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Malaysia Authorized
Regulatory Representation
for Medical Devices (AR)

Choose Your Representative

Carefully. Choose Kazami.

Medical device manufacturers without a registered and licensed office in Malaysia must select an in-country representative, called a Malaysia Authorized Representative (AR). Your Malaysian Authorized Representative serves as your liaison with Malaysia’s Medical Device Authority (MDA) and is responsible for submitting your medical device registration, so it is important to choose your representative carefully.

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Malaysia Authorized Representative Requirements

The AR must be a citizen or permanent resident of Malaysia. The representative must also hold an Establishment License and a certificate of Good Distribution Practices, Medical Devices (GDPMD). Your medical device registration is submitted by the authorized representative, and the Conformity Assessment Body (CAB) certification is issued in the name of your representative.

As an independent representative with a presence in Malaysia, Kazami can act as your Malaysia Authorized Representative, which allows you to control your device approval.

Advantanges of AR

Can Your Distributor Serve as Your Authorized Representative to The MDA in Malaysia?

Many medical device manufacturers consider appointing a distributor as their Malaysia Authorized Representative. But this can be risky. Distributors focus on sales and marketing, rather than new and changing regulatory issues. Your Malaysian Authorized Representative also controls your device approval, so changing representatives can be difficult.

We recommend selecting an independent authorized representative that is committed to ensuring your firm stays ahead of regulatory requirements in Malaysia. Read more about the benefits of hiring an independent authorized representative.

Authorized Representative
Services Include:

  • Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
  • Regulatory monitoring to alert you to any changes or new regulation applicable to your product
  • License holding
  • Adverse event reporting and management
  • Product alert and recall tracking
  • Complaint handling

We Also Offer
Additional Support Services
Such as:

  • Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
  • Online regulatory training

Here’s How We Can Help:

Act as your primary regulatory contact with the MDA, from registration to post-market activities

Submit all necessary medical device registration documents to the CAB and MDA and assist with any follow-up questions

Add distributors allowed to import products

Assist in adverse event reporting to MDA and device recalls

If desired, we can use your Malaysia registration dossier to ease your entry into additional Southeast Asian medical device markets

Malaysia Medical Device Authorized Representative

Medical Device manufacturer without local presence in Malaysia requires In country representative known as Medical Device authorized representative, who will be a liaison between manufacturer and the Medical Device Authority (MDA) for registration and submitting the application.

MeDC@St is a web-based Medical Device Centralised Online Application System for registration with the MDA, for Establishment Licensing, Medical Device Registration and Export Permit. It can only be done by a local Authorized Representative. The representative must have an establishment licence and a certificate of Good Distribution Practices, Medical Devices (GDPMD).

Common Questions

We are marketing multiple products in Malaysia. Can we appoint more than one authorized representative?

Yes. Manufacturers with multiple devices can appoint a different representative for each device. You may only appoint one representative per device.

Is possible to transfer our MDA registration to a different representative?

Yes, registrations may be transferred to another AR with the agreement of your current AR.

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