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
License Transfer: License transfer is possible and considered as license amendment.
Authorized Representative: An authorized representative is required to register in China.