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.
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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.