MDA change of ownership: switching the registration holder.

What change of ownership is.

Section 5(1) of Act 737 bars any medical device from being imported, exported or placed on the market unless it is registered, and section 6(1) says the registration application is made by an establishment. For a device made abroad, that establishment is the authorised representative (AR) the manufacturer appointed. So the registration sits with the AR. When the manufacturer wants a different AR, the registration has to move with it.

MDA handles that move as a change of ownership (COO), described in MDA/GD/0041, Change of Ownership for Medical Device Registration (First Edition, December 2016, made under MDA Circular Letter No. 3 Year 2016). It is the edition MDA’s guidance document list still carries, and MDA’s licensing page links it alongside its current MeDC@St 2.0 process flow. The new AR applies; the current AR declares and hands over; MDA approves; and the change takes effect on the approval date. The device keeps its registration and does not go back through conformity assessment.

When it applies

MDA/GD/0041 names four situations:

1. A foreign manufacturer has set up its own company in Malaysia and wants that company to take the registration over from its AR.
2. The manufacturer replaces its existing AR with a new AR.
3. A merger or acquisition.
4. The existing AR has closed its business.

It is not the route for changes to the device itself (that is change notification) or for changes to a company’s own licence details, which MDA handles as a licence amendment.

Before you apply

• The device must already be registered. COO transfers an existing registration; a device still under evaluation cannot change hands this way.
• No pending applications. MDA/GD/0041 requires that nothing is pending on the device in the system; any open application must be completed or withdrawn first.
• The new AR needs an establishment licence. It is on the document list, and the guidance tells a new AR without a MeDC@St account to create one and apply for a licence first (MDA/GL No. 2). The licence in turn needs a GDPMD certificate. See our establishment licence service.
• The manufacturer appoints the new AR first. The appointment date in the manufacturer’s letter must be before the date the application is submitted to MDA.

Documents each side provides

Both forms carry a declaration signed by a responsible person. Furnishing a declaration or document that is untrue, inaccurate or misleading is an offence under section 76 of Act 737, and both forms say so.

What the new AR declares

In the Annex A declaration the new AR accepts that it:

• accepts the manufacturer’s appointment and the duties and obligations of an AR for the listed devices;
• will comply with the registration’s conditions of approval;
• will take possession of the distribution and complaint records held by the current AR up to the approval date, keep them for the period the regulatory requirements and GDPMD set, and give them to MDA in a field safety corrective action or on request; and
• will fulfil the duties and obligations under Act 737 and its regulations.

The steps in MeDC@St 2.0

MDA/GD/0041 describes a 2016 process: forms emailed or faxed to MDA, with a bank draft for the fee. MDA’s current process flow for change of ownership, linked from its establishment licence page, runs in MeDC@St 2.0 in six steps:

1. Procure all the relevant documents.
2. Submit the application in MeDC@St 2.0.
3. Pay the application fee.
4. MDA assesses the application and decides.
5. Pay the COO fee.
6. MDA issues the product certificate, “with validity of 5 years”.

MDA lists change of ownership with the establishment licence applications (new, renewal, amendment, withdrawal), and its MeDC@St 2.0 navigation video is titled “Establishment License – Change of Ownership”. The application is still made by the new AR.

Fees and timing

The fee is per registration ID, so a manufacturer moving many registrations pays for each one. Check how your devices were grouped (see grouping) when you count.

After approval

• Both ARs are notified of the outcome, and the current AR’s access to the device listing ends immediately.
• The new AR takes on the duties and obligations under Act 737 and the regulations, including mandatory problem reporting, field corrective action and recalls and post-market surveillance.
• Stock already in the market carries the old AR’s details. Our labelling page covers relabelling when a registration changes owner.
• Distributors are appointed by the AR, so the new AR needs its own distribution arrangements and records from the effective date.

Certificate validity: two MDA statements

MDA/GD/0041 says the registration certificate’s validity continues from the initial date of registration unless MDA cancels the registration before it expires. MDA’s MeDC@St 2.0 flow ends with a product certificate issued “with validity of 5 years” and does not say from which date. They may describe the same thing (registration runs for 5 years from the original date), but the flow does not say so. Plan on the original expiry date and confirm with MDA when you file.

Timing matters because a device with an active COO application cannot use MDA’s Automated Re-Registration Route (from 13 July 2026), and re-registration opens one year before expiry. A change of ownership started in the last year of a registration can collide with the renewal window.

What MDA/GD/0041 does not settle

• An uncooperative or vanished current AR. The guidance lists an AR that has closed its business as a reason for COO, yet still asks for the current AR’s declaration and certificates. It does not describe a route without them. Ask MDA before filing.
• Fee amounts in MeDC@St 2.0. The 2016 guidance gives RM500 per registration ID; the current flow shows two payments without amounts.
• Certificate dates. See above.
• Contact details. The guidance still points to the old mdb.gov.my site and to email or fax submission. MDA’s portal is now portal.mda.gov.my and applications go through MeDC@St 2.0.

How we would plan a switch

This is our practice, not an MDA requirement:

1. Make sure the new AR’s establishment licence and GDPMD are in place before notice is given to the current AR.
2. Agree the hand-over with the current AR in writing: the Annex B declaration, certificate surrender and the record transfer up to the approval date.
3. Close or withdraw any pending change notification on the devices.
4. Check each registration’s expiry date, and finish the COO before the re-registration window if you can.
5. Line up relabelling and distributor appointments for the effective date, so supply does not stop.

Writing a transfer-cooperation clause into every AR agreement at the start avoids most of the trouble at the end.