The Chinese Food and Drug Administration (CFDA) has announced a 5-month campaign targeting 5 key areas of foul play in the medical device industry. The scope comprehensively covers the pre- and post-market activities, involving manufacturers, distributors as well as clinics.
Archives for March 2014
On February 14, 2014 the US Food and Drug Administration (FDA) published its final rule on 21 CFR Part 803 Medical Device Reporting: Electronic Submission Requirements. Effective August 14, 2015 manufacturers and importers of Medical Devices into the United States will be required to submit all adverse event reports through the eMDR. While electronic reporting provides a more efficient process there are traps.
As part of the strengthening of market surveillance activities in China, the China Food and Drug Administration (CFDA) has exposed 10 websites containing false online advertising for medical devices.
Manufacturer with patented/patentable medical devices now have the opportunity to fast track their device registration and clinical trial in China thanks to the “Special Review and Approval Procedure for Innovative Medical Devices”, effective March 2014.
“Our Chinese application for a Class III medical device had been stalled and was in danger of rejection by CFDA. Brandwood Biomedical were able to resolve the impasse and to take us forward to approval. We were delighted with their ability to understand our product, communicate effectively with CFDA at the right level and achieve a positive and timely outcome.”
European manufacturer of advanced wound care products
“I very much enjoyed the round table discussions, with Arthur’s great depth and breadth in medical device regulatory matters, across the types of devices and different regions and countries. I continued to be amazed by Arthur’s ability to have very interesting and insightful comments on almost every subjects brought out by different people around the table, especially the last remark on reversed engineering challenges in China…”
Seminar participant – Singapore