Last verified against the official MDA portal: 9 August 2026. This page is updated whenever MDA publishes a consequential change.
August 2026 · UPCOMINGHologram Security Label (HSL) for registered medical devices
MDA will roll out a hologram security label for registered medical devices in phases, prioritising retail diagnostics (pulse oximeters, glucose and blood-pressure monitors) and high-risk implantables (pacemakers, heart valves, defibrillators, stents). Full implementation details are scheduled to be announced at the International Medical Device Exhibition and Conference on 26 August 2026.
What to do: If you supply retail diagnostic or implantable devices, budget for label integration and watch the 26 August announcement for timelines. The scheme mirrors the FarmaTag hologram used for pharmaceuticals since 2005.
Official source: MDA press release →
1 August 2026 · IN FORCEProduct classification applications are now fully online
From 1 August 2026 all product classification applications must be submitted through MDA’s online Product Classification Application System — the previous Google Form route is closed, and approval letters are now issued by email only (no more hard copies).
What to do: Route new classification requests through the online system and make sure the applicant email address is monitored — the official classification letter arrives there. Enquiries: classification@mda.gov.my / 03-8230 0376.
Official source: MDA announcement →
10 July 2026 · IN FORCEAutomated re-registration route introduced in MeDC@St 2.0+
MDA’s Pre-Market Control Division announced an automated re-registration route in MeDC@St 2.0+ on 10 July 2026, designed to streamline market access and keep registered devices in continuous supply across the 5-year renewal cycle.
What to do: If registrations in your portfolio expire soon, check whether they qualify for the automated route before preparing a conventional re-registration dossier — it can materially shorten renewal work.
Official source: MDA announcement →
1 July – 30 September 2026 · IN FORCEMalaysia–China Joint Evaluation Pilot Programme, Phase 2
Phase 2 of the Malaysia–China joint evaluation pilot runs from 1 July to 30 September 2026, continuing regulatory cooperation on device evaluation between MDA and China’s NMPA.
What to do: Manufacturers with Chinese approvals or China market plans should watch this pilot — joint evaluation pathways can shorten time-to-market in both directions.
Official source: MDA announcement →
Q2–Q3 2026 · UPCOMINGMeDC@St 3.0 rollout — establishment licensing, registration, CAB and change management go next-gen
MeDC@St 3.0, MDA’s ~RM20 million rebuild of its online application system, launches its core modules in stages through Q2–Q3 2026 — Phase 1 digitalises establishment licensing, product registration, CAB applications and change management, with nine new modules including AI-assisted processing, cloud infrastructure and a chatbot.
What to do: Expect submission workflows to change as modules cut over. The new UDI guidance and the GD/0072 change-management regime are both timed to this launch — see the entries below.
Official source: MDA news →
19 May 2026 · PUBLISHED · NOT YET IN FORCEMDA/GD/0072 — Change Management for Registered Medical Devices (1st edition)
MDA published the first edition of MDA/GD/0072, a risk-based framework for assessing, documenting and reporting post-registration changes — but it is not yet in force: MDA/GD/0020 (Change Notification) continues to apply until MeDC@St 3.0 launches.
What to do: Keep filing change notifications under GD/0020 for now, but map your change-control SOP against GD/0072 today so the switch is a form change, not a system change.
Official source: MDA announcement →
1 May 2026 · IN FORCEJoint announcement: MDA and Thai FDA regulatory cooperation
MDA and the Thai Food and Drug Administration issued a joint announcement on 1 May 2026 on medical device regulatory cooperation between the two ASEAN authorities.
What to do: Exporters covering both markets should watch for reliance or work-sharing pathways emerging from this cooperation — one dossier serving two ASEAN submissions is the direction of travel.
Official source: MDA announcement →
March 2026 · IN FORCEThree guidance documents revised or introduced
MDA published a second edition of “Definition of Medical Devices” (MDA/GD/0006), a third edition of the special-access exemption guidance for unregistered devices (MDA/GD/0043), and a first-edition guidance on confirmation of obsolete and discontinued devices (MDA/GD/0071) in March 2026.
What to do: Re-check borderline products against the new GD/0006 definitions, and use GD/0071 if you need formal confirmation that a legacy device is obsolete or discontinued — it now has a defined route.
Official source: MDA announcements →
28 January 2026 · IN FORCECircular No. 1/2026 — establishment licence now compulsory for tender participation
Under Circular Letter No. 1/2026, in force since 28 January 2026, every tenderer must hold a valid MDA establishment licence before participating in any new tender for medical devices — non-compliance is an offence under Section 15 of Act 737. Transitional exemptions cover tenders awarded, LOAs received, or tender advertisements issued before 28 January 2026, until the existing contract or tender activity ends.
What to do: If you bid for hospital or government supply contracts without an establishment licence, you are now locked out of new tenders. Licensing takes months — start before the next tender cycle, not after it opens.
Official source: MDA implementation notice (5 March 2026) →
Why we publish this
AA Alive holds its own MDA establishment licence (MDA-6798-K124) and runs the same GDPMD system it builds for clients, so every rule above lands on our desk before it lands on this page. If one of these changes affects your licence, registration or tender eligibility, the fix is usually cheaper before the deadline than after it.
Jawapan ringkas · Bahasa MalaysiaApa peraturan terbaru MDA pada 2026?
Antara perubahan utama MDA 2026: lesen establishmen kini wajib untuk menyertai tender peranti perubatan (Pekeliling Bil. 1/2026, berkuat kuasa 28 Januari 2026); permohonan klasifikasi produk kini sepenuhnya dalam talian (mulai 1 Ogos 2026); MeDC@St 3.0 sedang dilancarkan berperingkat; dan label keselamatan hologram akan diperkenalkan secara berfasa. Perlukan bantuan pematuhan? WhatsApp kami di 010-206 2070.