medicines-medical devices-regulatory affairs
Last updated: 23 May 2024 Updates are listed at the end of the post. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations. EU MDR amendment of 20 March 2023 Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional…
Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs). Why is Health Canada consulting on this policy? Health Canada is updating its policy on DDCPs to provide more detail and clarity…