News and Updates
FDA 510(k) Clearance: Process, Timeline and Common Pitfalls
Entering the United States healthcare market represents a massive growth opportunity for medical device manufacturers worldwide. However, gaining access to this market requires navigating strict regulatory pathways overseen by the U.S. Food and Drug Administration (FDA). For the vast [...]
COFEPRIS Medical Device Registration in Mexico: A Step-by-Step Guide
Mexico is one of the largest healthcare markets in Latin America. To sell medical devices or in vitro diagnostics (IVDs) in Mexico, foreign manufacturers must secure a Sanitary Registration (Registro Sanitario) from COFEPRIS (Comisión Federal para la Protección contra Riesgos [...]
EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire regulatory strategy under the European Medical Device Regulation (EU) 2017/745 (MDR). Specifically, this classification dictates your compliance pathway in the European Union. Consequently, it impacts clinical data requirements and Notified [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means dealing with a barrage of redundant Quality Management System (QMS) audits. For manufacturers looking to expand globally, this replication of effort consumes valuable time, capital, and resources. The Medical Device [...]
FDA QMSR Explained: What the New Quality System Regulation Means (and How to Prepare)
The wait is over, and the transition window is officially closed. On February 2, 2026, the FDA fully enacted its new Quality Management System Regulation (QMSR). This update completely overhauls the legacy 21 CFR Part 820 (QSR), replacing old, [...]
Swissmedic Announces Medical Device Registration Fees for Swissdamed
Swissmedic has published further details on the registration fees that will apply to medical devices, systems and procedure packs registered in the swissdamed database ahead of the mandatory registration requirements coming into force on 1 July 2026. According to [...]
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise [Malaga, Spain, and Hampton, VA — October 30, 2025] — CMC Medical Devices (CMC), a Spain-based global regulatory consulting firm specializing in medical devices and in vitro diagnostics (IVD), has [...]
New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078? On 17 October 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182 regarding harmonized standards applicable to surgical clothing and drapes, medical face masks, and sterilizers for medical [...]
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices [...]
