Tag Archive for: China

China NMPA Adds 47 Products to Clinical Trial Exemption List

China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.

China CMDE Supplementary Documents Submission Deadline Extended

On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.

China Continues to Implement UDI of Medical Devices with Third Batch Release

The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.

China’s NMPA Begins Issuing Registration Certificates Electronically

On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.

China’s Green Pathway Registration for Innovative Medical Devices

China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

CHINA: REGULATORY AND COMMERCIAL UPDATES

The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.

Submission Changes in China: ToCs and the eRPS

Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS

Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.

CHINA CHANGES CLINICAL DATA REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION

The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.