Regulatory Requirements For Medical Devices In 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 …

NMPA Publishes Revised Chinese Medical Device Regulations

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

China’s National Medical Products Administration (NMPA) has published (links in Chinese) the revised Regulations on the Supervision and Administration of …

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 Regulations – An …

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

China Medical Device Regulations – Medical Device Classification The NMPA classifies …

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 Registration - CFDA …

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

The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and …

An Overview of Medical Device Regulations …

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

An Overview of Medical Device Regulations in China. Jan 9, 2019. The National Medical Products Administration (NMPA), previously the China Food and …

China NMPA Regulatory Approval Process …

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

Common ways to satisfy this requirement include: ISO 13485 certificate; Establishment Registration from the FDA for US companies; or Manufacturing License for Japanese or …

National Medical Products Administration - NMPA

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

Mr Xu Jinghe Attends the “CIMDR - GHWP Session & International Drug Regulatory Authorities Dialogue”. On the evening of December 20, 2022, the "China International …

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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