Chinese Medical Device Regulations

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. …

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 …

China Medical Device Regulations – An Overview

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

China Medical Device Regulations – Medical Device Classification. The NMPA classifies medical devices into three …

Overview of Medical Device Regulation in China

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

China Introduces New Medical Device Regulations - FDAnews

https://www.fdanews.com/articles/202160-china-introduces-new-medical-device-regulations

The Chinese State Council has approved new medical device regulations that will go into effect on June 1, 2021. Under the new regulations, conditional approvals …

National Medical Products Administration - NMPA

https://english.nmpa.gov.cn/

The Chinese mainland on Sunday reported 55 new locally transmitted COVID-19 cases, the National Health Commission said in its daily report on Aug 2. ... Laws & Regulations. ...

Revised Chinese Medical Device Regulations by …

https://www.makrocare.com/blog/revised-chinese-medical-device-regulations-by-nmpa/

On 18Mar2021, from NMPA published the final version of “Regulations on the Supervision and Administration of Medical Devices” (i.e., State Council Order #739) and will come into force on June 1, 2021. …

An Overview of Medical Device Regulations in China

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 (previously it was valid for only 4 years). If a …

NMPA (CFDA) Regulations - China Med Device

https://chinameddevice.com/resources3/nmpa-cfda-regulations-3/

MJPRC-2018-08-25-1. Amended Regulation on Supervision and Management of Medical Devices (Draft) Draft. Ministry of Justice. June 25, 2018. Download. Decree No.7 CFDA, …

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 registered as a Class 2 product in the US or …