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.
Medical Device Regulation Resources
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is...
United States
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on the latest standards helps businesses avoid costly violations and improve the efficacy and safety of...
Australia
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
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