Medical Device Regulatory Requirements For China

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Overview of Medical Device Regulation in China

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

These include: (i) extension of registration certificate (which generally is only valid for five years); (ii) device labelling, as may be required under the Administrative Provisions on the Administration of Instructions and Labels of Medical Devices; and (iii) reporting and investigating adverse … See more

NMPA Publishes Revised Chinese Medical Device Regulations

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

NMPA Publishes Revised Chinese Medical Device Regulations. March 29, 2021. China’s National Medical Products Administration (NMPA) has published (links in …

New Regulations on Approval of Medical Devices in China

https://www.roedl.com/insights/newsletter-china/2021-11/new-regulations-medical-devices-china

The Authority may conduct emergency registration for medical devices that are required for public health emergencies and for which there are no comparable products in China or …

China Medical Device Registration - CFDA …

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

Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for …

Regulatory Requirements For Medical …

https://www.syneoshealth.com/insights-hub/regulatory-requirements-medical-devices-china

One of the greatest difficulties for foreign medical device companies in China is its complicated and …

China Medical Device Regulations – An …

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

China Medical Device Regulations – Medical Device Classification. The NMPA classifies medical devices into three categories: Class I, Class II, and Class III. …

An Overview of Medical Device Regulations …

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

Medical device registration in China is now valid for 5 years (previously it was valid for only 4 years). If a manufacturer wants to renew a device’s registration, a …

National Medical Products Administration - NMPA

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

China has 13 COVID vaccines available for second booster A total of 13 types of COVID-19 vaccines, approved for conditional marketing or emergency use, are now available as a …

China Medical Device Registration and …

https://www.emergobyul.com/services/china-medical-device-registration-and-approval

Medical device and IVD registration in China Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and …

China Updates Regulations on Medical Device Registration

https://www.regdesk.co/china-updates-regulations-on-medical-devices-registration/

Requirements for the Application for Medical Device Registration in China The regulation also contains a checklist based on requirements that the application …

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