However, business circumstances may change over time.
A manufacturer may want to replace its current AR, move the registration to its newly established Malaysian subsidiary, restructure after a merger or acquisition, or transfer the registration because the existing AR has stopped operating.
In Malaysia, this process is generally referred to as change of ownership for medical device registration.
This article explains when a change of ownership is required, who submits the application, what documents are usually needed, what the current AR and new AR must do, and what foreign manufacturers should consider before transferring medical device registration ownership in Malaysia.
Change of ownership refers to the transfer of an existing medical device registration from the current registration holder to a new registration holder.
For foreign-manufactured medical devices, this usually means transferring the registration from one AR to another AR, or from an appointed AR to the foreign manufacturer’s own Malaysian company after it has been established.
MDA’s guidance on change of ownership explains that medical device registration is the responsibility of the local manufacturer or the AR appointed by a foreign manufacturer. It also states that change of ownership may be required when a foreign manufacturer sets up a Malaysian company and wants to obtain ownership from the AR, when replacing an existing AR with a new AR, during mergers and acquisitions, or when the existing AR closes its business.
In simple terms, this process allows the registration to continue under a new responsible local party, provided the MDA requirements are met.
Medical device registration ownership is not just an administrative detail.
The registration holder has practical control over the local regulatory registration and is responsible for maintaining the registration, supporting regulatory communication, and managing relevant obligations with MDA.
For foreign manufacturers, the registration holder can affect:
- Control over market access;
- Distributor flexibility;
- Ability to appoint or replace distributors;
- Post-market communication;
- Complaint and adverse event records;
- Registration maintenance;
- Regulatory change management;
- Business continuity in Malaysia.
If a distributor or unsuitable partner holds the registration, the manufacturer may face difficulties later when trying to restructure the Malaysian market.
A change of ownership application may be required when the registration holder changes.
MDA identifies several common situations where change of ownership may be needed:
- A foreign manufacturer has set up a company in Malaysia and wants to obtain the ownership of the medical device registration from its current AR;
- The foreign manufacturer wants to replace the existing AR with a new AR;
- There are merger and acquisition activities;
- The existing AR has closed its business.
For example, a foreign manufacturer may initially use an independent license holder to enter Malaysia quickly. Later, after sales grow, it may incorporate its own Malaysian subsidiary and transfer the registration to that entity.
Alternatively, the manufacturer may have appointed a distributor as the registration holder but later decide to switch to an independent AR to avoid distributor lock-in.
Foreign manufacturers may consider transferring registration ownership in Malaysia when:
- The current AR is no longer suitable;
- The current distributor holds the registration, but commercial performance is weak;
- The manufacturer wants to appoint multiple distributors;
- The manufacturer wants to separate regulatory control from distributor sales activity;
- The current AR is unresponsive or difficult to work with;
- The manufacturer has established its own Malaysian company;
- The current AR is closing down;
- The manufacturer is restructuring after acquisition;
- There is a change in global regulatory strategy;
- The manufacturer wants better control over post-market compliance.
According to MDA’s change of ownership application information, the application shall be made by the new AR, and only duly completed application forms should be submitted to the Authority. MDA also states that the request should be made after the medical device is registered and there should be no pending applications in the system.
This is important.
The new AR should usually take the lead in submitting the change of ownership application, while the current AR and foreign manufacturer provide supporting documents and confirmations.
In practice, this means all parties should coordinate before submission:
- Foreign manufacturer;
- Current AR;
- New AR;
- Existing importer or distributor, if relevant;
- Internal regulatory and commercial teams.
MDA’s application information states that a request to change ownership shall be made after the medical device is registered and that there shall be no pending applications in the system. Otherwise, the applications would be required to be completed or withdrawn.
This means manufacturers should check whether there are any pending matters before starting the transfer process.
Pending applications may include:
- New registration applications;
- Re-registration applications;
- Change notification applications;
- Amendment-related submissions;
- Other incomplete submissions in the system.
MDA states that the new AR is required to pay a service or processing fee of RM500 per medical device registration ID for the change of ownership application.
This is the official processing fee stated by MDA for the change of ownership application.
However, foreign manufacturers should also budget for other possible costs, such as:
- New AR service fee;
- Regulatory consulting fee;
- Document preparation fee;
- Legal agreement review;
- Translation or notarization, if applicable;
- Post-market record transfer coordination;
- Distributor authorization updates;
- Labelling update assessment, if required.
Step 1: Confirm the Reason for Transfer
The first step is to identify the reason for the ownership transfer.
