The State Drug Administration in charge of The Classification of Medical Devices

2016/1/18 17:20:56

When the classification of medical devices cannot be determined according to the Catalogue for the Classification of Medical Devices.

Pre-classified by provincial drug supervision and administration departments in accordance with the Rules for the Classification of Medical Devices,and reported to the State Drug Administration for approval.

Medical devices are divided into two categories: diagnostic and therapeutic.Diagnostic includes: physical diagnostic instruments, imaging), analytical instruments, electrophysiology, etc.

Therapeutic includes: general surgical instruments, light-guided surgical instruments, assisted surgical instruments, radiation therapy machines, other categories: microwave, hyperbaric oxygen, ......

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