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Who Needs to Comply?

Manufacturers​

Foreign manufacturers cannot submit MDACS listing applications directly — all applications must be submitted through an appointed Local Responsible Person (LRP).

Local Responsible Person (LRP)​

The LRP is a Hong Kong-based entity that:

  • Submits and manages the MDACS listing application via MDIS
  • Holds the HKMD listing number
  • Is responsible for post-market vigilance (adverse event reporting, FSCAs)
  • Maintains complaint handling records
  • Tracks devices to user level for specified device types
  • Notifies MDD of significant changes

Any Hong Kong-registered company can serve as LRP — commonly the HK distributor, a regulatory service provider, or a local subsidiary. See LRP Role & Obligations.

Importers & Distributors​

Importers/distributors are incentivised to source only MDACS-listed devices (for Classes II–IV / IVD B–D) to satisfy procurement and hospital requirements.

Healthcare Facilities​

Public hospitals must procure MDACS-listed AMDs under Stage C. Private facilities commonly impose equivalent standards.