registration and Administration of Medical Devices and the Measures for the Registration and Administration of in Vitro Diagnostic Reagents; The overseas manufacturer of Class III medical devices shall, by its representative office established in China or the designated enterprise legal person in China as an agent, submit registration application materials to the National Bureau. The registration of medical devices in Hong Kong, Macao and Taiwan shall be handled by referring to imported medical devices.

1. Those who produce medical devices without licenses shall have their illegal gains confiscated, as well as relevant business materials, tools and equipment. Whoever illegally produces a product with a value of more than 10,000 yuan shall concurrently be fined not less than 10 times but not more than 20 times the value of the product; If the circumstances are serious, the application for medical device license submitted by the relevant responsible person and enterprise shall not be accepted within 5 years;

2, provide false information or take other deceptive means to obtain medical device registration certificate, production license, revoke the license, and impose a fine of more than 50,000 yuan and less than 100,000 yuan, within 5 years do not accept the medical device license application made by the relevant responsible person and unit.

3, forging, altering, trading, leasing, lending medical device license, confiscate or revoke the license, confiscate the illegal income; If the illegal income is not less than 10,000 yuan, he shall be fined not less than three times but not more than five times the illegal income; If it constitutes an act violating the administration of public security, the public security organ shall punish it for the administration of public security according to law.

1. Copy of business license of domestic agent enterprise

2, legal representative, responsible person ID copy

3, production site plan

4, product main raw materials, material list, production process, equipment list

5, product registration test sample

6, overseas registered enterprise qualification documents

7, Product registration certificate/license certificate

8, overseas production enterprise system certificate

9. Proof of product sales abroad

10. Power of Attorney for appointed agent

11. Clinical Trial Data

12, the original product manual and label sample (Note: If you need to do on-site audit of overseas manufacturers, you need further information of overseas manufacturers)

Imported II& Class III expected period: 1 – 2 years (excluding clinical trial time)

Registration certificate is valid for 5 years, application for renewal 6 months before expiration