How to Choose an Authorized Representative in Malaysia: 10 Questions
Appointing an Authorized Representative (AR) is usually treated as an administrative step but in reality it is closer to a structural step.An AR holds your product registration in which their name appears on your regulatory file, their establishment license sustains your market access; and if the relationship ends, their cooperation determines how easily you can restructure. Manufacturers who choose too quickly often spend years managing the consequences.
Kindly be informed that this is not an explanation of what an AR does, that is covered separately. This article is regarding the list of questions to take into account before you sign.
1. Do you hold a current establishment licensee, and may I see it?
Every establishment dealing with medical devices in Malaysia must hold an establishment license, including an AR to act as registration holder.Ask for the license number and the expiry date. It is verifiable, and any legitimate AR will supply it without hesitation. An AR whose license lapses is a problem that becomes yours.
2. Are you GDPMD certified?
Good Distribution Practice for Medical Devices (GDPMD) certification underpins the quality system your AR operates. Ask for the certificate and the certification body.3. Do you distribute medical devices commercially?
This is the question most manufacturers do not ask, and the one that determines the most.Where your AR is also a distributor, the party holding your registration has a commercial interest in who sells your product. That is workable with a single long-term exclusive partner. It becomes a constraint the moment you want a second distributor, a different channel, or a different partner entirely.
An AR with no distribution interest has no interest in those decisions.
4. Do you represent products that compete with mine?
If your AR is also a distributer, ask what other products do they carry. An AR holding registrations for two competing product lines could potentially cause a conflict, whether or not they describe it that way.5. What happens to my registration if I want to change representatives?
The answer tells you a great deal.Transferring a registration requires the outgoing AR to sign a declaration and issue a termination letter. Without those, the transfer could not proceed. Ask directly what their process is, how long they commit to, and whether it is in the contract.
6. Will you commit to transfer cooperation in writing?
Follow the previous question with this one. The commitment should be a contractual term with a stated number of days, not goodwill.This should be negotiated at appointment and would be close to impossible to negotiate later when the relationship is nearing its end.
7. What access do I have to my own records?
Distribution records, complaints, adverse events and MDA correspondence should be available to you on request throughout the relationship, not only at exit.An AR who has never shown you the records is being asked at termination to reveal problems and hand over files simultaneously, which would potentially pose as a cause for delays.
8. Who actually does the regulatory work?
Ask who prepares the submission, who handles MDA queries, and what their background is. Some AR arrangements are administrative shells subcontracting the technical work. That may be fine, but you should be informed of this.Ask also how many registrations they currently hold and in which classes. Experience with Class A devices does not demonstrate capability with Class C devices.
9. How do you handle post-market obligations?
Registration is the beginning. Complaint handling, adverse event reporting and field safety corrective actions are continuing obligations, and your AR bears these obligations in Malaysia.Ask what their reporting process is and how quickly they escalate to you. A manufacturer who learns about an adverse event through the regulator rather than their own AR representative would be in a predicament.
10. What are the total costs, and what triggers them?
Beyond the annual fee, establish what is charged for submissions, variations, renewals, MDA queries, post-market reporting and transfer out, while transferring out is worth asking about explicitly.What good answers look like
A capable AR will supply their license and certification evidence without being pressed, explain their conflict position plainly, put transfer cooperation in the contract, name the person doing the work, and quote a fee structure with no surprises at exit.Hesitation on questions 3, 5 and 6 is the most informative signal in the list, because those three determine what happens when you want to leave.
Frequently asked questions
Can I appoint more than one Authorized Representative? Malaysia has permitted more than one AR to register the same device since the MDA revoked Circular Letter No. 1/2014 in September 2021. Confirm the current position for your device class.Should my distributor be my Authorized Representative? It is common and sometimes appropriate, particularly with a single exclusive long-term partner. The consideration is that it links your regulatory access to a commercial relationship, which makes the two difficult to separate later.
What if my AR’s establishment license expires? Your market access depends on it. Ask for renewal dates and keep them in your own calendar.
How much should an AR cost? Fees vary with device class, portfolio size and scope. The more practical question is what the total cost of the relationship is across five years, including renewal and exit.
Conclusion
The instinct when appointing an Authorized Representative is to look for speed and price. Both matter, but neither is what you will think about in three years.What you will think about is whether the arrangement still fits and whether the party holding your registration makes changing the registration holder straightforward or difficult. That should be determined at appointment, and not at exit.
Looking for an Authorized Representative in Malaysia?
DuoGate acts as an independent Authorized Representative and license holder for foreign medical device and IVD manufacturers. We hold no distribution interest in any product we represent, our transfer cooperation terms are contractual, and our fee structure has no exit charge.
If you are comparing representatives, we are happy to answer all ten questions above in writing.
Contact us to discuss your portfolio.