Common reasons include:
- Replacing the current AR;
- Transferring registration to the manufacturer’s new Malaysian company;
- Restructuring after merger or acquisition;
- Current AR closing its business;
- Moving from distributor-held registration to an independent license holder model.
Before starting the transfer, the manufacturer should review the existing registration status.
Check:
- Product registration ID;
- Registration validity;
- Approved device name;
- Approved models and accessories;
- Risk class;
- Manufacturer details;
- Current AR details;
- Pending applications;
- Existing change notifications;
- Any unresolved MDA queries.
This review helps prevent avoidable delay.
The manufacturer should select and appoint a new AR in Malaysia.
The new AR should be properly licensed and capable of handling:
- Change of ownership application;
- Regulatory communication with MDA;
- Registration maintenance;
- Post-market obligations;
- Distributor and importer coordination;
- Future change notifications;
- Renewal or re-registration support, where applicable.
The current AR must usually cooperate in the transfer.
Based on MDA’s current AR declaration form in the change of ownership guidance, the current AR declares that it will transfer all distribution and complaint records up to the date of approval of the change application to the new AR, and will surrender all applicable medical device certificates to the Authority.
This is a very important part of the process.
If the current AR is uncooperative, the transfer may become more difficult and may require additional strategic handling.
Manufacturers should therefore always include clear transfer obligations in their original AR agreement.
The foreign manufacturer should prepare a clear authorization appointing the new AR.
The documents may include:
- Manufacturer letter appointing the new AR;
- Termination or withdrawal letter for the current AR, where applicable;
- Current AR declaration;
- New AR declaration;
- Existing registration information;
- Product list and registration IDs;
- Current registration certificates;
- Distribution and complaint records transfer confirmation;
- Company documents of the new AR;
- Any merger or acquisition documents, if relevant;
- Supporting explanation letter.
A change in AR may affect the local information displayed on labelling, instructions for use, packaging, importer/distributor documentation, or other market materials.
Separately, MDA’s change notification page states that change notification covers changes to registered medical device registration information, labelling, design or specifications, materials, manufacturing facility, process, and quality management system.
Depending on the exact changes, the manufacturer and new AR should assess whether additional change notifications or labelling updates are needed.
This assessment should be done before implementation to avoid compliance gaps.
The new AR submits the change of ownership application through the applicable MDA system.
MDA’s change of ownership page indicates that the application can be made via MeDC@St and that the new AR is responsible for the application.
The application should be complete before submission. Incomplete applications can cause delay or rejection.
The new AR should carefully check that all forms, declarations, product details, registration IDs, and supporting documents are correct.
The new AR pays the applicable MDA processing fee.
As noted above, MDA states the fee is RM500 per medical device registration ID.
For companies transferring multiple product registrations, the total official fee will depend on the number of registration IDs involved.
MDA may raise queries during the review.
Possible query topics include:
- Incomplete authorization documents;
- Missing current AR declaration;
- Inconsistent product registration details;
- Pending applications in the system;
- Unclear reason for transfer;
- Missing registration certificates;
- Missing records transfer confirmation;
- Issues related to new AR establishment license;
- Labelling or registration information changes.
Once MDA approves the change of ownership, the new AR becomes the registration holder for the affected medical device registration IDs.
After approval, the parties should complete the practical handover, including:
- Transfer of distribution records;
- Transfer of complaint records;
- Transfer of post-market records;
- Confirmation of registration certificates;
- Update of internal regulatory files;
- Notification to distributors and importers;
- Update of commercial authorization letters;
- Assessment of labelling updates;
- Post-market responsibility alignment;
- Future change notification planning.
The transfer should not only involve the registration certificate. It should also involve the regulatory and post-market history connected to the device.
Based on MDA’s current AR declaration form, the current AR declares that it will transfer all distribution and complaint records up to the date of approval of the change application to the new AR.
In practice, the record transfer may include:
- Distribution records;
- Complaint records;
- Adverse event records;
- Field safety corrective action records;
- Recall records;
- Importation and distribution history;
- Previous MDA correspondence;
- Approved registration information;
- Change notification history;
- Labelling versions;
- Distributor authorization records;
- Post-market surveillance information.
This can be one of the most difficult scenarios.
If the current AR refuses to cooperate, the manufacturer may face delays in obtaining declarations, records, or certificates needed for the transfer.
To reduce this risk, manufacturers should take preventive action before appointing any AR or distributor as registration holder by having a strong AR agreement.
