Mar 4 - 5:20
The US Food and Drug Administration (FDA), the authority responsible for medical device regulation, issued guidance intended to assist the manufacturers of In Vitro Diagnostic Devices (IVD) in filing applications for...
Mar 3 - 6:16
Health Canada, the Canadian authority responsible for medical device regulation, published a notice announcing the implementation of the electronic Common Technical Document (eCTD) format. The appropriate pilot project...
Mar 2 - 4:10
The US Food and Drug Administration (FDA), the authority responsible for medical device regulations, issued guidance dedicated to recommendations for Dual 510(k) and CLIA Waivers by application pathway. CLIA Waiver:...
Feb 28 - 4:58
The Saudi Food & Drug Authority, the agency responsible for medical device regulation in the Kingdom of Saudi Arabia, issued draft guidance dedicated to the classification of the combination products. The document...
Feb 27 - 6:08
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical...
