Medical Device Registration and Approval in China

General country-specific regulatory information is provided on this page for medical device registration and approval in China.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in China

Regulatory Authority: National Medical Products Administration (NMPA)

Classification System: Medical Devices & IVDs: Class I/II/III

Timeframe: The medical device registration process in China takes about 18 months.

Special Requirements:

Audit: Manufacturing inspection is required in most cases for Class II and III, depending on the type of product and size of the manufacturer. Not required for Class I.

Local Tests/Permit: Yes – Safety and effectiveness testing such as IEC and EMC tests.

Clinical Evaluation or Studies: Yes – Only applicable for Class II and III. However, NMPA has published the complete list (catalogue) of medical devices exempted from the clinical trial.

Local Fees (New Application):

Medical Devices/IVDs (Class II) – US$ 31,300

Medical Devices/IVDs (Class III) – US$ 45,800

Local Fees (Manufacturer): N/A

License Validity: 5 Years

License Transfer: License transfer is possible and considered as license amendment.

Authorized Representative: An authorized representative is required to register in China.

Other Central & East Asia Countries: Afghanistan, IndiaJapanKazakhstanKyrgyzstanNepalRussiaSouth KoreaSri LankaTaiwanTajikistanUzbekistan

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For detailed device-specific compliance information for each market, including China, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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