Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices

April 16, 2018
Our file number: 18-103813-691

The above referenced proposed document was released by the International Medical Device Regulators Forum (IMDRF) for consultation and is posted on the IMDRF website for information and comment in accordance with Stage 4 of the IMDRF Standard Operating Procedure.

Please note that proposed documents are only made available in English until finalized by IMDRF. It is also important to note that amendments to proposed documents may occur as a result of regulatory consultations and subsequent deliberations within IMDRF.

All comments forwarded to Health Canada will be transmitted to IMDRF as is, with the disclaimer that they are provided for information and do not necessarily represent the views of Health Canada, except as specifically indicated in separate comments.

Comments provided to Health Canada should be submitted by May 18, 2018, in order to allow sufficient time for their assessment and subsequent transmission to IMDRF.

Comments should be directed to:

Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
11 Holland Avenue, 2nd floor
Ottawa, ON
K1A 0K9

Email: hc.device_licensing.sc@canada.ca
Telephone: 613-957-7285
Facsimile: 613-957-6345

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