TERMIUM Plus®

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LETTER EXEMPTION [1 record]

Record 1 2025-10-03

English

Subject field(s)
  • Medical Instruments and Devices
  • Prostheses
CONT

If the SAU [Special Access Unit] determines that the requirements of Part 2 of the regulations do not apply to the application, the applicant will be issued a letter of exemption, stating that a special access authorization is not required in order to purchase the device. An example of an exemption is when an unlicensed medical device may be sold for research use only provided they will not be used to treat, diagnose or prevent disease in patients.

Key term(s)
  • exemption letter

French

Domaine(s)
  • Instruments et appareillages médicaux
  • Prothèses
CONT

Si la SAS [Section de l'accès spécial] détermine que les exigences de la partie 2 du règlement ne s'appliquent pas à la demande, elle délivrera une lettre d'exemption au demandeur, déclarant qu'une autorisation d'accès spécial n'est pas requise pour l'achat de l'instrument. À titre d'exemple, un instrument médical non homologué peut être vendu aux fins de recherche uniquement, à la condition que l'instrument ne servira pas à traiter, à diagnostiquer ou à prévenir des maladies chez des patients.

Spanish

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