In vitro diagnosis

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 […]
November 6, 2018

CFDA Monthly Roundup (October)

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 (, […]
October 26, 2018

NMPA (CFDA) Monthly Roundup (September)

May 24, 2018

Immuno-Diagnostics: Continuous Growth Market in China

According to the statistics of China Blueprint for In Vitro Diagnostic, as of 2016, the size of China’s immunodiagnostic market reached 16.2 billion RMB (2.61 billion USD), accounting for 33% […]
May 24, 2018

Aging Population is Boosting China IVD Market

Due to the impact of the birth control policy and the decline in birth rate after the economy growth, the population structure in China is gradually entering an aging society. […]