22 Class II Device Guidelines Ask for Feedback
April 16, 2021
NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedbacks need to be submitted by April 17, 2021. It is responding to the “2021 Medical
NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedbacks need to be submitted by April 17, 2021. It is responding to the “2021 Medical
NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30. If these standards are applicable to your device, please check your product’s design file and your
In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian,
NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China.
The NMPA (CFDA) Newsletter covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a
NMPA (CFDA) announced revisions of 27 medical device technical standards on June 6, 2019, involving multiple devices including Co-60 Teletherapy Unit, Infusion Sets with Precision Filters for Single Use and
Primarily due to the pressing problem of doctor shortage, the Chinese government is eagerly encouraging medical use of Artificial Intelligence. Currently, China has two kinds of license for AI medical
NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical
On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication.
In order to guide the applicant to make proper application, NMPA(CFDA) has published the summary of the attribute definition results of drug-device combination products starting from 2009 to the present.
Monthly CFDA News Roundup covers government announcement, 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),
Monthly CFDA News Roundup (August) Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by
USA Office
800 Turnpike St. Ste 300
North Andover, MA, 01845
China Office
Room 1501, Floor 12, No. 24 A
Jianguomenwai Avenue
Chaoyang District, Beijing, China