Feb 7, 2023
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
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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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Oct 7, 2019
Indonesia
The MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, as well as support registrants in determining medical device risk classes. Indonesia’s Device Risk Classification...
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Mar 26, 2019
Australia and Oceania
The Australian medical device regulation authority, the Therapeutic Goods Administration (TGA), published proposed changes in March of 2019 that will affect the current classification system of medical devices. The main goal of the proposed changes is to harmonize the...
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Jan 8, 2019
North America
The institution responsible for regulating medical devices in Canada is the Medical Devices Bureau (MDB) of the Therapeutic Products Directorate (TPD), a federal authority within Health Canada. TPD uses a Canadian Risk-Based Classification System (RBCS) to classify...
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