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UDI and Changes to UDI’s: MDCG Guidance
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI)...
Document Submissions in Mexico: Guidelines
All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of...
Overview: FDA NESTcc Methods Framework
The National Evaluation System for Health Technology Coordinating Center (NESTcc), an organization created and supported by the US Food and Drug Administration (FDA) that focuses on the development of new approaches to...
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:...