How long MDA registration takes, step by step.
Most published timelines for Malaysia are guesses. These are MDA’s own figures, step by step, from licence to registration, and the two response deadlines that decide whether your application survives a query.
The timeline, step by step.
| Step | Who | Official time | Source |
|---|---|---|---|
| Establishment licence (if you do not hold one) | MDA | 14–21 working days for a complete application | MDA announcement, 25 Mar 2024 |
| CSDT dossier or Class A form | You / us | Depends on your documents | — |
| CAB conformity assessment (Classes B–D, verification) | CAB | About 1.5 months, excluding your response time | MDA/GD/0068 §5; MDA/GD/0070 Annex 2 |
| MDA review, Class A | MDA | 14–20 working days | MDA/GD/0070 §6.4 |
| MDA review, Classes B–D (verification route) | MDA | 30 working days | MDA/GD/0070 §6.4 |
| MDA review, full conformity assessment | MDA | 30 days (Class A), 60 days (Classes B–D) | MDA re-registration FAQ |
MDA’s review clock runs from a complete submission with cleared payment. Neither Act 737 nor the Medical Device Regulations 2012 set a deadline for MDA’s decision.
Our track record
Registrations we manage are typically approved within about 3 months of submission in MeDC@St. The time before submission is mostly in your hands: how quickly the manufacturer supplies the QMS certificate, test reports, labels and post-market data. A gap analysis at the start gives a realistic date before you commit.
The two deadlines that end applications
- 30 working days to supply missing mandatory information. Miss it and the application is withdrawn and the fee is not refunded (in force since 1 April 2023). This applies to new registrations, re-registrations and change notifications.
- 90 working days from MDA’s request for other additional information or samples (MDA/GD/0070 §6.2–6.3).
Most delays we see come from queries the applicant cannot answer quickly because the manufacturer abroad has to supply the evidence. Collecting it before submission is the single biggest time saver.
Faster routes
| Route | Published time |
|---|---|
| Singapore HSA reliance (Classes B–D, permanent from 1 Mar 2026) | CAB review 30 working days (vs 60 for full assessment); MDA registration within 30 working days |
| Chinese IVDs on the verification pathway | 30 working days (MDA press release, July 2025) |
| WHO Collaborative Registration Procedure (prequalified IVDs, from 3 Feb 2026) | MDA aims for 90 working days after full WHO access and a complete application |
| Thai FDA reliance (permanent from 1 May 2026) | No timeline published |
Re-registration
MDA gives an initial response within 14 working days of a re-registration being assigned to a reviewer. The Automated Re-Registration Route (from 13 July 2026) has no prescribed review timeline. The window opens one year before expiry, and an expired certificate cannot be re-registered: see MDA renewals.
Berapa lama pendaftaran peranti perubatan MDA?
Bagi laluan verifikasi, MDA menyemak permohonan dalam 14–20 hari bekerja (Kelas A) dan 30 hari bekerja (Kelas B, C, D) selepas dokumen lengkap dan bayaran dijelaskan (MDA/GD/0070). Penilaian CAB mengambil kira-kira 1.5 bulan. Lesen establismen diproses dalam 14–21 hari bekerja. Maklumat wajib yang tertinggal mesti dikemukakan dalam 30 hari bekerja. WhatsApp 010-206 2070.
Frequently asked questions
How long does MDA take to review a registration application?
How long does the whole registration take from start to approval?
How long does an MDA establishment licence take?
What happens if we do not answer MDA’s query in time?
Is the Singapore HSA route faster?
How long does re-registration take?
Need a launch date you can plan around?
Send the device list, class and what the manufacturer can supply. We will map each step against MDA’s published times and give you a date before you commit.