Jun 23, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the current classification of in vitro diagnostic medical devices (IVDDs). The document provides an...
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Jun 4, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for healthcare products, has published a guidance document describing transitional rules on reclassification of active implantable medical devices (AIMD). The regulatory...
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May 26, 2021
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
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Apr 27, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a final rule on medical device classification. The appropriate notice of the amendment to the medical device classification regulations...
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Mar 14, 2021
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), a department of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan, a country’s regulating authority in the sphere of medical devices,...
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