Blog

March 5, 2019

Common Issues in NMPA Clinical Trial Audit (2016-2018)

NMPA (CFDA) clinical trial requirements have been significantly strengthened over the years. In 2016, 8 out of 20 clinical trials have been identified with issues in clinical trial audits. In […]
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 […]
February 15, 2019

CFDA Monthly Roundup (January)

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 […]
February 10, 2019

Overseas Inspection Results in Jan: Big Players Cited

NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including some big players, BD, Boston […]
February 8, 2019

ChinaMed Device Cited by RAPS on Overseas Inspection

On January 18, 2019, NMPA (CFDA) announced the first batch of Overseas Inspection Results in 2019. Five foreign manufacturers, including BD and Rayner, were cited with 24 observations. Grace Palma, CEO of […]
February 6, 2019

CRO Success for World’s First CT-LINAC by ChinaMed Device, LLC

NORTH ANDOVER, Mass. – January 31, 2019 – ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped United Imaging […]
January 31, 2019

Want to Meet with CFDA Reviewers Face to Face with Questions?

Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to double check your registration questions […]
January 29, 2019

Intellectual Property: CFDA Asks Feedback for Medical Device Master Files Filling Process

On January 3, 2019, NMPA (CFDA) issued Medical Device Master Files Filing Process (draft) for feedback. Feedbacks need to be submitted by Feb 4, 2019. Medical device master file in […]
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

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

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. […]