regulation

February 25, 2019

2019 Registration Guidelines Revision Plan Announced Today: Huge Impact on Registrations and Renewals

NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” today (February 25), in which 86 medical devices, IVDs and documentation methods are included. The Guidelines Revisions are aimed to […]
October 24, 2018

AstraZeneca and 5 Others Caught for Violating China’s Human Genetic Regulation: Clinical Data Rejected

The Ministry of Science and Technology of China imposed penalties today (Oct 24th) on 6 companies for violating regulations on human genetic resources. AstraZeneca and 5 domestic companies are on […]
June 23, 2018

Weekly CFDA News Roundup (June 11th to June 18th) 

Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]
June 13, 2018

Weekly CFDA News Roundup (June 3rd to June 10th)

Weekly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]
June 11, 2018

Monthly CFDA News Roundup (May 2018)

Monthly CFDA News Roundup covers policies, government reports, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]
May 29, 2018

Weekly CFDA News Roundup (May 20th to May 26th)

Weekly CFDA News Roundup covers government reports, policies, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) a […]
May 23, 2018

Weekly CFDA News Roundup (May 13th to May 19th)

Weekly CFDA News Roundup covers policies, industry standards, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting […]
May 15, 2018

Weekly CFDA News Roundup (May 6th to May 12th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
May 9, 2018

Monthly CFDA News Roundup (April)

Monthly CFDA News Roundup covers policies, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
April 24, 2018

Weekly CFDA News Roundup (April 14th to April 21st)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
May 25, 2017

Chinese Premier Signed a State Council Order for the Modification of China Medical Device Regulation Policy

China’s Premier Li Keqiang just signed the State Council Order No. 680, announcing the Decision on Modification of “Medical Device Regulation Policy” by the State Council, effective immediately. The State […]
November 10, 2016

Life Sustaining Ventilators Clinical Evaluation Guidelines for Feedback Draft

If you need to provide feedback to CFDA, please let us know and we will consolidate and send it for you.  Please email to . If you want to email […]