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ISO 13485.MY
MeDC@St · MDA online submissions · Verified 9 August 2026

MeDC@St: the system every MDA application goes through.

Licences, device registrations, change notifications — in Malaysia they all travel through MeDC@St, MDA's centralised online application system. Here is how it works, what MeDC@St 3.0 changes in 2026, and how to keep your submission out of the query loop.

Latest MDA rules
The system

What MeDC@St is

MeDC@St (Medical Device Centralised Online Application System) is the Medical Device Authority’s submission platform at medcast.mda.gov.my. One establishment account files everything:

  • Establishment licensing — the application every manufacturer, importer, distributor and authorised representative files after GDPMD / ISO 13485 certification (our packages include this)
  • Medical device registration — Class A notifications through Class D full evaluations, including the CSDT dossier upload
  • Change notification — currently under MDA/GD/0020, moving to the GD/0072 change-management regime when MeDC@St 3.0 goes live
  • Renewals — including the automated re-registration route announced 10 July 2026
History

From 2013 web forms to an AI-assisted platform

VersionWhenWhat it brought
MeDC@StJuly 2013First centralised online submissions to MDA
MeDC@St 2.0January 2019Rebuilt platform for licensing + registration, multi-user access
MeDC@St 2.0+1 February 2022Enhanced features; later gained the automated re-registration route (July 2026)
MeDC@St 3.0Rolling out Q2–Q3 2026Nine new modules — AI-assisted processing, cloud, chatbot, security, accelerated licensing and registration. Phase 1: establishment licensing, product registration, CAB applications, change management

Timeline verified 9 August 2026. The UDI guidance and the GD/0072 change-management regime are both timed to the 3.0 launch — details on the MDA latest updates page.

In practice

Where submissions actually fail

The system is the easy part; the dossier is not. In our experience across 1,000+ registrations, MeDC@St trouble is almost never technical — it is regulatory:

  • Wrong classification — the application starts in the wrong class and the whole submission restarts (classification is fully online since 1 August 2026, and we include a classification review in every registration fee)
  • CSDT gaps — missing verification data, risk analysis or clinical evidence sections for Class B–D dossiers
  • Mismatched records — names, addresses and device descriptions that differ between the manufacturer’s certificates and the application
  • Expired quality-system certificates — a lapsed GDPMD/ISO 13485 certificate silently blocks everything downstream

Every MDA query freezes your timeline until answered. Our published fees include follow-up on MDA enquiries — the query loop is our problem, not yours.

Jawapan ringkas · Bahasa Malaysia

Apa itu MeDC@St?

MeDC@St ialah sistem permohonan dalam talian MDA — semua permohonan lesen establishmen, pendaftaran peranti perubatan dan notifikasi perubahan difailkan melaluinya di medcast.mda.gov.my. Versi 3.0 sedang dilancarkan berperingkat pada 2026 dengan modul AI dan pelesenan dipercepat. Kami sediakan dan failkan permohonan anda sehingga lulus — WhatsApp 010-206 2070.

FAQ

Frequently asked questions

What is MeDC@St?
MeDC@St — the Medical Device Centralised Online Application System — is MDA’s web platform where establishments file every regulatory application in Malaysia: establishment licensing, medical device registration, change notifications and CAB-related submissions. One account covers all application types, and submissions can be made from anywhere in the world.
What is the difference between MeDC@St 2.0, 2.0+ and 3.0?
MeDC@St launched in July 2013, was upgraded to 2.0 in January 2019, and gained the 2.0+ enhancements on 1 February 2022. MeDC@St 3.0 is the ~RM20 million rebuild rolling out through 2026, adding nine modules including AI-assisted processing, cloud infrastructure, a chatbot and accelerated licensing — Phase 1 digitalises establishment licensing, product registration, CAB applications and change management.
What is the automated re-registration route?
Announced by MDA on 10 July 2026, the automated re-registration route in MeDC@St 2.0+ streamlines the 5-yearly renewal of registered devices so compliant registrations can be renewed with far less resubmission work, keeping devices in continuous supply. Whether a registration qualifies depends on its compliance history — we assess this before every renewal we handle.
Why do MeDC@St submissions get rejected or queried?
The usual causes are classification errors, incomplete CSDT sections, inconsistencies between the application and the supporting certificates (names, addresses, device descriptions must match exactly), and expired or missing quality-system certificates. Every MDA query stops your clock — our fees include preparing the dossier right and answering MDA queries until approval.
Can you file in MeDC@St on our behalf?
Yes. Filing through MeDC@St under a disciplined licence-holder’s process is exactly what our packages cover: we prepare the dossier, submit it, and handle every MDA follow-up enquiry until the licence or registration is granted — at published, all-inclusive prices.

Filing something in MeDC@St soon?

Licence application, new registration, renewal or change notification — we prepare it, file it and answer every MDA query until it is granted. Published, all-inclusive prices.