After attending the Medtech Monday event held in Irvine this week, it became very apparent that the thought of managing the regulatory or quality requirements of your product was a scary one for the novice. This had me thinking of key learnings that I’ve found valuable in product development, and thought I’d share a few… […]
TGA’s new recall procedures went live on the 15th of January 2018. The update includes changes to definitions and descriptions –
removing some of the confusing terminology that previously existed. There’s new processes with greater flexibility and clarity – including some new flow charts. We take a look at how to plan for a recall – it happens to everyone sooner or later.
On December 28, CFDA released the draft regulations for inspection of overseas drug and medical device manufacturers. Domestically CFDA has been stepping up inspection efforts for several years, including unannounced and random audits. Now CFDA inspection is going global. We take a look at the proposed inspection program.
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.