A strong AR agreement should include:
- Clear obligation to cooperate with registration transfer;
- Requirement to surrender certificates when needed;
- Requirement to transfer complaint and distribution records;
- Timeline for cooperation after termination;
- Manufacturer ownership of regulatory documents;
- Confidentiality obligations;
- Non-obstruction clause;
- Clear termination process;
- Dispute resolution clause;
- Indemnity for refusal or delay, where appropriate.
These two processes are related but not the same.
Change of Ownership
Change of ownership is used when the registration ownership or registration holder changes.
Examples:
- Current AR changes to new AR;
- Distributor-held registration transfers to independent AR;
- AR transfers registration to manufacturer’s new Malaysian subsidiary;
- Existing AR closes and registration must move to another AR.
Change notification is used for changes made to a registered medical device within the validity period of registration.
MDA states that change notification is the process to notify the Authority of changes made to a registered medical device during the registration validity period. It includes changes such as manufacturing facility, process and QMS, design or specifications, materials, labelling, and registration information.
Depending on the situation, a change of ownership project may also trigger related change notification considerations, therefore the AR’s details, labelling, or registration information must be up-to-date.
A common situation is where a manufacturer originally allowed its Malaysian distributor to hold the registration.
At the beginning, this may seem convenient. The distributor may offer to handle the MDA registration, pay some costs, and manage local communication.
However, problems may arise later if:
- The distributor underperforms;
- The manufacturer wants to appoint more distributors;
- The distributor refuses to cooperate with additional distributors;
- The distributor controls regulatory access;
- The manufacturer wants to separate registration control from sales;
- The distributor focuses on competing brands;
- The manufacturer wants to restructure pricing or tender strategy.
Another common scenario is where the manufacturer initially enters Malaysia through an independent AR.
This is often a practical first step because it allows market entry without setting up a local company.
Later, if the Malaysian business becomes commercially significant, the manufacturer may set up its own local company and transfer the registration to that entity.
MDA specifically lists this as one of the reasons for change of ownership: a foreign manufacturer outside Malaysia has set up a company in Malaysia and intends to obtain ownership of medical device registration from the AR.
This staged approach can be commercially sensible:
- Start with independent AR to enter Malaysia quickly;
- Build distributor network and sales;
- Set up local subsidiary when revenue justifies it;
- Transfer registration ownership when ready.
Mistake 1: Waiting Until the Relationship Breaks Down Completely
If the current AR relationship has already deteriorated badly, transfer may become more difficult.
It is better to plan transfer before the situation becomes hostile.
Mistake 2: Not Checking Pending Applications
MDA requires no pending applications in the system before change of ownership proceeds. If there are pending applications, they must be completed or withdrawn.
Mistake 3: Forgetting Complaint and Distribution Records
The transfer is not only about the certificate. The current AR declaration refers to transferring distribution and complaint records to the new AR.
Mistake 4: Not Reviewing Labelling Impact
If AR details appear on labelling or IFU, the manufacturer must assess whether updates are needed.
Mistake 5: Not Clarifying Distributor Authorization
After the registration holder changes, distributor appointment letters and commercial authorization documents may also need to be updated.
Mistake 6: Assuming Transfer Is Automatic
Change of ownership requires an application and MDA processing. It should be planned properly.
Mistake 7: Not Including Transfer Clauses in the Original AR Agreement
This is a major commercial risk. Manufacturers should include clear transfer cooperation clauses from the beginning.
Before starting the process, foreign manufacturers should prepare or request:
- List of registered medical devices;
- Medical device registration IDs;
- Current registration certificates;
- Current AR agreement;
- Current distributor agreement, if the distributor is the registration holder;
- Manufacturer authorization letter for new AR;
- Termination or transition letter for current AR;
- Current AR declaration;
- New AR details and establishment license information;
- Complaint records;
- Distribution records;
- Adverse event and FSCA history;
- Change notification history;
- Labelling and IFU versions;
- Distributor and importer appointment records.
The timeline for change of ownership can depend on:
- Readiness of documents;
- Cooperation from current AR;
- Number of registration IDs;
- Whether there are pending applications;
- Whether labelling or registration information also needs to be updated;
- MDA query response time;
- Complexity of the commercial transition.
For example, if a manufacturer appoints a new distributor or announces a new AR before the transfer is complete, there may be confusion in the market.
A coordinated transition plan is better.
After MDA approves the change of ownership, the manufacturer should complete a structured transition.
