Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual benefits and challenges this Pathway brings. In this article, I try to make it a little clearer on what leads to a successful application and […]
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.
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.
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.
CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?