Hong Kong MDCO Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Medical Device Division (MDD, formerly MDCO), under the Department of Health, Hong Kong SAR
Key Legislation:
- Medical Device Ordinance (Cap. 620) -- currently in phased implementation
- Medical Device Administrative Control System (MDACS) -- voluntary listing system, transitioning to mandatory
Classification: Risk-based, 4 classes (aligned with GHTF/IMDRF):
- Class A (low risk) | Class B (low-medium risk) | Class C (medium-high risk) | Class D (high risk)
Registration Pathway:
- Phase 1 (current): Voluntary listing under MDACS for selected high-risk devices
- Future phases: Mandatory registration expanding to cover all device classes
- Listing application submitted to MDCO
- Reference to approvals from recognized regulatory authorities (FDA, CE, TGA, Health Canada, PMDA)
- Local Responsible Person (RP) required
Key Requirements:
- MDACS listing currently voluntary (transitioning to mandatory under Medical Device Ordinance)
- Local Responsible Person required for device listing
- Recognition of approvals from major reference authorities
- Essential Principles compliance evidence
- Adverse incident reporting (voluntary framework currently)
- English and/or Chinese labeling
Current Key Guidance:
Latest Updates
No recent updates available. Please check back later.