International Market Access.
Medical Device Market Access in Hong Kong
Overview of Hong Kong's Medical Device Regulatory Framework
Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD), is a voluntary listing framework. Listing supports market access and preparation for future regulatory developments.
Specialist regulatory support can help manufacturers understand Hong Kong's requirements and manage market entry efficiently.
The Regulatory Framework
MDACS listing is widely used, including in healthcare procurement. It covers Class II–IV general medical devices and Class B–D IVDs, with a risk-based approach aligned with international medical device regulatory principles.
Risk-Based Device Classification
Device risk determines the regulatory pathway and supporting documentation required for listing.
- General medical devices: Class I (lowest risk, such as simple bandages) to Class IV (highest risk, such as pacemakers).
- IVDs: Class A (lowest risk) to Class D (highest risk, such as HIV tests).
Manufacturers should establish the correct classification at the outset, as it determines the applicable listing requirements.
Local Responsible Person (LRP)
Overseas manufacturers seeking listing need a Local Responsible Person (LRP) in Hong Kong. The LRP's responsibilities include:
- Acting as the contact point with the MDD.
- Managing the device listing application.
- Maintaining compliance with MDACS requirements after listing.
- Managing adverse incident reporting, recalls and field safety corrective actions (FSCAs).
- Maintaining required regulatory documents and records in Hong Kong.
Experienced LRP service providers can support local regulatory communication and the management of post-market obligations.
Listing Process
Key stages typically include:
- Regulatory strategy and classification: Confirm the device's classification and plan the applicable market access pathway.
- Dossier preparation and localisation: Assemble technical documentation, including STED, and check applicable Hong Kong labelling, language and format requirements.
- Submission: The LRP submits the application to MDD, manages regulatory communication and responds to review questions.
- Post-market compliance: Continue surveillance, incident reporting, recalls and notifications of changes to listed devices.
MDACS may recognise authorisations from specified reference jurisdictions. Thorough dossier preparation and appropriate local representation remain important for timely market access and ongoing compliance.
Author: Elendilabs · 23 June 2025
Original article: View original