Medical Devices and Cosmetics Registration
End-to-end regulatory registration support for medical devices and cosmetics in Malaysia. From classification to approval, we handle every step with expertise and precision.
Service Highlights
Streamlined Registration, Faster Market Access
Navigating medical device and cosmetics registration across multiple jurisdictions can be complex, time-consuming, and risky. At DuoGate, we transform this complexity into a smooth, streamlined process.
Our experienced regulatory affairs specialists handle every aspect of the registration journey — from initial product classification and dossier preparation to authority submission and final approval. We work as an extension of your team, providing transparent communication and proactive issue resolution at every stage.
Whether you're entering a single market or planning a multi-country rollout, our tailored approach ensures the most efficient path to compliance.
Key Service Features
Everything you need for a successful medical device and cosmetics registration in one comprehensive service package.
Strategic Classification
Expert device classification according to local regulatory frameworks, ensuring the correct registration pathway from day one.
Complete Dossier Preparation
Full technical documentation preparation including CSDT, technical files, declarations, and supporting evidence.
Authority Liaison
Direct communication with regulatory authorities, handling queries and clarifications throughout the review process.
Fast-Track Pathways
Leverage reference agency approvals (FDA, CE, TGA) to access expedited registration routes where available.
Real-Time Tracking
Stay informed with regular status updates, milestone reports, and transparent progress tracking.
Renewal Management
Proactive renewal management ensures your registrations remain valid without interruption to market access.
Our Registration Process
A clear, structured approach designed to minimize delays and ensure successful registration outcomes.
Initial Assessment & Classification
We analyze your product specifications, intended use, and target markets to determine the correct device classification and identify the optimal registration pathway.
⏱ 1-2 weeksGap Analysis & Strategy Development
Comprehensive review of your existing technical documentation against local requirements. We develop a detailed regulatory strategy with timelines and milestones.
⏱ 2-3 weeksDossier Preparation
Our team prepares all required documentation including the Common Submission Dossier Template (CSDT), Declaration of Conformity, technical files, and supporting evidence.
⏱ 4-6 weeksAuthority Submission
Formal submission to the relevant regulatory authority through official channels. We handle all administrative requirements and fee payments.
⏱ 1 weekReview & Response Management
Active monitoring of the review process. We respond promptly to authority queries, clarification requests, and additional information requirements.
⏱ 8-16 weeksApproval & Post-Approval Support
Upon approval, we deliver your registration certificate and provide ongoing support for renewals, variations, and post-market obligations.
⏱ OngoingAll Device Classes Supported
We handle the full spectrum of medical device classifications, from low-risk consumables to complex high-risk devices.
Class A
Bandages, examination gloves, simple diagnostic tools, non-sterile instruments
Class B
Hypodermic needles, suction equipment, hearing aids, ultrasound diagnostic equipment
Class C
Lung ventilators, surgical lasers, infusion pumps, anesthesia equipment
Class D
Heart valves, implantable defibrillators, total joint replacements, life support systems
Service Deliverables
A comprehensive package of services and documentation designed to ensure successful registration outcomes.
Classification Report
Detailed device classification analysis with regulatory pathway recommendation
Regulatory Strategy Document
Customized roadmap with timelines, milestones, and risk mitigation plans
Complete Dossier Package
Full technical documentation prepared to local regulatory standards
Submission Confirmation
Official acknowledgment from regulatory authorities upon submission
Progress Reports
Regular updates on submission status and review milestones
Registration Certificate
Official approval documentation upon successful registration
Post-Approval Support
Ongoing guidance for renewals, variations, and compliance obligations
Dedicated Account Manager
Single point of contact throughout the entire registration journey
Related Services
Complementary services that work together to provide comprehensive regulatory support.
