Sep 23, 2022
Malaysia
The article describes updated guidance on re-registration and highlights the key aspects to be taken into consideration for the procedure. The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a second...
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Sep 11, 2022
Malaysia
The article describes in detail the approach to be applied when determining the regulatory nature of borderline products as set forth by the current legislation in Malaysia. The Medical Device Authority (MDA), a body of the Ministry of Health Malaysia responsible for...
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Apr 26, 2021
Malaysia
The Medical Device Authority (MDA), the Malaysian authority responsible for medical device regulations, has published updated guidance on advertising rules for medical devices intended to be marketed on the domestic market. The document is intended to assist medical...
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