Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
On December 26th, 2017, the ‘Notice on Enforcing the Three-year Action Plan for Strengthening Core Competitiveness in Manufacturing Industry (2018-2020) and Implementation Plan for Industrialization
As part of an effort to standardize the overseas inspection of drug and medical device manufacturing and ensure the quality of imported products, the CFDA just
What is Big Health? Big health includes health service, pharmaceuticals, medical device, wearable health device, physical therapy, beauty, dietary supplements, healthy diet, sports and recreation,
CFDA approves first four 3D printed human body implants In September 2015, the first 3D printed human body implant – the artificial hip joint was
Recently, in order to speed up the development of advanced manufacturing industries, promote the deep integration of the Internet, big data, artificial intelligence and real
As planned, CFDA is to enforce its “Medical Devices Online Sales Supervision and Management Measures” on March 1st, 2018 that governs online sales of all
1. Scope This guideline applies to the application registration of class II and III mobile medical devices. 2. Mobile Medical Device (1) Definition of Mobile
As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA
Learn Key CFDA Premarket Submission Tips for IVD Approval Registration is closed for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST
China’s Grand Pharmaceutical has announced that it entered into a subscription agreement with Canada’s Conavi Medical. The two companies also entered an exclusive distribution agreement
The CFDA issued 12 new guidelines on December 22nd, 2017. While they are titled guidelines, once they are officially released, you are expected to comply with
CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual