Chinese Registration Medical Devices

NMPA Publishes Revised Chinese Medical Device Regulations

https://www.emergobyul.com/news/nmpa-publishes-revised-chinese-medical-device-regulations

March 29, 2021. China’s National Medical Products Administration (NMPA) has published (links in Chinese) the revised Regulations on the Supervision and Administration of Medical Devices, which introduces changes to the existing Order No. …

China Medical Device Registration - CFDA Approval

https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/china/

The first step in registering your medical device in China is to classify your product in China. China classifications range from Classes 1-3. However, just because your product is …

Overview of Medical Device Regulation in China

https://www.morganlewis.com/pubs/2020/02/overview-of-medical-device-regulation-in-china

China NMPA Regulatory Approval Process for Medical Devices

https://www.emergobyul.com/resources/china-nmpa-regulatory-approval-process-medical-devices

Determine classification of your medical device in China using the National …

National Medical Products Administration - NMPA

http://english.nmpa.gov.cn/

Regulatory Information. Announcement of the Center for Food and Drug Inspection of NMPA on Issuing 5 Documents including the Work Procedures for Drug Registration Inspection …

Medical Device Registration in China - Asia Actual

https://asiaactual.com/china/medical-device-registration/

Products must have home country approval prior to applying for registration in China. Medical device registration in China is now valid for 5 years (previously it was valid for …

China Medical Device Regulations – An …

https://chinameddevice.com/medical-device-regulations-in-china/

Medical Device Registration. All medical devices must be registered with the NMPA. Furthermore, overseas device manufacturers should follow a specific …

An Overview of Medical Device Regulations …

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-china/

All product information on packaging and labeling must be translated to Simplified Chinese. Medical device registration in China is now valid for 5 years …

China - Medical Devices | export.gov

https://legacy.export.gov/article?id=China-Medical-Devices

The medical device market is one of the fastest growing market sectors in China, with the industry maintaining double-digit growth for over a decade. In 2018, the medical device …

Certification of Medical Devices in China

https://incompliancemag.com/article/certification-of-medical-devices-in-china/

The CFDA frequently publishes new regulations and standards for the certification and registration of drugs and medical devices for China’s …