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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including China, to expedite the preparation of your medical device or IVD registration application.

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

LICENSALE TRANSFER: License transfer is possible and considered as license amendment.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register in China.

Last updated on October 29, 2020.

 

Other Central & East Asia Countries:

Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Taiwan, Tajikistan, Uzbekistan

 

 

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