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MyMDA Portal — Establishment Licensing

About MyMDA​

MyMDA is the Medical Device Authority's online portal for all regulatory submissions, including establishment licence applications, device registrations, and post-market reporting.

Portal URL: https://mymda.mda.gov.my

Before You Start​

Prepare the following before beginning your online application:

For All Establishment Licence Types​

  • Malaysia company registration certificate (SSM Form 9/24/49 or equivalent)
  • Company profile / business overview
  • Organisational chart showing responsible persons
  • Designated Responsible Person (RP) details — name, IC number, qualification, CV
  • Physical address evidence (tenancy agreement or utility bill)
  • Email address for official MDA correspondence (use a shared regulatory inbox, not personal email)

Additional for Manufacturers​

  • ISO 13485 certificate (current, issued by recognised certification body)
  • Site master file or abbreviated site description
  • Floor plan of manufacturing premises
  • List of devices/device categories to be manufactured

Additional for Importers/LARs​

  • Copy of LAR appointment agreement (if applicable)
  • Foreign manufacturer's ISO 13485 or equivalent quality certificate
  • List of foreign manufacturers represented

Step-by-Step Application Process​

Step 1 — Register on MyMDA​

  • Navigate to mymda.mda.gov.my
  • Click "Register" and create an account using your company email
  • Verify email address
  • Log in and complete your company profile (company name, SSM number, address, contact details)

Step 2 — Initiate a New Licence Application​

  • From the dashboard, select "Establishment Licence" → "New Application"
  • Select the licence type: Manufacturer / Importer / Distributor

Step 3 — Complete the Application Form​

  • Fill in all required fields
  • Upload all supporting documents in PDF format (max file size per document: 5 MB)
  • Ensure all documents are in English or accompanied by a certified English translation

Step 4 — Submit and Pay​

  • Review the completed application
  • Submit the application
  • Pay the application fee online (credit/debit card, FPX)
  • Retain the payment receipt and application reference number

Step 5 — Track and Respond​

  • Monitor application status via the MyMDA dashboard
  • If MDA issues a Deficiency Letter (DL), you will be notified by email
  • Respond to the DL within the stipulated timeframe (typically 60 days)
  • Upload all requested additional documents via the portal

Step 6 — Receive Licence​

  • Upon approval, MDA issues the establishment licence electronically via MyMDA
  • Download and retain the licence certificate
  • Note the licence expiry date and set a renewal reminder

Common Reasons for Deficiency Letters​

IssueTip
Expired ISO 13485 certificateAlways upload the current certificate
Missing LAR agreementEnsure agreement is signed by both parties
Incomplete organisational chartInclude all regulatory and quality roles
Mismatch between company registration and applicationUse exact legal company name
Poor quality document scansUse 300 DPI minimum for all scans

Renewal Applications​

Renewal applications should be submitted at least 60 days before expiry. The renewal process is simpler — confirm details, update changed information, upload any renewed certifications, and pay the renewal fee.

Portal Tips
  • Use Google Chrome or Mozilla Firefox for best portal compatibility
  • Save your work frequently — the portal may time out after inactivity
  • Keep PDF file sizes under 5 MB per document
  • Use the portal's message function for all official communications with MDA to maintain a record