MDCG
The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
Bahrain
The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the transition from Medical Directives to Regulations – the new regulatory framework recently adopted in the European Union.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in operations with medical devices in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Australia
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
Australia
The new article describes in detail the first three steps of a recall process, which include obtaining information and distribution status, conducting a risk analysis, and deciding on the type, class, and level of recall.
FDA
The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
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