Tag Archive for: NMPA

China NMPA Updates Compulsory Standards for Medical Devices

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.

China NMPA Updates Classification of Sodium Hyaluronate Products

On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.

China’s NMPA Publishes Classification Catalogue Adjustments for Comment

On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.

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.

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.

CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE

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.

HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

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.

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION 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.