What procedures do individual industrial and commercial households need to provide when applying for a class I medical device business, and how to fill in the business scope?

Hello! Apply to the US Food and Drug Administration for filing according to your business scope.

Information to:

1, written application

2. A full set of business certificates of the enterprise.

3 resumes, education certificates, health certificates and letters of appointment of legal persons, responsible persons and quality administrators.

4, employee roster organization and department description

5. Description of business scope and mode of operation

6, warehouse, business premises plan, layout, proof of property rights

7, facilities and equipment directory

8. Management system procedures

9, business variety registration certificate, registration form

Business scope directly write the product number:

Category I: 680 1 Basic surgical instruments

6802 microsurgical instruments

6803 neurosurgical instruments

6804 ophthalmic surgical instruments

6805 Otolaryngology Surgical Instruments

6806 oral surgical instruments

6807 thoracic cardiovascular surgical instruments

6808 abdominal surgical instruments

6809 surgical instruments for uroanorectal surgery

68 10 plastic surgery (orthopedic surgery) surgical instruments

68 12 Obstetrics and Gynecology Surgical Instruments

68 13 family planning surgical instruments

68 16 burn (plastic surgery) surgical instruments

6820 universal diagnostic instrument

6827 Chinese medicine equipment

The business scope is directly numbered, and the sales method is subject to myself, which can be written as retail and wholesale.

I hope I can help you!