Jan 23, 2023
Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
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Oct 20, 2022
Europe
The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
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May 31, 2022
Asia
The new article describes in detail the Essential Principles to be taken into consideration concerning medical devices intended to be marketed and used in Singapore. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
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May 22, 2022
Asia
The article provides an overview of the regulatory framework related to the safety and performance requirements for medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
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May 15, 2022
Asia
The new article highlights additional aspects related to the change notification process, including the turn-around time and fees. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
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