Expand Your Medical Device Business in Hong Kong with OMC Medical

Looking to enter the Hong Kong medical device market? OMC Medical supports manufacturers with complete medical device registration services under the Medical Device Administrative Control System (MDACS). Our regulatory experts help simplify the process from classification to submission and compliance support.

Our Hong Kong Regulatory Services

• Hong Kong medical device registration
• MDACS application support
• Local Responsible Person (LRP) services
• Device classification
• Technical documentation review
• IVD medical device registration
• SaMD & AI medical device support
• Post-market compliance assistance

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Hong Kong medical device regulations are managed by the Medical Device Division (MDD) under the Department of Health through the Medical Device Administrative Control System (MDACS).

MDACS is currently a voluntary listing system for many medical devices. However, hospitals, distributors, and healthcare institutions often prefer or require listed devices before market entry. As Hong Kong continues to strengthen its regulatory framework, manufacturers are increasingly choosing early registration to improve market access and commercial credibility.

OMC Medical helps manufacturers understand Hong Kong regulatory requirements and complete the registration process smoothly

What is MDACS?

The Medical Device Administrative Control System (MDACS) is Hong Kong’s framework for regulating medical devices and IVDs. The system follows international risk-based principles aligned with global regulatory practices.

MDACS covers:

• Medical device listing
• IVD device listing
• Local Responsible Person (LRP) requirements
• Post-market surveillance
• Adverse event reporting
• Importer and distributor listing

For manufacturers planning expansion into Asia, MDACS registration helps strengthen market presence and regulatory readiness.

Medical Device Classification in Hong Kong

Medical devices are classified according to risk levels.

IVD devices are classified separately into Class A, B, C, and D.

Correct device classification is one of the most important parts of the registration process. An incorrect classification can lead to delays or rejection. OMC Medical helps manufacturers determine the correct classification before submission.

Is Medical Device Registration Mandatory in Hong Kong?

Hong Kong currently operates a voluntary registration system for many medical devices under MDACS. Even though registration may not always be mandatory, many companies complete the process because hospitals, government tenders, and distributors often prefer MDACS-listed products.

Medical device registration in Hong Kong can help manufacturers:

• Improve product credibility
• Increase distributor confidence
• Support hospital procurement
• Prepare for future regulatory changes
• Strengthen market expansion plans

Local Responsible Person (LRP) Requirement

Foreign manufacturers must appoint a Local Responsible Person (LRP) in Hong Kong for MDACS submissions. The LRP acts as the official contact between the manufacturer and the Medical Device Division.

Responsibilities of the LRP

• Submission of MDACS applications
• Communication with authorities
• Technical document maintenance
• Adverse event reporting
• Post-market surveillance support

OMC Medical supports manufacturers with reliable LRP coordination and complete regulatory assistance for Hong Kong market entry.

Hong Kong Medical Device Registration Process

Step 1 – Device Classification

The first step is identifying the correct device classification according to Hong Kong medical device regulations. Classification depends on the intended use, risk level, and product type.

Step 2 – Appoint Local Responsible Person (LRP)

Foreign manufacturers must appoint a Hong Kong-based Local Responsible Person to manage submissions and communicate with the Medical Device Division.

Step 3 – Prepare Technical Documentation

Manufacturers must prepare technical documents including ISO certificates, labeling, device description, clinical evidence, and conformity information before submission.

Step 4 – MDACS Application Submission

The application is submitted through Hong Kong’s Medical Device Information System (MDIS) along with all required regulatory documents.

Step 5 – Authority Review & Queries

The Medical Device Division reviews the submission and may request additional information or clarification during the evaluation process.

Step 6 – Device Listing Approval

Once the review is completed successfully, the medical device receives MDACS listing approval for the Hong Kong market.

OMC Medical manages every stage of the process and helps reduce delays through accurate documentation and regulatory support.

Documents Required for Medical Device Registration in Hong Kong

Typical documents required include:

• Device description
• Intended use
• Risk classification rationale
• ISO 13485 certificate
• CE certificate or FDA approval (if available)
• Free Sale Certificate
• Declaration of conformity
• Labeling and IFU
• STED documentation
• Clinical evidence
• Risk management files

Well-prepared documentation plays an important role in reducing authority queries and improving approval timelines. OMC Medical reviews all documents before submission to support a smoother registration process.

Medical Device Information System (MDIS)

Hong Kong introduced the Medical Device Information System (MDIS) for online medical device submissions and compliance management.

The system supports:

• Medical device listing applications
• IVD registration
• Change notifications
• Renewal applications
• Adverse event reporting

The introduction of MDIS reflects Hong Kong’s move toward a more digital and structured medical device regulatory framework.

Why Choose OMC Medical?

1. Regulatory Expertise

Our team supports manufacturers with global medical device registration and compliance services across multiple international markets.

2. End-to-End Registration Support

We assist with classification, documentation preparation, application submission, and post-market compliance support.

3. Faster & Smoother Submission Process

Accurate documentation review helps reduce delays, deficiencies, and authority queries.

4. Global Market Experience

OMC Medical supports medical device registrations in Hong Kong, China, USA, Europe, UK, UAE, Saudi Arabia, and other international markets.

Support for Advanced Technologies

We also support:

• Software as a Medical Device (SaMD)
• AI medical devices
• IVD devices
• Diagnostic systems
• Digital health technologies

Who We Support

We work with:

• Medical device manufacturers
• IVD manufacturers
• Startups
• SaMD companies
• Importers and distributors
• Global healthcare brands

Whether you are launching a new product or expanding into the Hong Kong market, OMC Medical helps simplify the regulatory process.

Start Your Hong Kong Medical Device Registration with OMC Medical

Planning to expand your medical device business into Hong Kong?

OMC Medical provides professional support for MDACS submissions, classification, technical documentation, and Hong Kong regulatory compliance.