MEDICAL DEVICE REGISTRATION AND APPROVAL IN China

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 update: December 2022

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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