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ISO 13485.MY
MeDC@St · MDA online submissions · Verified 4 October 2026

MeDC@St login, and the system behind it.

The MeDC@St login is at medcast.mda.gov.my — one establishment account for every MDA submission in Malaysia: licensing, device registration, change notifications and renewals. Here is how to get in, what MeDC@St 2.0 and 3.0 changed, and why submissions get queried.

Account setup & login problems
Official MDA system

Where to log in

MeDC@St is at medcast.mda.gov.my — the Medical Device Authority's own domain, and the only address for it. There is no separate “MEDCAST 2.0” or “MeDC@St 3.0” login page: the version changes behind the same door, so a 2026 bookmark still works.

Open medcast.mda.gov.myCan't get in?

The account is your company's, not yours. MeDC@St has no public browsing mode and no self-service password reset that bypasses the person responsible — which is why most “login problems” are really account ownership problems. The three common ones are below.

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

MeDC@St, MEDCAST, MedCast — same system

The official styling is MeDC@St, short for Medical Device Centralised Online Application System. Because the “@” is awkward to type, it is widely written as MEDCAST, MedCast, MEDC@ST or simply MEDC — and the site itself lives at the medcast.mda.gov.my address, which is why the spelling drifted. They all refer to the same MDA platform. There is no separate “MEDC Malaysia” system, and MeDC@St is not related to the various MEDC acronyms used by economic-development agencies elsewhere.

Access

Getting into the system: accounts and login

MeDC@St is not a public portal you browse — it is an establishment account. The login sits at medcast.mda.gov.my, and the account belongs to your company, not to an individual. Before an account is of any use you need the company itself to be real in the regulator's eyes:

  • A registered Malaysian company — SSM registration details must match exactly what you enter. Mismatches between the SSM name and the MeDC@St establishment name are a recurring source of rejections downstream.
  • A nominated person responsible — the individual MDA corresponds with. Their details drive every notification the system sends you.
  • Your quality-system certificate — GDPMD or ISO 13485, issued by a CAB. You can hold an account before this, but you cannot get a licence granted without it.

One establishment account covers every application type and can carry multiple users, so your regulatory staff and your consultant can work the same submissions without sharing a single password. Submissions can be filed from anywhere — there is no requirement to be in Malaysia to lodge them.

The login problems we are asked about most are rarely technical faults. In order of frequency: the account exists but sits under a former staff member who has left; the establishment name does not match SSM records so the account cannot be linked to the licence; or the account was created twice for one company and applications are split across both. All three are administrative, and all three are faster to fix before a deadline than during one.

We do not need your password. Consultants are normally added as users on your own establishment account, which keeps the audit trail clean and means you keep control of the account when the engagement ends.

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 4 October 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 (see the Class A–D classification rules; 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

Where do I log in to MeDC@St?
The system is at medcast.mda.gov.my. The account belongs to your establishment rather than to a person, so one company account covers establishment licensing, device registration, change notifications and renewals, and can carry several users. You need your SSM company details and a nominated person responsible to set it up, and the establishment name must match SSM records exactly or the account cannot be linked to your licence later.
Is the MeDC@St 2.0 login different from MeDC@St 3.0?
No. Both are the same login at medcast.mda.gov.my — 2.0, 2.0+ and 3.0 are versions of the platform behind it, not separate portals or separate accounts. When 3.0 modules go live for your application type during the 2026 rollout you will see the new interface after signing in as usual; your existing establishment account, users and submission history carry over. If a page invites you to log in to MeDC@St at any other domain, it is not MDA.
Is MEDCAST the same as MeDC@St?
Yes. MeDC@St is the official styling of the Medical Device Centralised Online Application System, but because the “@” is awkward to type it is commonly written MEDCAST, MedCast, MEDC@ST or MEDC. The web address itself is medcast.mda.gov.my, which is why the spelling drifted. There is only one system.
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 prices.
Do we have to give our consultant the MeDC@St password?
No, and you should not. A consultant is normally added as an additional user on your own establishment account. That keeps the audit trail attributable, satisfies the person-responsible expectation, and means you retain full control of the account when the engagement ends.

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 prices.