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How to fill in the business place and business situation in the record form of the second class medical device business?
Hello, dear, 1. The content of the business premises project is: consistent with the content of the residence project in the business license.

2. Conditions of the business premises: (1) Fill in the nature of the business premises: for lease or personal use.

(2) Fill in facilities and equipment: telephones, computers, display cases, lockers, shelves, office desks and chairs and other necessary equipment related to operating products.

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 machine 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!