New Enforcement by MDA: Import Permit Requirement for Medical Devices

The Medical Device Authority (MDA) has announced a significant regulatory update that will impact all medical device importers and related stakeholders in Malaysia. Starting 2 January 2026, the importation of medical devices will officially require an Import Permit (IP) under the Customs (Prohibition of Import) Order 2023.

This new enforcement marks an important step towards strengthening regulatory oversight and ensuring that all medical devices entering Malaysia comply with national safety and quality standards.

🔍 What’s Changing

Under this new regulation, importers will now be required to apply for an Import Permit through the ePermit system — an online platform introduced to streamline the submission and verification process for permit applications.

Here are the key points you need to know:

✅ ePermit System Implementation
All import permit applications must be submitted via the new ePermit platform. This system aims to simplify compliance and improve traceability of imported medical devices.

✅ Permit Application Timeline
Importers must submit their Import Permit applications at least seven (7) days before shipment to avoid any delays at customs.

✅ Processing Time
The MDA will process applications within three (3) working days, or within 24 hours for urgent or temperature-sensitive shipments, such as vaccines or medical diagnostics.

✅ Mandatory Implementation Date
The Import Permit requirement becomes mandatory effective 2 January 2026. After this date, shipments without valid permits may be delayed or denied entry.

✅ Transition Period Fee Waiver
To help ease the transition, the MDA is offering a 9-month processing fee waiver (up to RM130) for eligible importers. This initiative encourages early adoption and familiarization with the new system before the enforcement date.

🧭 Why This Matters

This new policy strengthens Malaysia’s commitment to ensuring patient safety, product traceability, and regulatory compliance in the medical device industry. Importers, distributors, and regulatory consultants will need to review and adjust their internal procedures to align with the new requirements.

Failure to comply may result in shipment delays, additional costs, or even product recalls — making early preparation crucial for all parties involved in the medical device supply chain.

💼 How AnsarComp Can Help

At AnsarComp, we understand that adapting to new regulatory frameworks can be challenging. Our consultants are ready to support you throughout every stage of the transition — from system registration and permit submission to compliance advisory and documentation review.

We can help ensure your company remains fully compliant with the latest MDA regulations and continues importing medical devices without disruption.

👉 Whether you’re an importer, distributor, or consultant assisting clients in the medical device sector, now is the time to prepare.
Let’s make the transition smoother, faster, and fully compliant — together.