Medical Device Services
Medical device regulatory consultants for MDACS, international registrations, and medical device market entry in Hong Kong and Asia.
Overview
Whether you need an experienced medical device regulatory consultant or a practical path for Asia market entry, we help you navigate Hong Kong's Medical Device Administrative Control System (MDACS): device classification, registration, technical documentation, Local Responsible Person support, and post-market surveillance—so you can commercialize safely and efficiently.
Key Features
Device classification and registration
Technical documentation preparation
Quality management system implementation
Post-market surveillance support
Key Benefits
Expert MDACS navigation
Streamlined registration process
Reduced time-to-market
Ongoing compliance support
Registration Process
Device classification assessment
Technical file preparation
Local Responsible Person appointment
MDIS submission and follow-up
Post-market surveillance setup
Ideal For
- Medical device manufacturers
- International device importers
- Companies needing LRP services
- Organizations updating device registrations
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