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Do RF instruments need medical qualification?
Hello, RF instruments need medical qualification.

No medical qualification supervision department has reported it.

According to the Classification Catalogue of Medical Devices, RF therapeutic devices belong to the third category of medical devices.

Radio frequency therapeutic devices belong to the third category of medical devices, and they need to go through the examination and approval procedures such as medical device registration certificate before they can be put on the market.

Conditions for registering Class III medical devices: 1. The enterprise has obtained industrial and commercial registration in accordance with relevant regulations; 2. The declared products have been identified as Class III medical devices; 3. The technical requirements for medical devices of the products applied for have been compiled and passed the pre-evaluation.