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MDEL [2 records]

Record 1 2025-10-02

English

Subject field(s)
  • Medical Instruments and Devices
CONT

Health Canada issues 2 different types of licences for medical devices: ... an MDEL is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.

OBS

Medical devices are grouped into 4 classes (I, II, III or IV) based on the level of potential risk related to their use. Class I medical devices (for example, manual wheelchairs) represent the lowest potential risk. Class IV medical devices (for example, pacemakers) represent the highest potential risk.

Key term(s)
  • medical device establishment license

French

Domaine(s)
  • Instruments et appareillages médicaux
CONT

Santé Canada délivre 2 types de licences d'instruments médicaux [...] Une LEIM est délivrée à des fabricants d'instruments médicaux de classe I ainsi qu'aux importateurs et aux distributeurs d'instruments de toutes les classes afin de les autoriser à importer ou à distribuer un instrument médical au Canada.

OBS

Les instruments médicaux sont divisés en 4 classes (I, II, III et IV) en fonction du niveau de risque potentiel lié à leur utilisation. Les instruments de classe I présentent le risque le moins élevé (par exemple, les fauteuils roulants), tandis que les instruments de classe IV présentent le risque potentiel le plus élevé (par exemple, les stimulateurs cardiaques).

Spanish

Save record 1

Record 2 2016-06-09

English

Subject field(s)
  • General Medicine
  • Non-Surgical Treatment
  • Special-Language Phraseology

French

Domaine(s)
  • Médecine générale
  • Traitements non chirurgicaux
  • Phraséologie des langues de spécialité

Spanish

Save record 2

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