Insights
Practical guidance on MDA registration, Establishment Licensing, GDPMD and ISO standards — written by Summayah (Maya) and updated as requirements change.
MDA Registration 9 min read
The honest answer is that device class sets the floor and your dossier quality sets everything above it. Here is what actually drives the schedule — and the four delays we see most often.
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GDPMD 8 min read
Short answer: if you import or distribute medical devices in Malaysia, you need an Establishment Licence — and GDPMD is how distribution-side businesses demonstrate the quality system behind it.
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MDA Registration 10 min read
Classification is the first decision in any registration project and the one that determines everything downstream — assessment depth, cost, and timeline. Here is how the four classes work.
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ISO Standards 8 min read
They look similar on the surface and share a common ancestor. The differences that matter are risk management, design controls, and what the standards say about improvement.
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Send it to Maya directly. Most regulatory questions can be settled in a short conversation — and there is no charge for a first assessment of where you stand.