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.
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 […]
On October 3, the TGA announced a revision to the URPTG, which is accompanied by a 3 month “familiarisation period” before taking effect on 15th January 2018. We take a look at the new expectations TGA has of manufacturers and sponsors. What would you do – are you prepared for a recall?
China’s CFDA released draft regulation changes in October with far reaching proposals including faster Clinical trial approvals and abolition of Type Testing. At the same time CFDA is getting tougher in postmarket supervision. This could all be law by Chinese new Year.