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MDA · MDA/GD/0020 4th Edition · MDA/GD/0072 (pending MeDC@St 3.0)

MDA change notification for registered medical devices.

Changing a registered device, its manufacturing site, label or QMS certificate means telling MDA first, and some changes cannot be made until MDA endorses them. Here is how MDA/GD/0020 sorts changes, what each costs per certificate, how long reviews take, and what the replacement guidance MDA/GD/0072 will change.

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The three categories in MDA/GD/0020.

CategoryWhat it meansCan you implement it?Example
1Not eligible for change notificationOnly through a new registrationNew intended purpose, change of class
2Needs MDA evaluation and endorsementAfter MDA endorses itManufacturing process change that alters specifications
3NotificationAs soon as complete documents are submittedUpdated QMS certificate, IFU clarifications

The registration holder (the local manufacturer or authorised representative) submits through MeDC@St 2.0+. If the category is unclear, MDA will confirm it before you submit (Annex A of MDA/GD/0020): RM150, 30 working days.

Fees per registration certificate

ClassCategory 2Category 3
ARM50RM30
BRM500RM30
CRM1,000RM30
DRM1,500RM30
Device with a medicinal productRM2,500RM30

Fees are charged per registration certificate and added together. MDA’s worked example: a Category 2 and a Category 3 change on three Class B certificates costs 3 × (RM500 + RM30) = RM1,590. Under MDA/GD/0020 you pay before MDA endorses or acknowledges the change. These fees are set in the guidance; the Fifth Schedule has no change notification fee, and the 2026 amendment (P.U. (A) 330/2025) changed only Class A registration fees.

Review times and the 30-day withdrawal rule

  • 30 working days for a single submission ID.
  • 60 working days for combined categories or multiple submission IDs.
  • Since 1 April 2023, if MDA asks for information and the application is not completed within 30 working days, it is withdrawn and the fee is not refunded.

Changes that need a new registration

  • A change of intended purpose (except a reduction in indications not made for safety reasons).
  • A change of risk class.
  • Adding a device that is not a permissible variant under the Second Schedule and MDA/GD/0005 grouping rules.
  • Adding variants to a Class A/B IVD cluster (MDA/GD/0054).
  • Adding devices under a different proprietary name, unless grouping allows one listing.

Changes to an ancillary medicinal substance are referred to NPRA. If you are unsure whether a planned change is Category 1, check before you change the product, not after.

Coming next: MDA/GD/0072 change management

MDA published MDA/GD/0072, Change Management for Registered Medical Devices (First Edition) on 15 May 2026. It replaces MDA/GD/0020, but only after the official launch of MeDC@St 3.0; until then MDA/GD/0020 stays in force. No launch date had been announced by October 2026. When it applies:

  • Significant changes need MDA approval before the changed device is placed on the market: 10 working days for a single change, up to 45 working days for multiple changes or applications.
  • Non-significant changes are “notification required” (implemented on submission), “notification optional”, or recorded in the QMS only, with no review time.
  • Changes arising from a field corrective action may be implemented immediately.
  • Fees stay the same (RM50–RM2,500 significant, RM30 non-significant) but are paid after approval or acknowledgement.
  • New routes: a pre-approved change plan (PCCP) for software as a medical device, a replacement-reagent and instrument-grouping route for Class A/B IVDs, and updating device information before re-registration through the change module.

Changes and renewals

A pending change notification or change of ownership makes the device ineligible for MDA’s Automated Re-Registration Route. Plan changes so they are closed before the re-registration window opens one year before expiry. A change that alters the device’s claims also ends any advertisement approval based on them.

Jawapan ringkas · Bahasa Malaysia

Berapakah fi pemberitahuan perubahan (change notification) MDA?

Di bawah MDA/GD/0020 (Edisi Ke-4), fi Kategori 2 ialah RM50 (Kelas A), RM500 (Kelas B), RM1,000 (Kelas C), RM1,500 (Kelas D) atau RM2,500 (peranti dengan produk ubat), dan Kategori 3 ialah RM30, bagi setiap sijil pendaftaran. Tempoh semakan 30 hari bekerja bagi satu ID permohonan. WhatsApp 010-206 2070.

FAQ

Frequently asked questions

What is an MDA change notification?
It is how the registration holder tells the Medical Device Authority about a change to a registered medical device or its registered information, such as a new manufacturing site, a label or IFU revision, or an updated QMS certificate. The current guidance is MDA/GD/0020, Change Notification for Registered Medical Device, Fourth Edition (21 November 2022). It is submitted in MeDC@St 2.0+.
What are the change notification categories?
MDA/GD/0020 has three. Category 1 changes cannot go through change notification and need a new registration. Category 2 changes need MDA’s evaluation and endorsement before they are implemented. Category 3 changes may be implemented as soon as complete documents are submitted. If the category is unclear, MDA will confirm it for RM150 within 30 working days.
How much is the MDA change notification fee?
Under MDA/GD/0020, Category 2 costs RM50 (Class A), RM500 (Class B), RM1,000 (Class C), RM1,500 (Class D) or RM2,500 (device with a medicinal product), and Category 3 costs RM30, per registration certificate. Fees add up across certificates: one Category 2 and one Category 3 change on three Class B certificates is 3 × (RM500 + RM30) = RM1,590. These fees come from the guidance, not the Fifth Schedule, which the 2026 fee amendment did not touch for change notifications.
How long does MDA take to review a change notification?
30 working days for a single submission ID, and 60 working days for combined categories or multiple submission IDs (MDA/GD/0020, section 8). If MDA asks for information and the application is not completed within 30 working days, it is withdrawn and the fee is not refunded (in force since 1 April 2023).
Which changes need a new registration instead?
A change of intended purpose (a reduction in indications that is not for safety reasons is the exception), a change of risk class, adding a device that is not a permissible variant under the grouping rules (MDA/GD/0005), adding variants to an IVD cluster (MDA/GD/0054), and adding devices with a different proprietary name unless the grouping rules allow them on one listing.
What is MDA/GD/0072?
Change Management for Registered Medical Devices, First Edition, published 15 May 2026. It will replace MDA/GD/0020, but MDA’s announcement says it takes effect only after the official launch of MeDC@St 3.0; until then MDA/GD/0020 stays in force. No launch date has been announced as of October 2026.
Does a pending change notification affect re-registration?
Yes. A device with an active change notification or change of ownership application is not eligible for MDA’s Automated Re-Registration Route (from 13 July 2026). Clear pending changes before the re-registration window opens a year before expiry.

Planning a change to a registered device?

Tell us what is changing and which registration numbers it affects. We will confirm the category, prepare the submission in MeDC@St and keep your renewals and advertisement approvals clear of it.

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