EU Cosmetics Regulation 2024: New Ingredient Restrictions
On April 3, 2024, the European Commission adopted Regulation (EU) 2024/996, bringing further amendments to the Cosmetics Regulation (No. 1223/2009).
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US Medical Device Market Entry: Key Strategies and Burdens
Responsible for approximately 50% of the estimated USD 578.75 billion global medical device market (in 2024), North America continues…
Key Global Markets for US Medical Device Manufacturers
For US medical device manufacturers considering non-US markets, understanding the influence of North America’s dominant medical device landscape and…
New Modifications on Vigilance Terms from MDCG
MDCG has made minor modifications to the MDCG 2023-3 guidance, “Questions and Answers on vigilance terms and concepts…
FDA Draft Guidance on AI-Enabled Device Submissions
The FDA has issued their draft recommendations (January 2025), regarding the content of marketing submissions for medical devices that…
Medical Device Registration in Mexico with COFEPRIS
Navigating medical device registration in Mexico with the Federal Commission for Protection against Health Risks (COFEPRIS) can be challenging for…
eSTAR Guidelines for Successful FDA Submissions
All medical devices seeking to market into the US may require multiple submissions of various types to the Food and…
New Post-Market Surveillance Rules for UK Medical Devices
The publication of Statutory Instruments 2024 No. 1368 introduces significant amendments to the Medical Device Regulations in Great Britain. These…
TGA Consultation: Medical Device Audit Framework
The Therapeutic Goods Administration (TGA) has announced a public consultation on two draft guidance documents as part of its new…
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