SOR/98-282 Medical Devices Regulations (Canada)

SOR/98-282 - 06/21 EDITION - CURRENT -- See the following: SOR/2005-142 SOR/2001-217 SOR/2002-190
Show Complete Document History


Medical Devices Regulations (Canada)

Scope

Abstract

The Canadian Medical Devices Regulations (SOR/98-282) apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro diagnostic devices.  Manufacturers selling medical devices in Canada must ensure that their medical devices meet the safety and effectiveness requirements as defined in this regulation.

Notes

Claudia's Notes:
The Canadian Medical Devices Regulations are issued under the authority of the Canadian Food and Drug Act.  Updates appear regularly, so be sure to keep an eye on this particular document if it is applicable to your business.


This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

21CFR(800-1299)
Food and Drugs

ISO-13485
Medical devices - Quality management systems - Requirements for regulatory purposes

ORDER

Price:

$28.50        




Document Number

SOR/98-282

Revision Level

06/21 EDITION

Status

Current

Publication Date

June 28, 2021

Page Count

74 pages