Mechanical preparation number refers to the medical device or health effects of the cream and other products of the approval lot number. It is a medical device product. Does not belong to the drug, belongs to the medical device. It is a medical device with a low degree of risk, the implementation of national routine management can ensure its safety and effectiveness. Measurement of the clinical efficacy can be written directly in the manual, are after the clinical observation of the test. The product safety is higher, are after the State Food and Drug Administration for the record.
Mechanical products on the production workshop and efficacy have strict requirements, there must be a special purification workshop, but also through the medical device special system certification, labeled with the mechanical products have a certain ability to repair the special skin population can also be used, and can be sold in pharmacies, hospitals.
Expanded informationMedical devices are divided into three categories
The first category refers to the routine management is sufficient to ensure its safety, effectiveness of medical devices.
The second category refers to the safety and effectiveness of medical devices should be controlled.
The third category refers to the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Baidu Encyclopedia-Pharmaceutical Device Word