Do you want to sell your medical device in Malaysia but don’t have a local office? You’ll need an Authorised Representative (AR) in Malaysia. This is required by law and helps you register your device quickly, follow all rules, and stay compliant with the Malaysian government.
What is an Authorised Representative (AR) in Malaysia?
The Medical Device Authority (MDA) in Malaysia says that foreign companies must appoint a local company as their Authorised Representative. This is part of the Medical Device Act 2012 (Act 737).
The Authorised Representative acts as a legal liaison between the foreign manufacturer and the Medical Device Authority and is responsible for:
- Registering medical devices through MeDC@St (Medical Device Centralized Online Application System).
- Ensuring compliance with Good Distribution Practice for Medical Devices (GDPMD)
- Facilitating Post Market Surveillance activities and adverse event reporting
- Maintaining regulatory documentation and handling inspections
Why You Need an AR if You Don’t Have a Malaysian Office
Selling medical devices in Malaysia without local help is hard. Without an AR:
- You cannot register or sell your device legally
- It’s hard to talk to the Medical Device Authority due to language or time differences
- You may miss important updates or deadlines
A trusted AR makes this process smoother. They handle local steps, so you can focus on your business.
What Your Authorised Representative Will Do
A good AR supports every step of your compliance journey. Here’s what they handle:
- Classify your device and pick the right registration path
- Prepare and submit key documents like the Declaration of Conformity
- Submitting and maintaining Technical Documentation and Essential Principles
- Report issues with your product and manage corrective actions
- Help keep track of products and respond to market feedback
How Our Authorised Representative Service Helps You
We support foreign medical device companies that want to sell products in Malaysia. Our service makes registration clear, quick, and stress-free.
Expert Support From Start to Finish
We guide you through:
- Choosing the correct classfication
- Prepare clean, complete documents
- Staying on track with deadlines
We Handle the Full Registration Process
From gathering documents to submitting in MeDC@St, we do it all. You don’t need to learn local systems. We’ve got it covered.
Ongoing Regulatory Help
Even after the registration, we’re here to support:
- Renewal reminders and updates
- Reporting product issues
- Sharing important changes from Medical Device Authority
Your Local Partner on the Ground
We respond quickly to government requests. We keep you informed and help you stay compliant without extra hassle.
Why Choose Us?
- Established presence in Malaysia with in-depth understanding of Medical Device Authority processes, regulatory expectations and submission pathways
- Extensive experience supporting a diverse portfolio of medical devices, spanning various risk classes, use cases and regulatory pathways
- A collaborative and responsive approach that prioritizes clear communication, regulatory integrity and timely support throughout your product’s lifecycle
Ready to Register Your Medical Device in Malaysia?
We’ll help you get your product on the market, meet every requirement, and avoid costly delays.
Contact us today to start your registration and choose the right Authorised Representative in Malaysia.