Expanding into Southeast Asia sounds like the natural next step for many medical device companies. The demand is growing, the market is attractive, and opportunities seem everywhere. Until you start dealing with regulations. Each country has its own requirements, processes, and timelines. While ASEAN has introduced some level of alignment, the reality is still far …
Malaysia Medical Device Regulations vs Singapore & ASEAN 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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