Medical Device and IVD Registration in Hong Kong: Regulatory Overview and Practical Considerations

Hong Kong operates a structured regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) through the Medical Device Administrative Control System (MDACS), managed by the Medical Device Division (MDD) of the Department of Health.

Although MDACS is currently a voluntary system, it is widely regarded as a transitional framework toward future mandatory regulation. For manufacturers planning market entry or long-term presence in Hong Kong, understanding this system is essential for building a compliant and sustainable regulatory strategy.

For official information on the MDACS framework and regulatory guidance, refer to the Hong Kong Department of Health – Medical Device Division.

Regulatory Framework for Medical Devices and IVDs in Hong Kong

MDACS establishes the administrative and technical requirements for voluntary listing of medical devices and IVDs in Hong Kong. The system defines device classification rules, documentation expectations, roles and responsibilities of economic operators, and post-market surveillance obligations.

While voluntary, MDACS listing is increasingly expected by public healthcare institutions and many private procurement channels, making it a practical prerequisite for commercial access.

Risk-Based Classification of Medical Devices and IVDs

Hong Kong applies a risk-based classification approach broadly aligned with international regulatory practices.

General Medical Devices (Class I–IV)

• Class I – Low risk

• Class II – Low to moderate risk

• Class III – Moderate to high risk

• Class IV – High risk

Higher-risk classes require a more extensive level of technical and clinical justification.

In Vitro Diagnostic Medical Devices (Class A–D)

• Class A – Low individual and public health risk

• Class B – Moderate individual risk

• Class C – High individual risk or moderate public health risk

• Class D – High individual and public health risk

Only medium- and high-risk devices are eligible for MDACS voluntary listing:

• General medical devices: Class II, III, IV

• IVDs: Class B, C, D

Classification principles are aligned with international concepts promoted by the International Medical Device Regulators Forum (IMDRF).

Voluntary Listing under MDACS: What Manufacturers Should Know

MDACS listing results in assignment of a Hong Kong Medical Device (HKMD) listing number and inclusion in the public List of Medical Devices.

Although not legally mandatory, MDACS listing:

• Facilitates acceptance by public hospitals

• Increases confidence of distributors and healthcare institutions

• Demonstrates alignment with internationally recognized safety and performance principles

Eligibility criteria and listing scope are described in MDACS guidance issued by the Medical Device Division.

Role of the Local Responsible Person (LRP)

Manufacturers without a legal presence in Hong Kong must appoint a Local Responsible Person (LRP).

The LRP acts as the local regulatory representative and is responsible for:

• Serving as primary contact with the MDD

• Submitting MDACS listing applications

• Ensuring ongoing regulatory compliance

• Managing post-market activities such as adverse event reporting and recalls

Official requirements for appointment and responsibilities of an LRP are detailed by the Medical Device Division.

Typical MDACS Listing Workflow

Device Classification

Confirm correct classification according to MDACS rules.

Appointment of LRP

Designate a qualified Hong Kong-based LRP.

Technical Documentation Preparation

Compile a technical dossier demonstrating conformity with Essential Principles of Safety and Performance, including device description, risk management, performance data, labeling, and quality system evidence.

Submission and Review

The LRP submits the application to the MDD. The authority may issue clarification requests during review.

Issuance of HKMD Listing Number

Upon acceptance, the device is assigned an HKMD number and added to the public database.

An outline of the MDACS listing procedure is available from the Endilabs.com website explaining the full prodcedure.

Post-Market Obligations in Hong Kong

After listing, manufacturers and LRPs must maintain ongoing compliance, including:

• Monitoring device performance

• Reporting adverse events

• Implementing field safety corrective actions (FSCAs) and recalls when necessary

• Notifying the MDD of significant device changes

Post-market obligations are described in MDACS post-market surveillance guidance.

How We Support Manufacturers Entering the Hong Kong Market

We support manufacturers throughout our network of professionals for the full MDACS pathway, including:

• Regulatory assessment and classification

• MDACS listing strategy

• Technical dossier review and preparation

• LRP coordination

• Post-market compliance support

Our approach focuses on building a clear regulatory roadmap that supports both initial market access and long-term compliance.

Credits: article inspired by https://www.elendilabs.com/en