So you got your registration. It was hard, but you got there. All that pesky regulatory stuff is done and now you can get on with the real business of selling product. But, of course, it’s not the end of the story. Regulation is whole-of-product-life and postmarket monitoring matters. No more so than in China, where the latest changes in CFDA regulations mean renewals are now all about looking back at the postmarket record. If you haven’t paid attention to postmarket, expect to struggle with registration renewal. We take a look at the latest changes in China and how to be prepared.
Archives for December 2017
Australia’s Therapeutic Good Advertising Code is due for a revamp. Current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. But current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. We look at the announced and proposed changes and what this all means for consumers and the industry.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
As the festive season quickly approaches, we find that some of the most important things are put on hold. However, now is actually the best time to ensure all your regulatory requirements are being met to allow for a clear and hassle-free holiday period! Devices included on the Australian Register of Therapeutic Goods (ARTG) carry […]