On October 08, 2025, the Medical Device Division (MDD) of Hong Kong’s Department of Health released a new quick reference document titled “Overview of Hong Kong Medical Device Listing Process”. The document outlines the procedures and key considerations for submitting medical device listing applications under the Medical Device Administrative Control System (MDACS).
Scope
Introduction of a quick reference document summarizing the Hong Kong Medical Device Listing Application process under MDACS.
Key Points
1. Scope and Classification
- General Medical Devices (GMD): Classes II, III, and IV are eligible for listing; Class I is excluded.
- In Vitro Diagnostic Medical Devices (IVDMD): Classes B, C, and D are eligible; Class A is excluded.
2. Eligibility to Apply
Applicants must be:
- A local manufacturer, or
- A Local Responsible Person (LRP) designated by the manufacturer.
- The LRP must be a legal entity incorporated or registered with a business license in Hong Kong.
3. Application Procedures
- Prepare all required documentation.
- Register on the Medical Device Information System (MDIS).
- Choose one of the following application pathways:
- Pathway 1: Obtain a Conformity Assessment Certificate from a recognized Conformity Assessment Body (CAB) (“Primary Evaluation” route).
- Pathway 2: Submit marketing approval documents from recognized jurisdictions (China, US, EU, Canada, Japan, Australia, South Korea, Singapore).
- Submission review by the MDD (~12 weeks after complete submission).
- Certificate validity: 5 years.
- Application fee: Free of charge.
4. Required Documents
- Manufacturer’s designation letter for LRP
- Hong Kong Business Registration Certificate
- CAB certificate or marketing approval documents (depending on pathway)
- ISO 13485 certificate or equivalent
- Essential Principles checklist or declaration
- Clinical/Performance Evaluation Report
- Device labelling and technical documentation
- Other technical documentation
5. Renewals and Changes
- Renewals: Submit 12 weeks to 1 year before expiry.
- Changes:
- Major (affecting safety, quality, or performance): prior approval required.
- Minor: notification required.
6. Post-Market Surveillance Responsibilities (LRP)
- Handle complaints
- Report adverse events
- Manage recalls
- Maintain inspection records
References
You can access the documents here:
- (English version) Overview of Hong Kong Medical Device Listing Process
- (Chinese version) 香港醫療器械表列流程概覽
Effective Date
Immediate effect
Implications to Client
No significant impact on current listing practices. The MDD’s new quick reference serves as a useful compliance aid and enhances transparency in documentation and submission procedures.
Read the Announcement
Access the official publication here: https://www.mdd.gov.hk/en/whats-new/recent-updates/index.html.
Next Steps
If you are preparing or updating your medical device listing applications in Hong Kong, our regulatory affairs team can guide you in aligning your documentation with the latest MDACS reference materials.
Contact us at info@nordpacificmed.com or click the button below to learn more.