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Change Notification & Maintenance

When to Notify MDD​

Notify the MDD when any significant change affects:

  • The device itself (design, materials, intended purpose, manufacturing)
  • Labelling or IFU
  • Manufacturer name/address/ownership
  • LRP identity or details

A change is considered "significant" if it could affect: • Device safety or performance • The claimed intended purpose or clinical application • The essential design or manufacturing process (e.g., materials, sterilization method, critical dimensions) • Labelling accuracy or completeness • The identity, location, or contact details of the manufacturer or LRP • The validity of existing regulatory documentation (e.g., upcoming ISO 13485 certification expiry, new clinical evidence requirements)

Process​

  1. LRP identifies change requiring notification
  2. Prepare change notification submission via MDIS
  3. Include description of change and impact assessment
  4. MDD reviews and may accept, request additional documentation, or require re-evaluation

Changing the LRP​

  1. Coordinate between outgoing and incoming LRP
  2. Submit LRP change application via MDIS
  3. Incoming LRP assumes all post-market obligations on transfer
  4. HKMD number is typically retained for continuity