Medical Device Registration

Medical Device RegistrationAccording to statistics, the scale of China's medical device market has exceeded RMB 500 billion in 2018, and is expected to exceed RMB 1 trillion in 2023. In 2019, the State Food and Drug Administration of China accepted 5,593 applications for registration of imported medical devices, an increase of 32% compared to 2018, and the growth momentum has not weakened. Imported medical devices are accelerating their entry into the Chinese market, which is also bringing huge benefits to global medical device companies. Business opportunities.


Facing the fast-growing Chinese market and China nmpa's continuous improvement and adjustment of policies and regulations, you need an agency registration company with sufficient experience in China, and TOSUN is very confident that with more than 20 years of experience, it can help you quickly enter China's medical devices market.




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Notes

  • Do imported medical devices need to have Chinese labels?
    Imported medical devices should have Chinese instructions and Chinese labels. The instructions and labels shall meet the requirements of the Regulations on the Supervision and Administration of Medical Devices and the requirements of relevant mandatory standards. The instructions shall state the origin of the medical device and the name, address and contact information of the agent. No Chinese instructions, Chinese labels or instructions or labels that do not comply with the provisions of this Article shall not be imported.

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