The Malaysia Medical Device Regulations 2012 requires a manufacturer located outside of Malaysia to designate a Local Authorized Representative as a liaison to the Malaysia Authorities.
T T Medical provides qualified and professional Authorized Representative Services in Malaysia and will support your regulatory compliance.
By appointing us as your independent representative, you will keep the highest possible flexibility in your distribution network. Our services will facilitate the fast entrance of your device into the Malaysian market.
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. For more details of the MDA , please visit Medical Device Authority (MDA) Malaysia.
