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2026 China NMPA Bluebook is here:
On January 11, 2018, the CFDA issued a guideline for accepting medical device international clinical trial data. This new guideline could benefit foreign medical device
According to news reports, on January 9th, during an official business session in front of both the French President Emmanuel Macron and Chinese President Xi
This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the
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