FDA
The article highlights the key points related to the regulatory framework for remanufacturing medical devices, outlining the main considerations and critical aspects.
Swissmedic
The new article elaborates on the specifics of the regulatory approach medical device software products are subject to.
HPRA
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
Malaysia
The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use in Malaysia.
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.
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