Class D Registration Guides

Available routes for Class D

Route	Conditions
Full	No prior approval from any overseas reference agency
Abridged	Approval from ≥1 overseas reference agency
EDR	≥2 overseas reference agency approvals + no prior rejection/withdrawal

EDR exclusions — the following cannot use EDR (Full or Abridged only):

• Active implantable devices (pacemakers, neurostimulators, cochlear implants)
• Implantable devices in direct contact with the central circulatory system or CNS
• Hip, knee, and shoulder joint replacements (bioactive implants)
• Devices with a registrable drug in a secondary role
• IVD assays for HIV testing and blood/tissue donor compatibility testing

HSA registration guides for Class D

• Class D Full Registration Guide
• Class D Abridged Registration Guide
• Class D Expedited Registration (EDR) Guide
• Class D with registrable drug (Full)
• Class D with registrable drug (Abridged)

Official sources

• HSA: Class D registration guides
• HSA: Fees and turnaround time