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MDCG Guidance on Significant Changes
The Medical Devices Coordination Group (MDCG), an advisory body of the European Commission, issued a guidance document dedicated to the significant changes to medical devices subject to regulation under the Medical...
FDA Policy on Diagnostics Testing for COVID-19
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance for clinical laboratories dedicated to Coronavirus Disease-2019 during the public health emergency....
FDA Guidance on Third Party Review Program
The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review...
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...