Establishment roles · Published 29 August 2026

Who can hold your device registration in Malaysia.

A manufacturer outside Malaysia cannot register a device here directly — someone local has to hold it. Which of the four establishment roles that someone occupies determines who owns your market access, who answers to MDA, and what happens when the commercial relationship ends.

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01 Quality system + licence02 Product registration03 Renewals

Short answer. A foreign manufacturer must appoint a Malaysian authorised representative, and that AR holds the device registration and answers to MDA for it. The AR is one of four establishment roles under the Medical Device Act 2012, each of which needs its own establishment licence. Choosing the wrong one — usually by defaulting to your distributor — is how manufacturers lose control of their own registrations.

The four roles

Manufacturer, importer, distributor, authorised representative

The Act defines an establishment as a manufacturer, importer or distributor responsible for placing a medical device on the Malaysian market, plus an authorised representative appointed by a manufacturer whose principal place of business is outside Malaysia. Retailers are excluded.

Each of those roles needs its own establishment licence under Section 15. One company can hold several roles at once — most do — but the roles are distinct duties, not labels:

Role	What it does	Holds the registration?
Manufacturer	Makes the device (or has it made under its name)	Yes, if Malaysian
Authorised representative	Acts for a foreign manufacturer before MDA; the regulatory face of the device	Yes — this is the point of the role
Importer	Physically brings the device into Malaysia	Not unless it is also the AR
Distributor	Places the device on the market downstream	Not unless it is also the AR

The core rule

An overseas manufacturer cannot register directly

This surprises people, and it is the single most important fact on this page. If your principal place of business is outside Malaysia, there is no route by which you file your own registration. You appoint an authorised representative, that AR holds its own establishment licence, and the device is registered under the AR.

Which means: your Malaysian market access sits inside somebody else’s company. Everything below follows from that one structural fact.

The expensive mistake

Letting your distributor be your AR by default

It is convenient. Your distributor is keen, already knows the market, and offers to “handle the registration”. So they become your AR, and the registration for your device sits under their establishment.

Then the relationship ends — because it always eventually does. And:

The registration does not automatically follow you. It was granted to them, under their licence.
A new AR generally has to re-register the device under its own establishment, which is a fresh submission, not a name change.
You are out of the Malaysian market for the length of that gap, while your former distributor is not.
A disengaging AR has very little incentive to cooperate quickly with the transfer.

This is not an argument against distributors holding the AR role — plenty of good arrangements work exactly that way. It is an argument against doing it by accident, with no exit terms written down.

Two structural fixes are common. Either separate the roles — appoint an independent AR and let the distributor distribute — or keep them together but write the transition into the AR agreement at the start: what happens to the registration on termination, what cooperation is owed, and on what notice. Both are cheap in year one and priceless in year four.

Liability

What an authorised representative actually carries

An AR is not a mailbox. Under the Medical Device (Duties and Obligations of Establishments) Regulations 2019, whoever holds the registration carries the post-market obligations for that device:

Keeping the registration valid — renewal every five years, and no lapse in between
Change notification — currently under MDA/GD/0020, moving to the GD/0072 change-management regime when MeDC@St 3.0 goes live
Complaint handling — a documented process, with records that survive an inspection
Adverse event reporting — to MDA, within the prescribed timelines
Recalls and field corrective actions — the AR is the party MDA deals with
Distribution records and traceability — being able to say where a given unit went

For a manufacturer, the practical question is therefore not “who will sign the AR form” but “who can actually discharge these duties, and would survive an MDA inspection doing it?” An AR with no complaint procedure and no distribution records fails on your behalf, on your device, and you may not hear about it until the registration is in trouble.

Cost

What each route costs

The role you take determines the certification and licensing package, and we publish all of it:

Package	Who it is for	Fee
AR, importer & distributor	You hold devices for a foreign manufacturer and also import and distribute them	RM25,000 one-off
Importer & distributor	You bring devices in and sell them on, but are not the AR	RM18,000 one-off
GDPMD certification only	You already hold the licence, or only need the certificate	RM10,000 one-off
Establishment licence renewal	Everyone, every three years	RM9,000

The first two include GDPMD certification with CAB fees and the establishment licence submission with MeDC@St and MDA fees. Device registrations are separate, from RM2,500 for Class A — see full pricing.

Order of operations

You cannot appoint your way past the quality system

An AR is an establishment like any other, so it needs the same things in the same order: a certified quality management system first — ISO 13485 for manufacturers, GDPMD for distribution roles — then the establishment licence under Section 15, then the device registrations under Section 5, device by device.

A manufacturer looking for an AR should be asking to see the certificate and the licence number before signing anything. An establishment wanting to offer AR services should expect that question, and be able to answer it. We hold our own MDA establishment licence, which is the same test we would apply to anyone else — the law behind all of it is Act 737.

