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?
The annual TGA Sponsor Information day provides a focused full day program on Australian regulatory requirements. here from TGA officials and leading industry experts on how it all works. Still time to register….
With the upcoming Sponsor Information Day being held in Canberra, there will be a great opportunity to network with others from the industry, and most importantly get face to face with our Regulatory Authority. In the past, it was certainly the impression amongst the industry that our agency was not as transparent or as approachable as […]
Last week the US FDA announced a new web page setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals. The fee breaks are substantial (up to 75% off) and a business doesn’t have to be all that small to qualify. Non US businesses can apply too.
Whether you are subject to the regulatory requirements for Medical Devices and need to comply with the Quality System Regulations and ISO13485, or whether you voluntarily implemented an ISO9001 system to generate efficiencies and improve customer experience, implementing a best-in-class Audit program is key to your Quality operations. Is your Audit program up to the task?
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.