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On March 11, 2016, the CFDA has released its first issue (nine in total) of national medical device quality announcement, which published the results of quality supervision sample tracking test of 703 batches (sets) of products of 25 types such as metallic bone plates, infant incubators and therapeutic respirators.   The following cases which failed […]

Everyone’s gone to a clinic at some point in time: you get in you register you wait you get in to see the doctor doctor listens to you doctor does diagnostics doctor quizzes you more doctor gives you the prognosis you grab the medication and you’re free to go (after paying) Right?   This is what

The Beijing Municipal Food and Drug Administration released its directive  on GMP certification of medical device manufacturers under its jurisdiction: 156 sterile, implantable medical device manufacturers, 119 IVD reagent manufacturing enterprises, and 111 manufacturers of Class Ⅲ medical devices have met the requirements. According to the “Notice of Beijing Municipal Food and Drug Administration’s Implementation Plan

On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials (CFDA Decree 2016 No, 25). The Regulations will come into effect on June 1, 2016.   1. The formulation background of the Regulations   In 2004, the former SFDA released the Provisions for Medical Device Clinical Trials. However,

On May 27, 2016, the China Food and Drug Administration issued the annual monitoring report of medical device adverse event for 2015, which included an overview of medical device adverse events, statistical analysis, measures for ensuring the safety of medical x-ray angiographic machines, external defibrillators and low-frequency electromagnetic therapy equipment etc. The report comprehensively reflects

“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, published by National Food and Drug Supervision and Administration of Medical Evaluation Centre on May 3, 2016, is now soliciting for public comments until the deadline on May 31, 2016. Following is our analysis of The Draft       Let

The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medical Device Evaluation Consultation” for public comment on May 20, 2016, with comments solicitation period concluding on June 5, 2016. For future product registration – according to these draft guidelines – face-to-face consultation shall be limited to 3 sessions of