Jawapan ringkas · Bahasa Malaysia

Apakah wakil sah (authorised representative) peranti perubatan di Malaysia?

Wakil sah ialah syarikat Malaysia yang dilantik oleh pengilang luar negara untuk memegang pendaftaran peranti perubatan dan berurusan dengan MDA bagi pihaknya. Pengilang yang beroperasi di luar Malaysia tidak boleh mendaftar peranti secara terus — pelantikan wakil sah adalah satu-satunya laluan ke pasaran. Wakil sah mesti memegang lesen establishmen sendiri dan memikul tanggungjawab pasca pasaran: aduan, laporan kejadian buruk, penarikan balik dan rekod pengedaran. Pakej kami RM25,000 termasuk yuran CAB dan MDA — WhatsApp 010-206 2070.

FAQ

Frequently asked questions

What is an authorised representative for medical devices in Malaysia?

An authorised representative is the Malaysian entity a foreign manufacturer appoints to hold the device registration and answer to the Medical Device Authority on its behalf. A manufacturer based outside Malaysia cannot register a device directly, so appointing an authorised representative is the route to market. The AR is a defined category of establishment under the Medical Device Act 2012 and must hold its own establishment licence.

Can a foreign manufacturer register a device in Malaysia without a local representative?

No. The Act attaches the registration and licensing duties to an establishment placing the device on the Malaysian market, and a manufacturer whose principal place of business is outside Malaysia must appoint an authorised representative to act for it. There is no direct-registration route for an overseas entity. The practical consequence is that your Malaysian market access depends on the AR you choose, which is why the choice deserves more thought than it usually gets.

Can my distributor be my authorised representative?

Yes, and it is extremely common — but understand what you are agreeing to. If your distributor is also your AR, your distributor holds the registration for your device. If the commercial relationship ends, the registration does not automatically follow you, and re-registering under a new AR takes time you will be out of the market for. Many manufacturers deliberately separate the two roles, or appoint an independent AR, precisely to keep the registration under their own control.

What is the difference between an authorised representative and an importer?

The authorised representative is the regulatory face of a foreign manufacturer and holds the device registration; an importer is the establishment that physically brings the device into Malaysia. They are separate roles under the Act and one company can hold both, but they are not the same duty. An importer that is not the AR does not hold the registration, and an AR that never touches stock still carries the regulatory liability for the device.

Who is the licence holder for medical devices in Malaysia?

Every establishment that places a device on the Malaysian market holds its own establishment licence — manufacturer, importer, distributor or authorised representative. There is no single national licence holder and no way to trade on somebody else’s licence. Retailers are excluded from the establishment definition, so a pure retailer does not hold one, but that exclusion stops the moment you import your own stock.

What is an authorised representative liable for?

The AR carries the regulatory obligations for the device it registers: keeping the registration valid, notifying changes, handling complaints, reporting adverse events to MDA, and cooperating with field corrective actions and recalls under the Medical Device (Duties and Obligations of Establishments) Regulations 2019. It is not a nameplate role. An AR that cannot produce distribution records or has no complaint procedure fails an inspection on behalf of a manufacturer that may not even know it happened.

How do I change authorised representative in Malaysia?

Changing AR is not a transfer of paperwork — the incoming AR generally has to re-register the device under its own establishment, and the outgoing AR has to be dealt with in the existing registration. Plan for a gap. The single most useful thing a manufacturer can do is write the transition terms into the AR agreement at the start: what happens to the registration, what cooperation is owed, and on what notice. Doing it after the relationship has soured is how devices leave the market for months.

How much does it cost to appoint an authorised representative in Malaysia?

Our authorised representative, importer and distributor package is RM25,000 one-off, covering GDPMD certification including CAB fees and the establishment licence submission including MeDC@St and MDA fees. Without the AR scope, the importer and distributor package is RM18,000, and GDPMD certification on its own is RM10,000. Device registrations are priced separately by risk class, from RM2,500 for Class A.

Written by the regulatory team at AA Alive Sdn Bhd — a medical device practice that holds its own MDA establishment licence and has taken more than 1,000 devices through Malaysian registration. We file these submissions ourselves; the detail here is what we tell clients.

Keep reading

ISO 13485 certification in Malaysia: the whole process, start to certificate — What ISO 13485:2016 certification actually involves in Malaysia — who needs it, the seven stages from gap analysis to certificate, how long each takes, what it costs, and how it connects to your MDA establishment licence.
Medical Device Act 737: the law behind every Malaysian device approval — Malaysia regulates medical devices through two 2012 Acts and four sets of regulations. What Act 737 and Act 738 actually say, which duties fall on which establishment, and the sections MDA enforces in practice.

Need an authorised representative — or want to become one?

We act as authorised representative for foreign manufacturers, and we get Malaysian establishments licensed to do it themselves. Tell us which side you are on and we will quote a fixed price.

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