Mar 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document...
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Mar 19, 2021
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
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Mar 19, 2021
EU MDR/IVDR
The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
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Mar 19, 2021
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published the updated rules for evaluation of the software intended to be used for medical purposes. The document initially issued on February 12, 2021, and named “The...
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Mar 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published the updated guidelines on the risk management approach to be applied with regard to medicines and medical devices. The document provides...
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