Global Regulatory Updates #6: UK, Montenegro, and Mexico from May 2, 2024

This week's top three global regulatory updates include:
1. United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) has revised its contact information and updated links to guidance, including the latest version (9.0) of its clinical investigations guidance for manufacturers.
2. Montenegro: The Institute for Medicines and Medical Devices is implementing new rules for in vitro diagnostic medical devices, based on EU Regulation 2017/746. These rules apply to devices marketed after May 26, 2022, with a grace period for those previously approved under Directive 98/79/EC, depending on their risk class.
3. Mexico: The Mexican government has published a draft of the Official Mexican Standard 262 SSA1 2024 on good clinical practices. This standard outlines the criteria for institutions conducting research on human subjects. Interested parties can submit comments in Spanish within 60 days of publication in the Official Journal of the Federation.
Stay tuned for more updates!