Local Authorised Representative in Malaysia

Entering Malaysia’s medical device market can be a complex process, especially if you’re navigating it from abroad. That’s where Andaman Medical comes in.

As a trusted
Local Authorised Representative (LAR) in Malaysia since 2014, we provide the local expertise and hands-on support you need to ensure seamless market access and compliance. We take care of the complexities, so you can focus on delivering your medical innovations to the people who need them most.

Why Appoint a Local Authorised Representative in Malaysia?

Appointing a Local Authorised Representative (LAR) in Malaysia isn’t just about ticking a regulatory box, it’s about ensuring our medical device gains smooth market entry and achieves long-term success in this competitive market. Here is why having a Local Authorised Representative (LAR) in Malaysia is important:

At Andaman Medical, we specialise in providing reliable and expert services to support you. With our deep understanding of Malaysia’s regulatory landscape, we act as your trusted in-country representative, ensuring compliance with local regulations, managing communications with the Malaysian Medical Device Authority (MDA), and handling all necessary post-market activities.

Here is why having a Local Authorised Representative (LAR) in Malaysia is important:

Our Local Authorised Representative Services in Malaysia

Representation

Act as your company’s representative in all dealings with the Ministry of Health for medical devices and in-vitro diagnostics.

Authority

Manage all obligations under the Malaysian medical device regulatory system.

Experience

Provide expert support based on years of experience representing manufacturers and distributors.

Product Registration

Register your medical devices with the MDA.

Change Notifications

Submit change notifications as needed.

Licence Transfers

Handle the transfer of product licences.

Post-Market Surveillance

Ensure compliance with post-market surveillance requirements, including Mandatory Problem Reporting and Complaint Handling.

What You Need to Know About Having a Local Authorised Representative in Malaysia

To qualify as a Local Authorised Representative, a company must meet specific criteria outlined by the MDA:

Legal Entity

The company must be a registered entity in Malaysia.

Establishment Licence

Must hold a valid licence issued by the MDA. One licence for each establishment role policy from 1 July 2024.

Good Distribution Practices (GDP) Certification

The company must have a GDPMD certificate.

Qualified Personnel

Must employ individuals with expertise in medical device regulations and quality management.

Letter of Authorisation (LoA)

The foreign manufacturer must issue an LOA formally appointing the AR as their representative.

Appointment Rules

Multiple Authorised Representatives

As of June 17, 2021, the MDA allows foreign manufacturers to appoint multiple ARs for a single medical device, increasing flexibility and competition within the industry.

Letter of Authorisation

The foreign manufacturer must provide a Letter of Authorisation on official letterhead, signed and stamped by an officer of the company.

Transferability

A device’s licence can be transferred from one local authorised representative to another without a fixed appointment duration.
Navigating the role of a Local Authorised Representative in Malaysia can be complex, but Andaman Medical is here to simplify the process and ensure you remain fully compliant. Connect with our experts today and take the first step toward seamless representation!

Why Choose Andaman Medical for Your In-Country Representation in Malaysia?

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