Feb 7, 2023
Asia
The article describes the general principles outlined in the respective policy adopted by the authority and explains the approach the authority intends to apply. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of...
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Feb 2, 2023
Asia
The new article highlights the aspects related to changes to existing licenses and also addresses some other matters, such as the registration rules applicable to specific types of medical devices. Table Of Contents The National Health Regulatory Authority (NHRA),...
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Feb 2, 2023
Asia
The article provides an overview of the new draft guidance and highlights the key points to be considered. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s agency responsible for healthcare products regulations, has published a guidance...
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Jan 27, 2023
Canada
The new article highlights the key points related to comparator devices in the context of submitting clinical evidence when applying for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has...
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Jan 16, 2023
EU MDR/IVDR
The new article highlights the aspects related to non-conformity which does not impose unacceptable risks to health and safety. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...
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