T T Medical Management Sdn Bhd (T T Medical), the earliest company in Malaysia providing Local Authorized Representative services (LAR) and Product Registration advisory services to manufacturers worldwide.
We have been active in providing Medical Device Management System and Medical Device Regulations related training and consultancy services for the past 20 years. We specialize in guiding clients to comply with international medical regulations such as CE Mark, US FDA, TGA, JPAL and CMDCAS.
Our existence in the industry has given us the advantage to work closely with the Conformance Assessment Body and the Authority (i.e Malaysia Medical Device Authority). We receive first-hand information on all the latest development of the Medical Device Regulations in Malaysia.
We can provide a comprehensive support to our clients from developing Medical Device Management System until completion of the product registration process with the Authority.
In addition, T T Medical also provides a range of other consultancy support services including Training and Audit services.
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.
