The use of medical devices and validity period

Medical device product registration certificate is valid for four years. Within six months before the expiration of the validity period, apply for re-registration.

Medical devices according to its safety and effectiveness of the size of one, two, three categories.

1, the opening of the first class of medical equipment production or business enterprises, the provincial Drug Administration for the record.

2, the opening of the second medical education | net editing, three types of medical equipment production or business enterprises, the provincial Drug Administration for approval and licensing, business registration.

3, medical device manufacturers to obtain a certificate of registration for the production of medical device products before production.

4, the first import of medical devices, must obtain SFDA import registration certificate before applying for import procedures.

Expanded Information:

Note:

Medical device instruction manuals and labels should be the same as the registered or filed by the relevant The content of the medical device labeling should be consistent with the relevant content of the instruction manual.

Medical device instructions and labels on the name of the disease, professional terminology, diagnosis and treatment process and results of the expression, should be used in the national unity of the special vocabulary issued or standardized, the unit of measurement should be in line with the provisions of the relevant national standards.

Medical device instructions and labels used in the symbols or identification of color should be consistent with the provisions of relevant national standards, no relevant standards, the symbols and identification of color should be described in the instructions.