Feb 7, 2023
Asia
The article covers the general points related to the regulatory requirements for combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for...
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Feb 2, 2023
Malaysia
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
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Nov 9, 2020
Asia
The Medical Device Authority (MDA), the department of the Ministry of Health Malaysia responsible for medical device regulations, has published guidance dedicated to the registration of conformity assessment bodies (CABs). The document consists of two parts: general...
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Sep 15, 2020
Asia
The Food and Drug Administration (FDA) has published a safety communication dedicated to the use of the cold-therapy mode of water-circulating hot/cold therapy devices. The document is intended to remind the users of the aforementioned devices about the importance of...
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Sep 14, 2020
Asia
The Medical Device Authority (MDA) of Malaysia has published a guidance document dedicated to the requirements for registration of conformity assessment bodies (CABs). In particular, the document describes the requirements the entity shall meet in order to be eligible...
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