Longer explanations than a service page has room for — the certification process end to end, the law it rests on, and who is allowed to hold what. No theory we have not used on a live submission.
What ISO 13485:2016 certification actually involves in Malaysia — who needs it, the seven stages from gap analysis to certificate, how long each takes, what it costs, and how it connects to your MDA establishment licence.
· 11 min read
Malaysia regulates medical devices through two 2012 Acts and four sets of regulations. What Act 737 and Act 738 actually say, which duties fall on which establishment, and the sections MDA enforces in practice.
· 10 min read
A foreign manufacturer cannot register a device in Malaysia directly. Who the registration holder must be, what an authorised representative is liable for, how the four establishment roles differ, and what each one costs.
· 9 min read
These articles explain the reasoning. The pages below give you the answer and the price without the argument:
Tell us what you make or import and which market you are entering. We will map the approvals you need, in the order you need them, and quote a fixed price.