Medical Device Regulations 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

This article outlines the regulatory framework and pathways, the classification of devices, and post-market compliance matters, as well as the specific provisions governing customized medical devices. Activities related to medical devices in the People’s Republic of China (PRC) [1], including their manufacturing, mar… See more

National Medical Products Administration - NMPA

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

On the evening of December 20, 2022, the "China International Medical Device Regulatory Forum (CIMDR) - Global Harmonization Working Party (GHWP) Session …

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 …

Rules for Classification of Medical …

http://english.nmpa.gov.cn/2019-10/11/c_415411.htm

The Rules for Classification of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 3, 2015, is hereby promulgated and shall be effective as of …

China Medical Device Regulations – An Overview

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

China Unveils New Medical Device Regulations - Ropes …

https://www.ropesgray.com/en/newsroom/alerts/2021/March/China-Unveils-New-Medical-Device-Regulations

The Chinese State Council has passed new Medical Device Regulations (State Council Order #739) to replace the existing Medical Device Regulations (State …

An Overview of Medical Device …

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

An Overview of Medical Device Regulations in China. The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the …

Five Things to Know About the Changes to China's …

https://www.klgates.com/Five-Things-to-Know-About-the-Changes-to-Chinas-Medical-Device-Regulation-7-21-2021

On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and …

China CFDA Medical Device

https://www.pacificbridgemedical.com/regulation/china-medical-device-pharmaceutical-regulations/

China Medical Device & IVD Regulatory Webcast. The comprehensive China Medical Device & IVD Regulatory Webcast provides in-depth information on China’s medical device and IVD …

China - Regulatory Market Profile

https://www.rimsys.io/regulatory-market-profiles/china

One of the major changes included in Order 739, China’s medical device regulation effective June 1, 2021, was a new emphasis on the entire life cycle of a device. Order 739 …

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