Malaysia’s Medical Device Registration: A fresh look at MDA’s Verification Route

In the ever-evolving world of medical device regulation, staying ahead of the curve is crucial, especially when entering rapidly growing markets like Malaysia. The newly released Second Edition of MDA/GD/0070 from Malaysia’s Medical Device Authority (MDA) brings clarity and structure to the registration process, especially for manufacturers and authorised representatives who opt for conformity assessment by way of the verification route.

Here’s what you need to know and how to leverage it.

What’s this guidance about?

The guidance sets out the process for device manufacturers (or their authorised representatives) to submit a registration application via the online system MeDC@St under the “verification” conformity assessment route. In essence:

• It applies to device registration submissions where prior approvals/certifications from recognised jurisdictions allow a streamlined route.

• It aligns with the broader regulatory framework of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012 in Malaysia. (The MDA guidance list confirms the document exists under code MDA/GD/0070, Second Edition, 13 Oct 2025.)

• It emphasises digital submission (via MeDC@St) and introduces updated checklists and requirements.

Why it matters

For anyone marketing medical devices in Malaysia, this is important because:

• Malaysia uses a risk‐based classification (Classes A-D), which influences the depth of assessment required.

• For higher risk devices (Classes B, C, D) a full conformity assessment with a recognised Conformity Assessment Body (CAB) is typically needed. But the verification route offers a shorter pathway when a device already has strong evidence/certification from recognised markets.

• Having a more streamlined route means less time to market, less regulatory burden if you meet the eligibility.

• Digital submission via MeDC@St means more efficient tracking, less paperwork.

Key takeaways for manufacturers and authorised representatives

Here are six practical pointers to make the most of the guidance:

1. Check eligibility: Ensure your device qualifies for the verification route (for example, prior market approval in recognised jurisdictions).

2. Prepare your technical documentation: Even under verification, you’ll need a dossier aligned with MDA’s requirements (for example, the Common Submission Dossier Template) and other evidence.

3. Appoint your local agent/AR: If you’re a foreign manufacturer, you’ll need a Malaysian authorised representative to submit via MeDC@St.

4. Use MeDC@St: Understand how the online system works, submission, tracking, and correspondence.

5. Labelling and post-market commitments: Comply with local requirements, e.g., labelling (including Malaysian AR info) and adoption of post‐market surveillance obligations.

6. Plan timeline & cost: While the verification route is faster, you’ll still need to allot time for document prep, CAB review (if required), and MDA review. Having everything aligned upfront prevents surprises.

Final thoughts

The Second Edition of MDA/GD/0070 signals Malaysia’s commitment to modernising its regulatory pathways, making it more accessible for manufacturers with strong global evidence while preserving patient safety and integrity of the market. For companies looking at Southeast Asia as a growth region, Malaysia now offers a clearer and potentially quicker route, provided you tick the boxes.

If you’re navigating device registration in Malaysia, now is a good moment to revisit your strategy, update your submission checklists and ensure you’re aligned with the revised guidance.

Source:

Medical Device Authority (MDA), Ministry of Health Malaysia