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.
Last updated on November 2nd, 2021.
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, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan
For detailed device-specific compliance information for each market, including China, to expedite the preparation of your medical device or IVD registration application.
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