Feb 1, 2024
EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
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Mar 23, 2023
Asia
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
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Mar 6, 2023
Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
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Feb 17, 2023
Asia
The new article covers the aspects related to the application of the reliance approach to specific categories of healthcare products and also provides an overview of the reliance procedures. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...
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Feb 17, 2023
Asia
The new article highlights the aspects related to the application of the reliance approach in the context of marketing authorization for medical devices. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of...
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