To sell medical devices on the Internet, the following conditions must be met:
1, to obtain a license certificate issued by the State Food and Drug Administration for the sale of drugs and medical devices;
2, to obtain a license certificate issued by the Ministry of Information Industry for the sale of drugs and medical devices online.
In other words, online sales of medical devices are subject to both food and drug regulatory authorities and network regulatory authorities.
The following application for a medical device license some of the site conditions, you can look at, it is more difficult to meet with the individual.
2.1 has a relatively independent and business scale, business scope of the appropriate business premises, the premises should be spacious, clean and bright. Business premises should be separated from the living area, shall not be set up in residential housing. Franchise business premises using an area of not less than 40 square meters, part of the medical equipment supermarkets, pharmacies should have a relatively independent business area. Check the real estate license or lease contract, see the site, field measurements, according to the general principles of scoring.
2.2 Medical device stores, there should be a counter or shelves appropriate to the scale and scope of business. Businesses operating hearing aid business premises should be set up: reception room, medical examination room, hearing test room and fitting room, and have good environmental and health conditions, should be equipped with professional hearing test equipment or instruments, at least should include: with the air bone conduction test function audiometer, tuning fork, otological examination instruments and for hearing aid commissioning of special equipment. Operating household physical therapy and rehabilitation equipment business, should be in the experience and business premises in a prominent position to post household physical therapy and rehabilitation equipment instructions for the use of warning publicity signage, announced the food and drug regulatory authorities, the industry and commerce administration departments to report the phone number. Look at the site, access to property certificates or lease contracts, according to the general rules of scoring, shall not exceed the scope of business.
2.3 Enterprises in accordance with the actual situation of operating medical devices, set up with the scale of operation and business varieties appropriate warehouse. Warehouse can not be located in residential housing. Warehouse should be clean and sanitary, doors and windows intact, the ground level, should have temperature and humidity meter, shelves, pads, security lighting, fire, ventilation and other infrastructure, as well as the necessary dust, moisture, pollution and pest control, rodent, mildew and other measures. Operation of products with special storage condition requirements, there should be appropriate facilities and equipment, and operational records and status labeling. Warehouse should be clearly marked: pending inspection area (yellow labeling), qualified products area (green labeling), substandard products area (red labeling), different varieties, batches are stored separately, inventory space card is clear, the account, the goods, the card is consistent. And the establishment of product storage and maintenance records. Part-time medical device business stores, medical device products should be set up in a separate area of stacking. Check the property license or lease contract and see the site. Not subregional deduction of 10 points, no obvious labeling deduction of 5 points, draw two products, there is a product account, material, card does not match the 10 points, part-time business products, found a separate stacking deduction of 5 points.