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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.

One LRP may represent multiple foreign manufacturers, subject to MDD approval. The LRP must have adequate resources and governance to manage all assigned devices and maintain separate complaint and vigilance records per manufacturer.