Class 1 is approved by the Drug Administration at the prefecture level
Class 2 is approved by the Drug Administration at the provincial level
Class 3 devices are approved by the State Drug Administration.
What you mean by affiliation is to sell the manufacturer's brand or paste your brand. Medical device labeling procedures are very troublesome, and manufacturers do not necessarily give you a labeling production. Suggestions: choose a good product, find a good manufacturer, first take the region's agent, and then consider the labeling production after the sales volume.
Expanded Information:
One, the approval of three types of medical devices license conditions:
1, the business premises should be no less than 40 square meters, the use of legal entity branches of the business premises should be no less than 25 square meters (except for the set up of the municipalities across the region); business hearing aids, the use of the business premises should be no less than 25 square meters; contact lenses and nursing fluids, the business premises should be no less than 25 square meters; contact lenses and nursing fluids, the business premises should be no less than 25 square meters; contact lenses and nursing fluids, the business premises should be no less than 25 square meters. And care solution, the business premises should be no 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.
3, quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operating single-use sterile medical devices, there should also be more than one holding a medical device quality management system internal auditor certificate of the internal auditor and other relevant application conditions.
Two, what are the third class of medical devices?
Used for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring systems, artificial crystals, invasive endoscopy, ultrasound scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, X-ray therapeutic equipment, more than 200mA X-ray machine, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valves, artificial kidney, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment.