Class A medical device registration in Malaysia.
Class A skips the Conformity Assessment Body and goes straight to MDA through MeDC@St. It is still a full registration: the manufacturer’s QMS certificate, a Malaysian-compliant label and a Declaration of Conformity are required, and MDA’s fees rose to RM1,250 per device on 1 January 2026.
Class A versus Classes B–D.
| Class A | Class B, C, D | |
|---|---|---|
| Risk | Low | Low-moderate to high |
| CAB conformity assessment | Exempt (Exemption Order 2024, para 5) | Required before the MDA application |
| Submitted | Directly to MDA in MeDC@St | To MDA in MeDC@St after CAB assessment (or verification) |
| Technical documentation | Form sections + Declaration of Conformity | Full CSDT dossier |
| MDA fees (2026) | RM500 + RM750 = RM1,250 | B RM1,250 · C RM2,500 · D RM3,750 |
| Our all-in fee | RM3,800 per device | B RM6,800 · C RM9,800 · D RM12,000 |
| Validity | 5 years; re-registration opens 1 year before expiry | |
The gap between our Class A and Class B fees is mostly the CAB fee, which Class A does not pay. Full fee breakdown: registration cost guide.
The 2026 fee change
The Medical Device (Amendment) Regulations 2025 (P.U. (A) 330, gazetted 11 September 2025) amended the Fifth Schedule from 1 January 2026:
- Class A application fee: RM100 → RM500.
- Class A registration fee: none → RM750.
Classes B to D were not changed. Older guides quoting a RM100 Class A cost are out of date. Our all-in Class A fee already includes the new MDA fees.
Who submits
The applicant must hold a valid MDA establishment licence as a local manufacturer or authorised representative; MeDC@St pre-fills the licence number and expiry. A foreign manufacturer needs a Malaysian authorized representative to hold its Class A registrations. Distributors and importers need their own establishment licences to deal in the device, but they do not file the registration.
What the application contains
MDA's submission guide for Class A sets out ten sections of the MeDC@St form. For a first registration:
| # | Section | What MDA expects |
|---|---|---|
| 1 | Classification | Class and rule under the First Schedule (MDA/GD/0009; MDA/GD/0001 for IVDs) |
| 2 | Is it a medical device? | Device, accessory or component under section 2 of Act 737 |
| 3 | General information | Name, brand, category, description, intended use, HS/GMDN/UDI codes, IFU |
| 4 | Grouping | Device list under MDA/GD/0005 (or MDA/GD/0054 for IVDs), with identifiers |
| 5 | Additional requirements | Only if applicable: sterile, measuring function, active device, biological-origin materials |
| 6 | Manufacturer | Legal manufacturer, manufacturing sites and the QMS certificate |
| 7 | Pre-market approvals | Optional but advisable: FDA, TGA, EU, Health Canada, Japan |
| 8 | Labelling | Sixth Schedule of MDR 2012 and MDA/GD/0026 |
| 9 | Post-market surveillance | Adverse events, field safety corrective actions and recalls for the past 3–5 years, or an attestation of none |
| 10 | Declaration of Conformity | Signed by the manufacturer |
The QMS certificate: yes, even for Class A
Section 6 asks for the manufacturer's quality management system certificate, with a scope that covers the device: ISO 13485, or MDSAP, US FDA QMSR or Japan MHLW Ordinance 169. ISO 9001 is accepted only for Class A empty gas cylinders. If the legal manufacturer is not ISO 13485 certified, the OEM's certificate can be used with MDA's traceability template. No CAB assessment does not mean no QMS. Local manufacturers without a certificate start with ISO 13485.
Sterile, measuring and active Class A devices
- Supplied sterile: sterilisation validation (bioburden, pyrogen, sterilant residues where relevant, packaging validation), evidence of revalidation and a post-sterilisation functional test.
- Measuring function where inaccuracy could significantly harm the patient: studies showing conformity with metrological requirements.
- Active devices: electrical safety and EMC evidence, typically to the IEC 60601-1 series.
Labelling
The label follows the Sixth Schedule of the Medical Device Regulations 2012 and MDA/GD/0026: device name and identifier, brand, manufacturer and AR name and address, lot or serial number, expiry or manufacturing date, storage and shelf life, the MDA registration number once issued, and a Bahasa Malaysia translation for home-use and self-test devices.
After registration
- Five-year validity. Re-registration opens exactly one year before expiry and needs an updated QMS certificate, label, PMS data and DoC. Miss the expiry and the certificate is deactivated: see MDA renewals.
- Changes to the device or its registered information go through a change notification before they are made.
- Advertising to the public still needs MDA approval, even for Class A: see advertisement approval.
Berapakah fi pendaftaran peranti perubatan Kelas A pada 2026?
Sejak 1 Januari 2026 (P.U. (A) 330/2025), fi permohonan Kelas A ialah RM500 dan fi pendaftaran RM750, iaitu RM1,250 setiap peranti. Kelas A dikecualikan daripada penilaian pematuhan oleh CAB dan dihantar terus kepada MDA melalui MeDC@St, tetapi sijil sistem pengurusan kualiti pengilang (contohnya ISO 13485) tetap diperlukan. Yuran penuh kami RM3,800 setiap peranti. WhatsApp 010-206 2070.
Frequently asked questions
Does a Class A medical device need to be registered in Malaysia?
How much are the MDA fees for Class A in 2026?
Who can submit a Class A registration?
Does a Class A device need ISO 13485?
Do sterile or measuring Class A devices need more?
How long is a Class A registration valid?
How do we know the device really is Class A?
Registering Class A devices?
Send us the product list, labels and the manufacturer’s QMS certificate. We will confirm the class, group the devices to keep fees down, and file directly with MDA.