Medical device registration in Malaysia, done for you by an MDA-licensed team.

MDA registration service: what you get, what it costs, how long it takes

Prefer to do it in-house? Our free guide on how to register a medical device in Malaysia sets out the seven steps in order, and the classification guide covers the class rules in detail.

Registration under Act 737, end to end

Under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012, no medical device may be imported, exported or placed on the Malaysian market unless it is registered with the Medical Device Authority (MDA). Registration runs through MDA's online MeDC@St system and, for Class B–D devices, requires prior conformity assessment by a registered CAB.

We run the entire process as your regulatory team — not a form-filling service. That distinction matters at two moments: when the CAB or MDA raises queries, and two years later when you want the same dossier to carry a CE or FDA submission without starting over.

Registering in 2026: classification went online, renewals got faster.

Three changes worth knowing this year. Since 1 August 2026, product-classification applications are fully online and letters arrive by email. Since 1 October 2026, a new product classification letter is valid for 5 years (MDA announcement, 30 September 2026). And MDA's automated re-registration route (announced 10 July 2026) lets compliant registrations renew with far less resubmission work, which changes how we plan your 5-year renewal calendar. The new change-management guidance (MDA/GD/0072; see our guidance document list) is published but not yet in force — change notifications continue under GD/0020 until MeDC@St 3.0 launches. (Checked against MDA announcements on 5 October 2026; the full dated digest lives on our sister site, iso13485.my.)

Our process

1. Classification & strategy — we confirm the device class (A–D), grouping strategy (single, family, system or set) and the evidence you already hold. You get a fixed quote and a realistic timeline before committing.
2. CSDT dossier build — device description, essential principles checklist, labeling review, risk management summary and clinical evidence, compiled to CAB and MDA expectations.
3. Conformity assessment (Class B–D) — we manage the CAB submission and answer technical queries on your behalf.
4. MeDC@St submission & follow-through — application filing, MDA query handling, and handover of the registration certificate with a renewal calendar.

All-inclusive fees by device class

One number per device, everything inside: our professional work, the CAB conformity assessment fees (Class B–D) and MDA's statutory fees. Registrations are typically approved within 3 months of submission. Registrations renew every 5 years (RM6,000, all-inclusive) — see MDA renewals for the re-registration window and pricing for the full renewal schedule. Payment plans from RM1,500/month available.