Skip to main content
Medical Device Consultant.MY
MDA · Medical Device Act 2012 (Act 737)

Medical device registration with MDA — done right the first time.

Every medical device sold in Malaysia must be registered with the Medical Device Authority before it touches the market. We handle classification, technical documentation, conformity assessment and the MeDC@St submission — 100+ devices registered.

Full cost guide
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
What this covers

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.

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

Device classRisk levelAll-inclusive fee (per device)Included
Class ALow riskRM2,500Document preparation, MDA fees, MDA follow-up
Class BLow–moderate riskRM6,000CSDT preparation, CAB fees, MDA fees, follow-up
Class CModerate–high riskRM9,800CSDT preparation, CAB fees, MDA fees, follow-up
Class DHigh riskby quotationBespoke dossier scope

One number per device, everything inside: our professional work, the CAB conformity assessment fees (Class B–C) and MDA's statutory fees. 98% approval success rate; registrations typically approved within 3 months. Registrations renew every 5 years (RM6,000, all-inclusive) — see pricing for the full renewal schedule. Payment plans from RM1,500/month available.

Jawapan ringkas · Bahasa Malaysia

Berapa kos dan berapa lama pendaftaran peranti dengan MDA?

Harga kami sudah termasuk fi CAB dan fi MDA: RM2,500 (Kelas A), RM6,000 (Kelas B), RM9,800 (Kelas C) bagi setiap peranti. Kebiasaannya kelulusan diperoleh dalam tempoh 3 bulan, dengan kadar kejayaan 98%. Pelan bayaran bulanan dari RM1,500 sebulan. WhatsApp 011-2410 2070 untuk sebut harga bertulis.

FAQ

Frequently asked questions

Which class is my medical device?
Malaysia uses a rule-based classification (Class A lowest risk to Class D highest) aligned with international practice. Classification depends on intended purpose, duration of contact and invasiveness — not on what the device looks like. Classification is the first deliverable of every engagement, because it drives the fees, the evidence required and the timeline.
What is CSDT documentation?
The Common Submission Dossier Template (CSDT) is the technical dossier format MDA accepts for device registration. It covers device description, essential principles conformity, labeling, risk analysis and clinical evidence. We prepare the full CSDT for you from your existing technical files and test reports.
Do I need a CAB before MDA reviews my device?
Class B, C and D devices must pass conformity assessment by a registered Conformity Assessment Body (CAB) before the MDA application. Class A devices are exempt from CAB assessment. We prepare the dossier to CAB expectations and manage the CAB process as part of the engagement.
Can I sell while registration is in progress?
No. Placing an unregistered medical device on the Malaysian market is an offence under Act 737. Importation for demonstration or clinical evaluation has separate, narrow pathways — ask us before shipping anything.
What if my device is already CE marked or FDA cleared?
Existing CE or FDA approvals strengthen the dossier and can shorten conformity assessment, but they do not replace MDA registration. The good news: we reuse your existing technical documentation heavily, which is reflected in the timeline.

Not sure which class your device falls under?

Send us the device name and intended use on WhatsApp — a consultant will give you the likely class, the registration route and a fee estimate.

WhatsApp