Blogs

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 […]