MDA Malaysia, explained by a practice that holds its own MDA licence.
The Medical Device Authority decides who may trade medical devices in Malaysia and which devices may be sold. Here is how the system actually works — the licence, the registration, the CABs, the MeDC@St system and the 2026 rule changes — from consultants who face the same audits you do.
What MDA is and what it controls
The Medical Device Authority (Pihak Berkuasa Peranti Perubatan) is the Ministry of Health agency established under the Medical Device Authority Act 2012 to enforce the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. Its remit covers the entire life of a device on the Malaysian market:
- Establishment licensing — the licence every manufacturer, importer, distributor and authorised representative must hold (our licensing packages)
- Device registration — product-by-product approval, classed by risk A–D (how registration works)
- Conformity assessment — through registered CABs that audit GDPMD/ISO 13485 systems and verify Class B–D dossiers
- Post-market control — mandatory problem reporting, recalls, change notification, and from 2026 the phased hologram security label
- Enforcement — trading without a licence or registration is an offence under Act 737
How the pieces fit — licence first, devices second, renewals forever
Malaysian device regulation runs in one legal order. Your company first certifies a quality system (GDPMD for importers/distributors/ARs, ISO 13485-based for manufacturers) and obtains the establishment licence. Only then can devices be registered, one by one, by risk class. From the day of approval, three renewal clocks run — the quality system yearly, the licence every 3 years, each registration every 5. The home page walks the full chain with the published fee for every step, and all submissions travel through MeDC@St, MDA’s online application system.
| Risk class | Risk level | Typical devices | Route |
|---|---|---|---|
| Class A | Low | Wheelchairs, simple instruments | Notification — fastest |
| Class B | Low–moderate | Hospital beds, suction units | CAB verification + MDA review |
| Class C | Moderate–high | Ventilators, infusion pumps | CAB verification + MDA review |
| Class D | High | Implantables, life-supporting devices | Deepest evaluation — quoted per device |
Classification drives everything — the dossier, the fee, the timeline. Since 1 August 2026 classification applications are fully online. Unsure of your class? Classification review is included in our registration fees.
2026 changesThe rules moved this year. Here is the short version.
2026 is the busiest regulatory year since Act 737 came into force — a tender licensing mandate, a new submission platform, a new change-management regime and a physical anti-counterfeit label all landed within months of each other:
- August 2026: Hologram Security Label (HSL) for registered medical devices
- 1 August 2026: Product classification applications are now fully online
- 10 July 2026: Automated re-registration route introduced in MeDC@St 2.0+
- 1 July – 30 September 2026: Malaysia–China Joint Evaluation Pilot Programme, Phase 2
- Q2–Q3 2026: MeDC@St 3.0 rollout — establishment licensing, registration, CAB and change management go next-gen
- 19 May 2026: MDA/GD/0072 — Change Management for Registered Medical Devices (1st edition)
Each change is broken down — with the official MDA source and the action to take — on the MDA latest updates page (last verified 9 August 2026).
Contact pointsOfficial MDA channels
- Portal: www.mda.gov.my · Submissions: MeDC@St
- HQ: Level 6, Prima 9, Prima Avenue II, Persiaran APEC, 63000 Cyberjaya, Selangor · +603-8230 0300
- Industry facilitation: ebantuan@mda.gov.my · Classification: classification@mda.gov.my
MDA answers process questions; it does not prepare your dossier, fix your quality system or defend your submission. That is what we do — at published, all-inclusive prices.
Apa itu MDA Malaysia?
MDA (Pihak Berkuasa Peranti Perubatan) ialah agensi Kementerian Kesihatan yang mengawal selia peranti perubatan di Malaysia di bawah Akta 737. Syarikat perlu lesen establishmen sebelum boleh mengimport, mengedar atau mewakili peranti, dan setiap peranti perlu didaftarkan mengikut kelas risiko A–D melalui sistem MeDC@St. Kami uruskan kesemuanya — WhatsApp 010-206 2070.
Frequently asked questions
What is the MDA in Malaysia?
Who must be licensed by MDA?
What is the difference between MDA registration and an establishment licence?
What are CABs?
Is MDA approval the same as FDA or CE approval?
Need to get through MDA the first time?
We hold our own MDA establishment licence and have registered 1,000+ devices at a 98% approval rate. Tell us what you make or import — we will map your route through the Authority at a published price.