Asia’s big – really big, and for those of you in the US it’s a long way from home. So on March 5-6, we are assembling some of the top RA experts practising in Asia for a two day Asia Pacific Device Summit in warm and sunny San Diego, California. Come and join us in […]
Archives for January 2015
Each January FDA publishes a list of guidances proposed for publication in the coming year. The list is divided into “A” and “B” lists. And just like in Hollywood – look to the A-list to see who’s in fashion and where the happening trends lie. So what’s hot for 2015?
The introduction of Medical Device User fees in China has been anticipated since the introduction of new Medical Device regulation mid-2014. However, the amount proposed in the draft for comment fee table may raise a few eye brows. This level of CFDA fees will likely impact the current arrangements where distributors provide “Free” registrations for their suppliers as incentive – seeing there’s now real money at stake in getting a registration approved, even before the commercial ramifications of slow or failed submissions.
The Indian Centre for Drug Safety and Control announced on 31 December 2014 a Bill to to introduce the most comprehensive reform of drug and device regulation in India in decades. Borrowing from US FDA and GHTF/European models, the Bill introduces new oversight for clinical trials, a comprehensive set of medical devices regulation and explicitly brings advanced biologics such as stem cells, gene therapies and xenografts under regulatory control.
China FDA announced on 29 December the anticipated Good Manufacturing Practice for Medical Devices. The Code is effective 1 March 2015. Click through to Download an English Translation.