Feb 9, 2023
Asia
The new article highlights the aspects related to building in the context of applications for marketing approval. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a...
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Feb 9, 2023
Asia
The new article highlights the aspects related to the specific provisions of the current legislation by the device of which the reliance mechanism is implemented into the existing regulatory framework. The article also describes the main principles to be followed when...
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Feb 9, 2023
Asia
The new article addresses the aspects related to possible changes to an existing license, including the transferring local representative, renewal, and manufacturer acquisition. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s agency...
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Feb 8, 2023
EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
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Feb 7, 2023
Asia
The article highlights the key points related to the regulatory requirements for the online importation approval process. Table Of Contents: The National Health Regulatory Authority (NHRA), Bahrain’s regulatory agency in the sphere of healthcare products, has...
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