RAPS Convergence 2022

China NMPA issued the "Checkpoints of Common Violations of Regulations in the Production, Business Operation, and Usage Quality of Medical Aesthetic Devices" on November 25, 2022. It mandates local MPA entities to strengthen the supervision and inspection of aesthetic devices based on this Notice. Overseas manufacturers shall be aware of these regulation checkpoints. Due to the high demand of quality aesthetics medical devices, China aesthetic market has been growing rapidly. As a result, the violations by clinics, distributors and manufacturers have also increased. We listed some violation situations in production phase for your reference, more details can be found in the Notice:

1. Production of Class II and Class III medical devices that have not obtained a medical device registration certificate
2. Production of medical devices that do not meet mandatory standards or do not meet the product technical requirements (PTRs) of registered device
3. Failure to organize production with the PTR of registered product, or failure to establish a QMS based on related regulations
4. Changes in production conditions may affect the safety and effectiveness of products, and production is not reported in accordance with the provisions
5. Production of medical devices whose instructions for use and labels do not comply with regulations
6. Medical device registrants' manufacturers fail to carry out adverse event monitoring of medical devices in accordance with regulations, fail to report adverse events as required, or do not cooperate with adverse event investigations conducted by medical device adverse event monitoring technical institutions, departments responsible for drug supervision and administration, and health authorities
7. Production of Class II and Class III medical devices beyond the production scope specified in the medical device production license
8. Production of Class II and Class III medical devices at an unlicensed production site
9. Substantially changing the design, raw materials, production process, scope of application, method of use, etc. without authorization, and may affect the safety and efficacy of the medical device
10. ……

Please also be aware that starting from April 1, 2024, radiofrequency devices or RF devices and RF skin devices classified under classification code 09-07-02, shall not be produced, imported, or sold without obtaining medical device registration certificates.

If your product is impacted by any of lifecycle checkpoints in production, business operation and usage quality phase, please email me for a chat.

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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