MALAYSIA · MEDICAL DEVICES

Malaysia change notification: MDA GD/0020 categories and GD/0072

A European manufacturer moves sterilisation of a Class B infusion pump to a new subcontractor, releases a software update and, while reprinting the carton, updates the manufacturer’s address. The commercial team considers the product unchanged and wants the next Malaysian shipment to carry the new version. The authorised representative (AR) sees three different things: a change that can be implemented once complete documents are submitted, one that must wait for MDA endorsement, and fees and review time that add up when changes are filed together.

In Malaysia the question is rarely whether to notify a change; it is how to place each change in the right category before shipping and build the MDA review period into the supply plan.

Which changes can be implemented on submission, which need prior endorsement, and which need a new registration?

Post-registration changes to general medical devices (GMD) and in vitro diagnostic devices (IVD) in Malaysia are still governed by MDA/GD/0020, Change Notification for Registered Medical Device, which uses three categories. Category 1 changes affect safety and performance and require a new registration: a change to intended purpose or indications, a change in risk classification, software changes affecting safety and performance, a change to the medicinal substance in a combination device (referred to NPRA), and devices with different proprietary names added outside the grouping criteria. Category 2 changes need MDA evaluation and endorsement before implementation: a change of manufacturing site, sterilisation method or parameters, an IVD moving from quantitative to qualitative, a change of coating material, or adding or removing a contraindication or warning. Category 3 changes may be implemented once complete documents are submitted through MeDC@St: software version changes not affecting safety or performance (consolidated for up to six months), reduced indications for non-safety reasons, added approvals from recognised countries such as CE marking, and a manufacturer name or address change that is not the manufacturing site. (Source: MDA/GD/0020 Change Notification for Registered Medical Device, 4th Ed, 2022-11-21)

The MDA guidance list currently shows GD/0020 at its Fourth Edition (21 November 2022). MDA’s change notification page adds that notifications are made within the registration validity period and that, where the MeDC@St 2.0+ system and the guidance differ, the guidance prevails. (Source: MDA Guidance Document list, 2026-05-22; MDA Change Notification page, 2025-10-16)

How are fees and review times calculated, and how many certificates can one notification cover?

Fees under GD/0020 depend on risk class. Category 2: Class A RM50, B RM500, C RM1,000, D RM1,500 and RM2,500 for a device containing a medicinal product; Category 3: RM30, payable before MDA endorsement or acknowledgement; where several categories or submission IDs are involved, fees add up. Under Table 5 of the Fourth Edition, a single submission ID for a Category 2 or Category 3 change takes 30 working days; Categories 2 and 3 combined, or multiple submission IDs, take 60 working days, counted from a complete submission. (Source: MDA/GD/0020, 4th Ed, 2022-11-21, Table 5)

Where the category is unclear, the registration holder may ask MDA to confirm it using the Annex A template (processing fee RM150). For borderline sterilisation or material changes this is usually more predictable than filing under Category 3 and being asked to re-file. (Source: MDA/GD/0020, 4th Ed, 2022-11-21, Annex A)

How does the GD/0072 significant/non-significant model differ from the current three categories?

MDA/GD/0072, Change Management for Registered Medical Devices, First Edition (May 2026), replaces the three categories with significant and non-significant changes. A significant change could reasonably be expected to affect the safety and/or performance of the device and requires MDA approval before implementation. Non-significant changes have three outcomes: notification required (implement on submission of complete documentation through MeDC@St), notification optional, and no submission (record in the QMS or technical documentation). Seven flowcharts (A–G) cover manufacturing/facility/QMS, design, sterilisation, software, materials (GMD and IVD separately), labelling and registration information. New-registration triggers sit in Section 5.6 (intended use, risk class, grouping, proprietary names); Section 5.3 lists cases requiring a new UDI-DI. (Source: MDA/GD/0072 Change Management for Registered Medical Devices, 1st Ed, 2026-05, §3.9, §3.13, §5.2–5.6, Tables 1–2)

Fees are largely carried over: significant changes Class A RM50, B RM500, C RM1,000, D RM1,500, drug-device RM2,500; non-significant changes requiring notification RM30. Review times are shorter: 10 working days for a single significant change type, up to 45 working days for several change types or several applications, and none for non-significant changes. Section 12 allows original-version stock to remain on the market after approval if still compliant and MDA is periodically informed of quantities and distribution status; newly imported devices must carry the updated information, and changes resulting from a field corrective action may be implemented immediately. (Source: MDA/GD/0072, 2026-05, §10 Tables 3–4, §11 Table 5, §12)

When does GD/0072 take effect, and which rules should files be prepared against now?

In its December 2025 public-comment announcement, MDA stated that the new guidance is intended to replace GD/0020 and will be enforced together with the launch of MeDC@St 3.0. Neither the announcement nor the published First Edition gives a date, and the guidance contains no effective-date clause. (Source: MDA Announcement: Public Comment, Change Management for Registered Medical Devices, 2025-12-03; MDA/GD/0072, 2026-05, Preface)

In MediPass’s current filing experience, Malaysian change notifications still run on MeDC@St 2.0 under GD/0020. The practical position is to classify current submissions under the three categories while organising the internal change assessment along the GD/0072 flowcharts, so the analysis need not be redone when the system switches.

How do change notifications interact with re-registration and a change of AR?

Registration is valid for five years and the re-registration button appears in MeDC@St within one year before expiry. GL/08 states that re-registration cannot be submitted at the same time as a change notification, and the file must include change notification approval letters or a declaration that there are none, so pending changes must be cleared first. GD/0072 Section 7 (applicable once it takes effect with MeDC@St 3.0) adds that QMS and PMS information (for Classes B–D also the CER/CPR, risk management report and CAB report) must be updated through the change management module during the certificate’s validity; re-registration cannot proceed if any item is outdated. (Source: MDA/GL/08 Re-registration Guideline, 2nd Ed, 2022-09, §1.3, §4, §5.2.12; MDA/GD/0072, 2026-05, §7)

A change of authorised representative is not a change notification. It follows the change-of-ownership route in MDA/GD/0041, with its own procedure and fees, and should be scheduled separately when a distribution network is restructured. (Source: MDA Guidance Document list, 2026-05-22)

What does this mean for project planning?

Classify first, then sequence. Hypothetical scenario: a manufacturer plans to ship a revised device to Malaysia in three months. The sterilisation site change is Category 2, so 30 working days of review must be reserved and the new version cannot ship before endorsement; a user-interface software update is Category 3 and can be implemented once complete documents are submitted and paid (filed together, the two changes take 60 working days); an extension of intended use goes straight to a new registration. The manufacturer owns classification and technical documentation; the registration holder (usually the AR) owns the MeDC@St submission, payment and MDA correspondence, so the change control procedure should fix when the AR is informed.