Registration Overview
Registration Requirement
Under Section 14 of the Medical Device Act 2012 (Act 737), no person shall supply a medical device in Malaysia unless the device is registered with MDA and has been assigned a Device Registration Number (DRN).
This applies to all medical devices supplied commercially in Malaysia — whether manufactured locally or imported.
Who Must Register?
| Entity | Obligation |
|---|---|
| Malaysian manufacturer | Must register devices before supply |
| Foreign manufacturer (via LAR) | LAR registers devices on manufacturer's behalf |
| Importer | Must verify device has valid DRN before import/supply |
| Distributor | Must verify device has valid DRN before distribution |
The device registration is linked to the establishment licence of the manufacturer or LAR. If the establishment licence lapses, the device registration is at risk.
Exemptions from Registration
The following categories are exempt from registration requirements:
| Exemption | Conditions |
|---|---|
| Custom-made devices | Made for a specific individual patient; specific statement required |
| Devices for clinical investigation | Must follow MDA's clinical investigation pathway |
| Devices imported for personal use | Non-commercial, personal use only |
| Devices in transit | Not for supply in Malaysia |
| Unregistered devices — Special Access Route | Approved by MDA under specific criteria |
Registration Validity
All device registrations are valid for 5 years from the date of approval. Renewal must be applied for before expiry.
Device Registration Number (DRN)
Upon successful registration, MDA assigns a Device Registration Number (DRN):
- The DRN must appear on the device label and/or packaging as required
- The DRN is specific to the registered device, manufacturer, and LAR
- Transfer of DRN to a new LAR requires a formal variation application
Registration Routes by Class
| Class | Route | Key Differentiator |
|---|---|---|
| A | Notification / self-declaration | No independent CA body review |
| B | Full registration | QMS + technical file |
| C | Full registration | Enhanced technical file + clinical evidence |
| D | Full registration | Full design dossier + clinical data + third-party review |
The MyMDA Registration Portal
All registration applications are submitted via the MyMDA portal. See MyMDA Portal — Registration for a practical walkthrough.
ASEAN Common Submission Dossier Template (CSDT)
Malaysia has adopted the ASEAN CSDT as an accepted dossier format. If you are registering in multiple ASEAN markets simultaneously or sequentially, preparing your dossier in CSDT format reduces the effort required for adaptation. See ASEAN Harmonisation.
For complex, novel, or borderline devices, MDA offers pre-submission meetings. These can clarify dossier requirements, classification, and expected clinical evidence before you commit significant resources to dossier preparation.