Medical Device Services
Comprehensive regulatory and compliance services for medical devices in Hong Kong, ensuring your products meet all MDACS requirements.
Overview
Hong Kong's Medical Device Administrative Control System (MDACS) requires careful navigation. Our medical device services team has extensive experience in device classification, registration, technical documentation, and post-market surveillance, helping you bring safe and effective devices to market 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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