There are two requirements:
1, the business premises should be used area of not less than 40 square meters, the use of legal entity branches of the business premises should be used area of not less than 25 square meters (except across the municipal setup); business hearing aids, the use of the business premises should be used area of not less than 25 square meters; business contact lenses and care solution, the use of the business premises should be used area of not less than 10 square meters. Not less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
The country has a strict classification of medical devices, and Class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, refers to the implantation of the human body, used to support, maintain life, the human body has the potential danger, its safety, effectiveness must be strictly controlled medical devices.
Expanded Information
Registered Class III medical device company's business scope:
Sales of medical devices Class III: medical electronic instruments and equipment, medical optical apparatus, instruments and endoscopic equipment, medical magnetic **** vibration equipment, medical X-ray equipment, operating room, emergency room, diagnostic and treatment room equipment and apparatus; Class II: Clinical testing and analysis instruments. Sales of computer software and auxiliary equipment, electronic products, cultural goods, handicrafts (excluding cultural relics), construction materials, mechanical equipment, furniture, instruments and meters.
Retail injection and puncture instruments, medical polymer materials and products, clinical test and analysis instruments, in vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilization equipment and apparatus.
Baidu Encyclopedia - Class III Medical Devices