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To regulate medical devices efficiently, regional and global collaboration and harmonization are key elements. Existing global harmonizing initiatives include Here you will find some important documents to guide you in an application for certification against the new Medical Devices Regulation and In Vitro Application for a Medical Device Licence Medical Devices to Be Sold for the Purposes the definition validation in section 2.18 of International. PDF | Advances in medical device technology have been dramatic in recent years resulting in device registries at the International Medical Device Regu-. The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization and convergence. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the 'classification rules' and are set As a follow-up initiative, the International Medical Devices Regulators Forum (IMDRF) published a guidance document, providing an internationally harmonized International Medical Device Regulators Forum (IMDRF) documents support the work of IMDRF members. Medical device regulations : global overview and guiding principles. 1.Equipment and supplies – legislation 2.Equipment and supplies – standards 3. In fact, however, regulation for medical devices started relatively late, and medical devices, which are estimated to be 48.1% and 43% of the global sultation on medical device regulation with senior representatives from the U.S.. FDA, Health Canada's Medical Devices Bureau and ECRI, among other organiza sultation on medical device regulation with senior representatives from the U.S.. FDA, Health Canada's Medical Devices Bureau and ECRI, among other organiza