China Proposes Simpler Medical-Device Re-Registration Rules

New Regulations on Approval of Medical Devices in China

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

New Regulations on Approval of Medical Devices in China. On 31 August 2021, the State Administration for Market Supervision and Administration adopted the Administrative …

China Amends Regulation Governing Medical Devices

https://www.morganlewis.com/pubs/2021/04/china-amends-regulation-governing-medical-devices

Changs to Chinese Medial Device Regulation - The …

https://www.natlawreview.com/article/five-things-to-know-about-changes-to-china-s-medical-device-regulation

The 2021 Amendment contains an exemption for certain innovative foreign-manufactured medical devices to be registered with the National Medical Products …

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

The 2021 Amendment streamlined several aspects of the medical device registration process, such as: (a) an applicant of Class II and Class III medical devices …

China Unveils New Medical Device Regulations - Ropes …

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

Historically, foreign device manufacturers were required to appoint a Chinese legal entity as their local legal agents (also known as local legal deputies) in order to fulfill …

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 will …

China Updates Regulations on Medical Device Registration

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

Chinese Requirements for the Medical Device Submissions Review. The CMDE states that initial requirements for submission filed in the course of applying for the …

China Proposes Simpler Medical-Device Re-Registration Rules

https://dayofdifference.org.au/c-medical/china-proposes-simpler-medical-device-re-registration-rules.html

Recently, China Food and Drug administration (CFDA) published a draft for comment on pathways to simplify and speed up the medical device re-registration process. With the …

China streamlines re-registration of medical devices

https://brandwoodckc.com/china-streamlines-re-registration-of-medical-devices/

Re-scheduling / Re-classification Services; Postmarket Compliance & Surveillance; Regulatory and Administrative Appeals; Literature-Based Medicine …