Feb 9, 2023
Asia
The new article highlights the aspects related to the conditions to be fulfilled for a reliance mechanism to be applied and also describes its key components. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the...
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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 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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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
Canada
The new article highlights the aspects related to situations when clinical data is not needed, as well as to the changes to medical devices and amendments to the respective applications. Table of Contents Health Canada, a country’s regulating authority in the sphere...
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