On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.
On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
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.
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.
Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.
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