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The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices.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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Jul 23, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device license applications. In particular, the document describes how medical devices could be combined when...
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Jul 19, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to medical device license applications for ultrasound diagnostic systems and transducers. The document...
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Jul 14, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to completing the application for a new medical device license or medical device license amendment for a private label medical device....
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