CFDA Updates

January 25, 2019

CFDA: 12 IVD Standards to be Updated in 2019 – Huge Impact on Renewals and New Registrations

NMPA (CFDA) announced “2019 Medical Device Industry Standard Revision Draft Plan” for public comments on December 11, 2018 to medical device/ IVD regulations in order to be more consistent with […]
January 17, 2019

CFDA Monthly Roundup (December)

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 ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
January 11, 2019

NMPA (CFDA) Must Read: Acceptance of Overseas Clinical Data

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 […]
January 4, 2019

NMPA (CFDA) Must Read—— New Guideline for Overseas Inspection

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. […]
December 18, 2018

What are the NMPA(CFDA) interpretation of the combination products attributes?

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. […]