If you’re planning to register a medical device in Malaysia, one of the first things you’ll need to figure out is your device classification. It might sound like a small step, but it actually shapes everything from the documents you prepare to how long approval takes with the Medical Device Authority (MDA). We’ve seen many …
Examples of Class A, B, C & D Medical Devices in Malaysia Read More »
T T Medical Management Sdn Bhd is an established Authorised Representative (“AR”) company. We are licensed by the Medical Device Authority (“MDA”) which regulates medical devices under the “Medical Device Act 2012” and “Medical Device Regulations 2012”. Under the regulation, all foreign manufacturers must appoint an AR to submit the registration application of their medical devices.
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