Tag: Medical Device Authority (MDA)

post-image
29 October 2025
Malaysia

No Automatic Market Entry For US Medical Devices: MDA

On the Malaysia-US reciprocal trade deal, MDA says acceptance of US FDA approvals doesn't mean "automatic market entry" for medical devices made in America. All medical devices must still be registered with MDA to ensure compliance with local regulations.
post-image
10 June 2025
Malaysia

Cannabis Vaporisers Are Not Medical Devices, Says MDA

The Medical Device Authority says cannabis vaporisers are not considered a "medical device", either in Malaysia or globally. Ispire Malaysia isn't registered with MDA. An establishment licence is needed to manufacture medical devices, including for export.