Registration

March 11, 2019

ChinaMed Device is cited by BioWorld MedTech

On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices. With revised registration guidelines, China moves closer […]
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 […]
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 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 […]
August 29, 2018

CFDA: 99 Device Standards to be Revised in 2018 – Huge Impact on Renewals and New Registrations

CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is the finalized version of the […]