![iso 13485 labeling requirements iso 13485 labeling requirements](https://www.praxiom.com/iso-13485-definitions.jpg)
![iso 13485 labeling requirements iso 13485 labeling requirements](https://ps-attachments.s3.amazonaws.com/5488dbc9-7801-4082-ba1f-5fcc1e2a5c6a/tKqVEowMUgJv59qFnIZHvw.png)
Includes Both Cmdcas Recognized Registrars And Registrars That Are Directly Recognized Under Section 32.1 Of The Mdr.įor the purposes of this document, An importer is a person, Other than the Manufacturer of a medical device, Who causes the medical device to be brought into canada for sale.
![iso 13485 labeling requirements iso 13485 labeling requirements](https://slidetodoc.com/presentation_image_h/ea675422c34ff12c6784e1dba6a464b8/image-6.jpg)
Refers to sets of devices having the same or similar intended uses or commonality of technology. A list of CMDCAS recognized Registrars is on the Health Canada Website.Īny person, partnership, corporation, association, or other legal relationship which stands between the Manufacturer and the retail seller in purchases, consignments, or contracts for sale of consumer goods. Registrars that are recognized by Health Canada through the accreditation and sector qualification by the Standards Council of Canada (SCC). Certificates issued by a CMDCAS recognized Registrar will bear the SCC’s mark of accreditation.Ĭanadian Medical Devices Conformity Assessment System
#Iso 13485 labeling requirements iso
Third-party attestation related to a conformity assessment body (i.e., Registrar) conveying formal demonstration of its competence to carry out specific conformity assessment tasks (iso 17011:2004).įor the purposes of this document, a CAN/CSA-ISO 13485:03 (or ISO 13485:2003) or CAN/CSA-ISO 13485:16 (or ISO 13485:2016) quality management system certification document, issued by a Health Canada recognized Registrar to be used by a Manufacturer for obtaining, maintaining, or amending a Health Canada medical device licence.