Comprehensive Hong Kong Medical Device Listing Services
- Determine your medical device class (II, III, or IV)
- Identify the fastest and most applicable route to Hong Kong MDACS approval
- Act as your mandatory Hong Kong-based legal entity
- Manage applications, communication, and post-market surveillance
- Review and ensure all required standard documents are in place for application submission, including the Essential Principles Conformity Checklist, risk analyses, and clinical summary reports
- Verify compliance with regulatory requirements to support your application
- Leverage existing approvals from GHTF countries (USA, EU, Canada, Japan, Australia), China, or Singapore, where applicable, to accelerate your timeline
- Navigate the GBA Connect Scheme enabling HK-listed devices to be used in 70+ designated hospitals in China
- Manage 5-year MDACS renewals
- Maintain list of importers, distributors and supply records of devices imported for inspection
- Relay product-related complaints to the manufacturer for investigation, and support implementation of corrective and preventive actions
The Cisema Advantage: Accelerate Your Hong Kong Market Access
Proven Hong Kong regulatory expertise
Direct advocacy with the MDD
Experience with advanced and high-risk technologies
Strategic focus on China market expansion via Hong Kong:
The Path to Hong Kong Medical Device Market Entry
Document Collection and Verification
Collect, verify, and submit the required documents and information in accordance with MDACS listing requirements
LRP Appointment
Appoint Cisema as your licensed Local Responsible Person (LRP), acting as your legal representative for all MDACS submissions and regulatory communications
Submission & Advocacy
Our team manages the entire submission process through the Hong Kong MDIS online portal and handles all follow-up interactions with the MDD. We proactively respond to supplementary notices to maintain momentum and reduce delays.
Launch
Once the listing is granted, deploy your MDACS listing number to support eligibility for public hospital procurement and tender participation.
Renewal
Cisema manages the required five-year renewal process, ensuring ongoing regulatory compliance and uninterrupted market access for your medical device.
Hong Kong Medical Device Listing FAQs
What are the advantages of medical device registration in Hong Kong?
Registering your medical device in Hong Kong offers significant strategic and commercial benefits:
- Access to Public Healthcare Contracts in Hong Kong – Starting March 23, 2026, all applicable medical devices (AMDs) procured by Hong Kong’s Department of Health must be listed under MDACS without exception. Registration opens the door to a major, high-value segment of Hong Kong’s healthcare market, which would otherwise be inaccessible.
- Gateway to the Greater Bay Area (GBA) and Mainland China – Medical devices procured or used in Hong Kong public hospitals are recognized for emergency or urgent deployment under GBA initiatives, allowing international companies to enter southern China faster, without immediately going through the full NMPA approval process. This reduces time-to-market for your device across the region.
- Affluent and Aging Population – Hong Kong has one of the world’s wealthiest and fastest-aging populations, driving high demand for advanced medical devices, chronic disease management solutions, and healthcare services. Registration lets international companies tap into this lucrative demographic
- Regulatory Risk Mitigation with Local Support – Having a Hong Kong Local Responsible Person (LRP) ensures continuous oversight, adverse event reporting, and compliance with local guidance (TR-004), reducing delays or market entry risks in the region.
- Strategic Regional Hub – Hong Kong is an international business and logistics hub. Registration allows your company to use Hong Kong as a base for marketing, sales, and supply to the wider Asia-Pacific region, leveraging the city’s legal stability, international business environment, and favorable IP protection.
At Cisema, we help international companies turn Hong Kong registration into a commercial advantage, unlocking public tenders, regional distribution opportunities, GBA access, and enhanced credibility to grow your device business in Asia.
Is medical device listing in Hong Kong voluntary?
Technically, Medical Device Administrative Control System (MDACS) listing is voluntary, but for public procurement, it is essential.
As of November 1, 2024, all procurement by Hong Kong’s Department of Health (DH) require a valid MDACS listing number. Without it, even innovative or clinically valuable devices are excluded from the public sector market.
Cisema bridges the gap between regulatory compliance and market access, ensuring your Hong Kong medical device meets all MDACS requirements so you can unlock public tender eligibility, GBA access, and faster market entry.
How long does the Hong Kong medical device listing process take?
The official review timeline for MDACS registration is 12 weeks. However, incomplete or poorly prepared submissions can extend this to 24 months or more. Our focus is a right-first-time submission.
What is the GBA Connect scheme?
The GBA Connect scheme allows Hong Kong-listed medical devices that are urgently needed for clinical use to be deployed in designated Greater Bay Area hospitals, without requiring full China NMPA registration. This fast-track route helps medical devices reach patients in need more quickly while leveraging Hong Kong regulatory approval as a bridgehead.
