December 9, 2019 – Global Regulatory Update

Saudi Arabia Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has rolled out a single registration platform for all medical device market authorization, authorized representation, and related applications to be submitted to the regulator. The new system,  Ghad, provides a single platform for submitting Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi […]

Post-Market Surveillance

Medical device post-market surveillance (PMS) activities are described in the European Medical Device Directive (93/42/EEC) and are part of the Quality Management System (QMS) certification under EN ISO 13485:2016. However, resulting from various concerns surrounding PIP implants, PMS activities and oversight powers of Notified Bodies (NB) and Competent Authorities (CA) have been reinforced. Therefore, consequently, […]

FDA Guidance​ Documents

The US FDA has produced the A-List of Guidance Documents that CDRH intends to publish in FY2020.  A-List: Prioritized Guidance Documents for FY2020  Final Guidance Topics Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Recommendations for Dual 510(k) and Clinical Laboratory Improvement […]

U.S. FDA Medical Device Update

Everyone, This is a very important regulatory update: U.S. FDA Medical Device Update US Food and Drug Administration medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications will increase by about six percent for the agency’s 2020 fiscal year. FDA’s 2020 user fee schedule takes effect October 1, 2019, and entails six-percent […]