Swissmedic
The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.
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.
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...
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
