China Medical Device Regulation

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 & International Drug Regulatory Authorities Dialogue" was held online. Mr Xu Jinghe, Deputy …

Overview of Medical Device Regulation in China - Morgan Lewis

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

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 …

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 …

China Medical Device Regulations – An Overview

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

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for …

Rules for Classification of Medical Devices - NMPA

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

Decree No.15 of China Food and Drug Administration The Rules for Classification of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 3, 2015, is …

China Order 739: New Medical Device and New IVD …

https://www.cisema.com/en/order-739-new-medical-device-and-new-ivd-regulation-effective-from-october-2021/

Order 739: New Medical Device and New IVD Measures Effective From October 2021 On August 26, 2021, the SAMR (State Administration for Market …

An Overview of Medical Device Regulations in China

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 institution responsible for …

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 …

China medical device registration review requirements - Sept 2022

https://www.cisema.com/en/china-medical-device-registration-review-requirements-sept-2022/

The Center for Medical Device Evaluation (CMDE) of the NMPA will review the application materials of the corresponding application in accordance with the revised …