How to determine the classification of medical devices
Generally from the "medical device classification directory" 2002 version of the query.
From the "Medical Device Supervision and Management Ordinance" (State Council Decree No. 276)
Article 5 The State shall classify and administer medical devices.
The first category refers to medical devices that are routinely managed enough to ensure their safety and effectiveness.
The second category refers to the medical device whose safety and effectiveness should be controlled.
The third category refers to the implantation of the human body; used to support, maintain life; the human body is potentially dangerous, its safety, effectiveness must be strictly controlled medical equipment.
Medical device classification directory by the State Council Drug Administration Department of medical equipment classification rules, the State Council health administrative departments to develop, adjust and publish.
First, in accordance with the definition of medical devices to determine whether the scope of medical equipment.
Second, in accordance with the "medical device classification rules" to determine the basic principles.
Third, in accordance with the "medical device classification directory" to find specific categories
Fourth, refer to the Food and Drug Administration website published in the specific product classification file or its website to find the registration data for this product as a reference
5, if the above can not be determined, one or two products can be consulted to the local provincial bureau. Overseas and three categories can be to the Food and Drug Administration Standard Management Center for consultation.
"Medical device classification directory" can be found, but also according to the use of medical devices to see. State Food and Drug Administration.
