Two related medical personnel (college degree or above)
Including in vitro diagnostic reagents: 100 m2 registered address +60 m2 warehouse +20 m3 cold storage.
Category 3 does not contain in vitro diagnostic reagents, and it needs 60 square meters warehouse and 30 square meters business area.
The third category (including acupuncture kits and anesthesia kits) needs 100 square warehouse and 30 square business area.
The inspector in charge must be a doctor, director or have worked for 3 years.
What materials are needed:
Application form for medical device business enterprise license
Registration Form of Application Materials for Medical Device Business License
Original business license; Official seal and code certificate
Id card, education or title certificate of the quality manager/person in charge of the proposed enterprise.
A copy of the address and location map, floor plan, house title certificate or lease agreement of the registered place and warehouse of the proposed enterprise.