Snapshot

The Hong Kong GBA Urgent-Use Fast-Track Pathway via the Medical Device Administrative Control System (MDACS pathway has been developed by the of Hong Kong.

This pathway can be used where Applies to Class II, III, and IV medical devices; plus Class B, C, and D (high risk) IVDs. Must be procured, listed, and actively used by public hospitals managed by the Hong Kong Hospital Authority..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Canada Europe United States

Target time assessment is Target Time: ~98 Calendar Days (Class IIb) / ~140 Calendar Days (Class III) - Target review periods at 70 working days for Class IIb devices and 100 working days for Class III devices (approximately 98 to 140 calendar days) Target Timing Range: Selected Range: 91–120 (Class IIb) / 121–150 (Class III).