Your Local Regulatory Representative in Malaysia
Local Authorised Representative (LAR) Services in Malaysia
Entering Malaysia as an overseas medical device manufacturer requires reliable local regulatory representation.
T T Medical provides professional authorised representative services in Malaysia, acting as your local liaison with the Medical Device Authority (MDA) and supporting your regulatory obligations throughout the product lifecycle.
Local Regulatory Representation
Your Authorised Representative in Malaysia
Manufacturers with a principal place of business outside Malaysia require an appointed Authorised Representative to represent them in relation to regulatory responsibilities under the Medical Device Act 2012 (Act 737).
As your independent Local Authorised Representative in Malaysia, T T Medical helps manage regulatory communication, product registration and ongoing compliance while allowing manufacturers greater flexibility in managing their distribution network. We support international medical device and IVD manufacturers seeking to register and market their products in Malaysia.
Our Authorised Representative Services
MDA Regulatory Liaison
Act as your local point of contact for communication and regulatory matters involving the Medical Device Authority.
Medical Device Registration
Support the preparation, submission and management of your medical device registration applications in Malaysia.
Regulatory Compliance Support
Assist with regulatory requirements, documentation, changes and ongoing obligations relating to registered medical devices.
Local Market Coordination
Support coordination between the manufacturer, importer, distributor and other relevant parties involved in the Malaysian market.
A Clear Path to Local Representation
How Our LAR Service Works
01
Regulatory Review
We review your company, medical device portfolio and regulatory requirements for Malaysia.
02
LAR Appointment
T T Medical is formally appointed as your Local Authorised Representative for the applicable medical devices.
03
Registration & MDA Coordination
Our team supports product registration, documentation and communication with the relevant regulatory parties.
04
Ongoing Representation
We continue supporting regulatory matters throughout the lifecycle of your registered medical devices.
Expert Regulatory Guidance
Need Regulatory Support in Malaysia?
Speak with our experienced regulatory team to identify the right registration or representation service for your medical device and receive practical guidance throughout the Malaysian regulatory process.
