C. Y. Chin, Business Development Director | Infinity Pharmacare | September 2026
The company you want to remove is the company that has to sign you out. Under MDA/GD/0041, section 4.2 places three deliverables in the outgoing AR’s hands. Your incoming AR cannot produce any of them, and neither can you.
A change of Authorised Representative in Malaysia is processed as a change of ownership of the device registration, with a target turnaround of approximately thirty working days on a complete submission. The fee is RM500 per medical device registration ID, paid by the new AR. The outgoing AR must complete and sign the Annex B Current AR Declaration Form, surrender all applicable device certificates to the Authority, and transfer all distribution and complaint records up to the approval date to the new AR. Those three items are sourced from the outgoing AR alone.
What is a change of Authorised Representative under MDA/GD/0041?
The governing document is MDA/GD/0041, Change of Ownership for Medical Device Registration, First Edition, December 2016. Nearly ten years on, no later edition has been issued.
Replacing an AR is not a fresh registration. It is processed as a change of ownership of the registration you already hold, which is why the registration itself carries over rather than starting again. Who holds that registration in the first place is a separate decision, and it turns on how the AR role differs from a distributor.
Three conditions sit at the front of the file. The registration must already be approved. No pending applications may sit in the system against it, and anything pending has to be completed or withdrawn before the change goes in. The target turnaround is approximately thirty working days on a complete submission, which is the only timing figure the guidance commits to.
The pending applications condition does more damage than it looks. One application sitting half finished in the system is enough to hold the whole change, and the party that filed it is usually the party you are trying to remove. Clear the system before you give notice, not after.
The fee is RM500 per medical device registration ID, paid by the new AR by bank draft as specified in Annex A. It appears in the running text at page 6 and again in the Annex A checklist at page 8. Per registration ID is the phrase to read slowly. Forty registrations means forty fees. The current AR receives no refund of registration fees it has already paid, which quietly removes one bargaining chip you might have expected to use.
What does the incoming AR file?
Four documents, under section 4.1.
The Annex A application form, completed and signed. The new AR’s establishment licence. A Letter of Authorisation from the foreign manufacturer. And an official manufacturer letter requesting the change, stating the new AR’s effective appointment date and listing the applicable registered devices.
One detail in that letter decides whether the file is clean. The guidance states that the effective appointment date should be before the submission date. Appoint first, then file. Not the other way round.
What must the outgoing Authorised Representative produce?
Section 4.2 lists three items. Every one of them is a positive act by the party being removed.
First, the Annex B Current AR Declaration Form, completed and signed. This is a signature from the outgoing AR on a form only the outgoing AR can sign. The guidance describes no version executed by the manufacturer in its place.
Second, surrender of all applicable device certificates to the Authority. Those certificates sit with the outgoing AR. They go back to MDA, not across to your new AR, and the surrender is written as an act of the current AR rather than something MDA performs on its own record.
Third, transfer of all distribution and complaint records up to the approval date, to the new AR. These are commercial and safety records held inside that company’s systems, and they move directly to the incoming party.
Read the three together and the shape is obvious. One signature, one physical surrender, one data transfer, all sourced from a single company, none of them substitutable by anyone else.
The third item carries more weight than the list suggests. The incoming AR’s own declaration at Annex A, item iii, has it declaring that it takes possession of the distribution and complaint records, that it will maintain them in accordance with GDPMD and device safety requirements, and that it will produce them to MDA on request or during a field safety corrective action. Your new AR signs for possession of records it can only obtain from the company it is replacing. GD/0027 section 4.6 c points the same direction in one narrow case: where an AR closes its business after placing a device on the market and is replaced, the newly appointed AR carries post market responsibility. The clause is written for closure. It does not speak to a transfer between two companies that are both still trading.
So this is not a handover of a certificate. It is a handover of the evidence base sitting behind your device in Malaysia, and the outgoing AR is the one holding it.
