The administrative provisions of medical devices
1. Medical devices:
1)Instruments, equipment, apparatus, materials or other items used in the human body, either alone or in combination, including the required software;
2)Role: the role of the human body for use on the surface of the human body and in vivo is not obtained by means of pharmacology, immunology or metabolism, but may have these means of Involvement and play a certain auxiliary role;
3)Purpose of use:
① Prevention, diagnosis, palliation, guardianship of disease;
② Diagnosis, treatment, guardianship, palliation, compensation of injury or disability;
③ Study of anatomical or physiological processes, substitution, modulation;
④ Pregnancy control.
2.SFDA
Responsible for the national, county-level and above the Drug Administration is responsible for local medical device regulation.
3. Classification and Approval:
Medical devices are divided into one, two and three categories according to their safety and effectiveness size.
1) start the first class of medical device manufacturing or business enterprises, the provincial Drug Administration for the record.
2) to start the second and third class of medical equipment production or business enterprises, the provincial Drug Administration for approval and licensing, business registration.
3) Medical device manufacturers in the production of medical equipment products to obtain a certificate of registration, before production.
4) The first import of medical devices, must obtain SFDA import registration certificate before applying for import procedures.
5) Medical device product registration certificate is valid for four years. Within six months before the expiration of the validity period, apply for re-registration.