Recommended actions include:
- Notify all appointed distributors;
- Notify importers, if different from distributors;
- Update authorization letters;
- Update internal regulatory database;
- Update labelling plan, if applicable;
- Transfer complaint records to the new AR;
- Confirm who handles adverse events and FSCAs;
- Update post-market contact points;
- Confirm importation and distribution arrangements;
- Review future product changes or renewals.
Before transferring medical device registration ownership in Malaysia, foreign manufacturers should ask:
- Why are we changing the registration holder?
- Is the current registration valid?
- Are there any pending applications in the MDA system?
- Is the current AR willing to cooperate?
- Does the current AR have all complaint and distribution records?
- Has the new AR been appointed formally?
- Does the new AR have the necessary establishment license?
- How many registration IDs are affected?
- What is the MDA fee for each registration ID?
- Are labelling or IFU updates required?
- Do distributor authorization letters need to be updated?
- Are importers and distributors aware of the planned transition?
- Are there any adverse events or FSCAs that must be disclosed?
- Are there any merger or acquisition documents involved?
- Do we need legal review of the current AR or distributor agreement?
1. Can medical device registration ownership be transferred in Malaysia?
Yes. Malaysia has a change of ownership process for medical device registration. MDA guidance explains that change of ownership may be required when a foreign manufacturer sets up a Malaysian company, replaces an existing Authorized Representative (AR), undergoes merger or acquisition activities, or where the existing AR closes its business.
2. Who applies for change of ownership?
The application is made by the new AR, and only duly completed application forms should be submitted to MDA.
3. Can change of ownership be submitted if there are pending applications?
MDA states that there shall be no pending applications in the system. Otherwise, the applications must be completed or withdrawn before the change of ownership request proceeds.
4. How much is the official MDA fee?
MDA states that the new AR is required to pay a service or processing fee of RM500 per medical device registration ID.
5. What records must the current AR transfer?
MDA’s current AR declaration form states that the current AR will transfer all distribution and complaint records up to the date of approval of the change application to the new AR, and surrender applicable medical device certificates to the Authority.
6. Is change of ownership the same as change notification?
No. Change of ownership deals with changing the registration holder. Change notification is used to notify MDA about changes made to a registered medical device during the registration validity period, such as changes to manufacturing facility, QMS, design, specifications, materials, labelling, or registration information.
7. Can a manufacturer transfer registration from a distributor to an independent license holder?
Yes, this may be possible through the change of ownership process, provided the requirements are met and the current registration holder cooperates as needed.
8. Why would a manufacturer transfer registration from a single distributor to an independent license holder?
The manufacturer may want to avoid distributor lock-in, appoint multiple distributors, separate regulatory control from commercial sales, or improve long-term market control in Malaysia.
9. Can a foreign manufacturer transfer registration to its own Malaysian company?
Yes, MDA specifically lists a scenario where a foreign manufacturer has set up a company in Malaysia and intends to obtain ownership of medical device registration from its AR.
10. What should be checked before starting the transfer?
The manufacturer should check registration validity, pending applications, current AR cooperation, required declarations, affected registration IDs, post-market records, distributor authorizations, labelling impact, and the readiness of the new AR.
Transferring medical device registration ownership in Malaysia is an important regulatory and commercial process for foreign manufacturers that want to change their authorized representative (AR), move registration to their own Malaysian company, restructure after a merger or acquisition, or replace a distributor that currently controls the registration.
The process should be carefully planned because the registration holder controls an important part of the manufacturer’s Malaysian market access.
According to MDA, change of ownership applications are submitted by the new AR, should be made when there are no pending applications in the system, and require a processing fee of RM500 per medical device registration ID. The current AR may also need to transfer distribution and complaint records and surrender applicable medical device certificates.
For foreign manufacturers, the best approach is to plan early, choose a reliable new AR, review existing agreements, confirm there are no pending applications, prepare all supporting documents, and manage the commercial handover carefully.
A well-managed transfer can help protect market continuity, reduce distributor lock-in, and give the manufacturer stronger long-term control over its Malaysian medical device business.
We support foreign medical device manufacturers with Malaysia authorized representative change, medical device license holder transfer, MDA change of ownership application support, registration maintenance, distributor coordination, and post-market compliance planning.
Whether you are replacing an existing authorized representative, moving from distributor-held registration to an independent license holder, or transferring registration to your own Malaysian company, our team can help you manage the process smoothly and strategically.
Contact us today to discuss your Malaysia medical device registration transfer requirements.
