Health Canada Launches Phase II Consultation to Modernize Medical Device Establishment Licences (MDEL)
Translated with AI On November 8, 2025, Health Canada (HC) launched a public consultation on the proposed modernization of the Medical [...]
Translated with AI On November 8, 2025, Health Canada (HC) launched a public consultation on the proposed modernization of the Medical [...]
Translated with AI On October 23, 2025, the Spanish Royal Decree No. 942/2025 was published in the Boletín Oficial del [...]
Translated with AI Interesting incentives continue for medical device manufacturers interested in expanding into the Asian market. In September 2025, [...]
Translated with AI In September 2025, the Borderline and Classification Working Group (BCWG), an advisory group established by the European [...]
Translated with AI On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published new guidelines and a [...]
Translated with AI Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation processes [...]
Translated with AI Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection against [...]
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for manufacturers." [...]
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, [...]
Translated with AI The Team-NB, the European association of Notified Bodies for Medical Devices, published the second version of its Position [...]