MyMDA Portal — Device Registration
Getting Started
All device registration applications in Malaysia are submitted through the MyMDA portal at mymda.mda.gov.my.
Prerequisites before starting a registration application:
- Valid establishment licence issued via MyMDA
- All dossier documents prepared and in PDF format
- GMDN code identified for your device
- LAR agreement in place (if foreign manufacturer)
Navigating the Portal
From the MyMDA dashboard:
- Select Device Registration from the main menu
- Choose New Application
- Select the device class (A, B, C, or D)
- The system will display the required sections and documents for that class
Document Preparation Tips
| Tip | Detail |
|---|---|
| PDF only | All uploads must be in PDF format |
| File size | Maximum 5 MB per file; compress large files with Adobe Acrobat or similar |
| Naming convention | Use descriptive names: Class-B-Technical-Summary-v1.pdf rather than document1.pdf |
| Language | All documents must be in English or with certified English translation |
| Version control | Include document version and date on each document |
| Signatures | Declarations of conformity and other signed documents must bear original or digital signatures |
Completing the Application Form
Device Identification
- Device name — use the proprietary trade name as it appears on the label
- Generic device name — GMDN preferred term or MDA-approved generic name
- GMDN code — obtain from www.gmdnagency.org if not already known
- Model/catalogue numbers — list all models covered by this application
- Intended purpose — paste the full intended use statement from your IFU
Manufacturer Details
- Enter the foreign manufacturer's details exactly as they appear on their ISO 13485 certificate
- Attach the current establishment licence of the LAR
- Attach the LAR agreement
Classification
- Select the device class
- State the applicable classification rule(s)
- If there is any classification ambiguity, explain it in the justification field
After Submission
Application Reference Number
Immediately upon submission, note your Application Reference Number (ARN). Use this in all correspondence with MDA.
Administrative Acceptance
MDA performs an initial check within ~10 working days. If documents are missing, the application may be returned for completion before the review clock starts.
Tracking Status
Monitor status via My Applications on the MyMDA dashboard. Status codes include:
- Submitted — received by MDA
- Under Review — technical review in progress
- Deficiency — query issued; action required
- Approved — DRN issued
- Rejected — application not approved (reasons provided)
Responding to Deficiency Letters
When a Deficiency Letter is issued:
- Read carefully — understand exactly what MDA is asking
- Prepare a response document addressing each point
- Upload response and supporting documents via the portal (do not email)
- Submit within the stipulated timeframe (typically 60 days)
Common Portal Issues and Solutions
| Issue | Solution |
|---|---|
| Upload failing | Reduce PDF file size; use a different browser |
| Session timeout | Save drafts frequently; work during off-peak hours |
| Cannot find GMDN code | Search at gmdnagency.org; contact MDA if device type is very novel |
| Application stuck in 'Submitted' | Contact MDA via portal messaging after 15 working days |
| Password reset | Use the self-service reset or contact MDA helpdesk |
MDA Contact
For portal technical issues: Contact the MDA helpdesk via the portal's Help section or by email at the address listed on www.mda.gov.my.
All official communication with MDA about your application should be done through the MyMDA portal's messaging function, not by email. This creates an auditable record and ensures your messages are linked to the correct application.