Authorised Representative in Malaysia

Secure Your Malaysian Market Entry with Complete Commercial Freedom. Appoint Warda Consulting Services as your Independent Authorised Representative (AR). We protect your intellectual property, ensure total compliance with MDA regulations, and keep you in control of your distribution strategy.

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Under the Malaysia Medical Device Act 737, foreign manufacturers cannot register their devices directly with the Medical Device Authority (MDA). You must appoint a local entity to act as your official Authorised Representative. Many foreign manufacturers make the critical mistake of appointing their local distributor as their AR. This creates a severe lock-in effect:
Your commercial partner now holds your regulatory approvals.
Your highly sensitive technical files and IP are exposed to a sales organization.
If the distributor underperforms, changing partners means starting the lengthy registration process all over again.
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There is a better, safer way.

At Warda Consulting Services, we do not sell medical devices. We protect the companies that make them. By acting as your 100% Independent AR, we separate your regulatory compliance from your commercial sales, giving your enterprise absolute control.
Ultimate Commercial Freedom

Your product registrations belong to you, not your distributors. By using Warda as your independent AR, you are free to appoint multiple distributors, scale your sales network, or switch underperforming commercial partners without ever risking your market access or restarting the MDA approval process.
Ironclad IP Protection

Your technical documentation, design dossiers, and trade secrets are the lifeblood of your enterprise. As a specialized regulatory consultancy holding GDPMD certification, we maintain strict, enterprise-grade confidentiality. Your IP stays with regulatory experts, safely away from local commercial supply chains.
End-to-End Regulatory Lifecycle Management

We are not just a mailbox for your MDA correspondence. We are your proactive regulatory shield in Southeast Asia. Our enterprise packages include:
Pre-market assessment and device classification.
Seamless CSDT (Common Submission Dossier Template) preparation and submission.
Post-market surveillance, adverse event reporting, and field safety corrective actions (FSCA).
Liaising directly with the Malaysian Medical Device Authority (MDA) on your behalf.