Bahrain
The article highlights the key points related to Bahrain’s legal framework for medical device importation.
Bahrain
The new article further describes in detail the regulatory approach to be followed when completing the procedures necessary for the importation of medical devices in line with the regulatory requirements set forth in Bahrain.
Bahrain
The article provides an overview of the approach to be followed in the context of the transition to the new EU-wide regulatory framework for medical devices.
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.
Bahrain
The article highlights the key points related to the regulatory framework for implant cards as set forth under the current legislation.
Bahrain
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
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