What happens if the outgoing Authorised Representative refuses?
MDA/GD/0041 describes a transfer between two cooperating parties. It contains no procedure, no remedy and no escalation route for an outgoing AR that refuses, fails or is unable to provide the section 4.2 declaration, the certificates or the records. That absence is a finding, not a gap in the reading. The document does not address the situation at all.
The obvious alternative closes the same way. Termination without a replacement, under GD/0027 section 8.7.1, requires an official termination letter signed by the AR’s Person Responsible on AR letterhead, submitted together with the manufacturer’s termination letter signed by manufacturer top management on manufacturer letterhead. Both letters are required. Walking away instead of transferring does not remove the outgoing AR’s signature from the file. Notice the sequence that creates. The route to a new AR and the route out of the relationship entirely both run through the same Person Responsible at the same company.
There is a third document in the picture. The template Letter of Authorisation at GD/0027 Annex B.1 states that the authorisation remains in effect until the manufacturer notifies MDA in writing that the authorisation is revoked, subject to any condition imposed by the Authority. The same template notes that non compliance with any condition imposed by MDA may result in suspension or cancellation of the device registration.
On its face, that gives the manufacturer a unilateral act. What the guidance does not say is how that act interacts with the section 4.2 requirement that the outgoing AR surrender certificates and sign a declaration. Revocation of authority and surrender of certificates sit in two separate documents, written for two separate purposes, and nothing in either one joins them. There is also no stated position on whether a registration survives, lapses or is cancelled while a transfer sits incomplete.
Treat that silence as silence. If your plan depends on revoking the Letter of Authorisation and proceeding without the outgoing AR’s declaration, put the question to MDA in writing and get the answer in writing before you act on it. Something that reportedly worked for another manufacturer is not a stated position, and the exposure sits on your registration.
What survives the transfer?
The effective date of the change is MDA’s approval date. Not your appointment date, not your submission date.
From that date the current AR’s access rights to the device listing cease immediately. Section 6 writes in no wind down window. If your outgoing AR is your only route into the listing today, plan for the switch to be abrupt and get whatever you need out of that listing before approval lands.
The new AR assumes all duties under Act 737 and the Medical Device Regulations, including the post market obligations above, supported by the records transferred under section 4.2.
The registration itself continues from its original registration date. Validity does not restart, unless the Authority cancels the registration before expiry. That is the strongest practical reason to run a change of ownership properly rather than let a registration lapse and start again. You keep the clock you have already paid for.
What should an AR agreement require at appointment?
Everything above is settled by a contract signed long before anyone wants to leave.
Put a standing obligation in the AR agreement to execute change of ownership documents on request, and name them individually. The Annex B Current AR Declaration Form. Surrender of all applicable device certificates to the Authority. Transfer of all distribution and complaint records up to the approval date. A general cooperation clause does not survive a commercial dispute. A clause naming three specific documents is much harder to argue around.
Put a timeline against each one. The guidance gives MDA a thirty working day target and says nothing about how long the outgoing AR may take to sign. That number is yours to set, counted in working days from written notice.
Handle the pending applications condition while you still have cooperation. Nothing may sit pending against the registration when the change is filed, so the agreement should require the AR to complete or withdraw anything outstanding on notice, and to stop filing new applications once notice is given.
Require distribution and complaint records to be maintained in a form that can be transferred on demand, rather than reconstructed from somebody’s mailbox on the way out.
Then write in the consequences. Refusal to sign should be a defined breach with a defined remedy, because the regulatory framework supplies neither. The same problem on the pharmaceutical side sits with the Product Registration Holder and reads almost identically.
The manufacturers who need this article usually read it too late. The AR you are unhappy with now was appointed on terms that never contemplated this moment. Commercially the registration is yours. The signature that releases it is not.
This briefing is for general information only. It does not constitute legal, regulatory or medical advice. Regulatory requirements change. Verify all details against current official MDA guidance before making filing or commercial decisions.