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FDA Guidance on CLIA Waiver Applications for IVDs
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...
Health Canada Implements eCTD for Clinical Trials
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...
FDA Guidance on Dual 510(k) and CLIA Waivers
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:...
TGA Timeframes for Regulation of Medical Devices
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...