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Named-Patient Access

Overview​

Named-patient access allows a specific identified patient to import and use a medical device not registered on the Swiss market, where the device is needed for that patient's treatment and no Swiss-registered equivalent is available. Legal basis: TPA Art. 36.

How It Differs from Compassionate Use​

  • Named-patient (TPA Art. 36): primarily an import authorisation for a specific device for a specific patient; covers import from abroad
  • Compassionate use (TPA Art. 9 para. 4): broader use of unregistered devices not limited to import; may include devices in development

Application Process​

  1. Treating physician (or importer/CH REP on their behalf) submits application to Swissmedic
  2. Application includes: anonymised patient identification; diagnosis and clinical need; device description; country of origin and regulatory status; confirmation no Swiss-registered equivalent is available
  3. Swissmedic reviews and may grant a device-specific, patient-specific authorisation
  4. Device is imported following authorisation

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.