Jan 27, 2023
Malaysia
The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare...
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Dec 1, 2022
Malaysia
The new article describes in detail the aspects related to the roles and responsibilities of the entities engaged in operations with medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices,...
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Jun 21, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published detailed guidance dedicated to all the aspects related to the medical device establishment license (MDEL). Apart from the regulatory procedures to be followed by an...
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Jun 1, 2021
Canada
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects related to the medical device establishment license (MDEL), special permission necessary to carry out the...
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May 17, 2021
Canada
Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In...
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