From regulatory strategy and device classification to ongoing post-market support, we guide medical device and cosmetic companies through every stage of their regulatory journey.
End-to-end registration support across global markets. We handle dossier preparation, submission, and authority liaison.
Learn more →Independent Authorized Representative services with flexibility to work with different distributors in Malaysia.
Learn more →Product classification, certification, and conformity assessment to meet local and international standards.
Learn more →Ongoing compliance monitoring, incident reporting, FSCA management, and regulatory change tracking.
Learn more →We support you in identifying suitable Malaysia-based distributors who are aligned with your product category, commercial goals and distribution needs.
Learn more →Expert regulatory consultancy services to support your strategic decisions.
Learn more →Accelerating medical device and cosmetic registration pathways across Malaysia with specialized regulatory and strategic advisory expertise and being your gateway to medical device and cosmetic market access.
A clear, four-step process designed to take you from inquiry to approval with confidence.
Tell us about your products you wish to register in Malaysia. We assess regulatory pathways together.
We develop a tailored regulatory roadmap with timelines, costs, and key milestones.
Our team manages dossier preparation, submission, and authority communications.
Post-market compliance, renewals, and regulatory updates as long as you need us.
We combine deep regulatory knowledge with a personal, client-first approach to deliver results that matter.
Strategic presence in Malaysia.
One dedicated team handling your entire regulatory journey — no handoffs, no confusion.
Streamlined processes and authority relationships that accelerate approvals.
Stay informed with the latest regulatory updates, market analysis, and industry insights.
Lasers, IPL, RF and HIFU devices used in aesthetic clinics are regulated as medical devices in Malaysia, not as cosmetics. A guide for foreign manufacturers on which aesthetic equipment requires MDA registration and where the boundary sits.
In vitro diagnostic devices follow separate classification rules in Malaysia. A guide to MDA IVD registration for foreign manufacturers — the four risk classes, the seven classification rules, Authorized Representative requirements and where general device logic goes wrong.
DuoGate Regulatory Solutions is at Cosmobeauté Malaysia & beautyexpo 2026 at KLCC, 29 September – 1 October. Talk to us about NPRA cosmetic notification, Cosmetic Notification Holder services and medical device registration in Malaysia.
Talk to our regulatory experts and discover how DuoGate can accelerate your journey.
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