Your Trusted Partner in
Medical Device Approval
Navigating Malaysia’s Medical Device Authority (MDA) requirements can be complex—but with our regulatory expertise, it doesn’t have to be. We provide end-to-end solutions for medical device registration under the Medical Device Act 2012, including product classification, conformity assessment, and submission to the MDA. Our streamlined process accelerates your time to market while ensuring full compliance with local regulations.
Company Overview
Founded in 2013 and headquartered in Setia Alam, Selangor Darul Ehsan, Rocky Scientific Instrumentation has established itself as a trusted leader in regulatory consultancy and quality management services. Specializing in the medical device and pharmaceutical industries, our mission is to streamline the regulatory submission process and ensure compliance, so our clients can focus on growing their business.
End-to-End Regulatory Support
Deep Knowledge of ASEAN & NPRA Guidelines
Fast-Track Market Entry
Our Products
At AksesCare, we provide a wide range of industry-standard pharmaceuticals, medical equipment and diagnostic solutions.
End-to-End Compliance Management
At Rocky Scientific Instrumentation, we take a strategic and client-focused approach to regulatory compliance. By combining deep industry expertise with a commitment to excellence, we simplify complex regulatory processes, allowing businesses to focus on innovation and growth.
Why Choose Us?
Phone: +60193878020