CANADA MEDICAL DEVICES REGULATIONS - CMDCAS
Health
Canada requires medical device manufacturers to use a quality system
certificate as evidence of compliance to the appropriate regulatory
quality
system requirement. Health Canada will only accept quality system
certificates
that have been issued by special third party auditing organizations
called
Canadian Medical Devices Conformity Assessment System (CMDCAS)
recognized
registrars. The Medical Devices Regulations do not require importers or
distributors of medical devices to have a registered quality system.
The
Medical Devices Regulations require class II, III and IV medical
devices to be
manufactured (class II) or designed and manufactured (class III
& IV) under
CAN/CSA ISO 13485:2003. There are no regulatory quality system
requirements for
Class I medical devices. These quality system requirements came into
force on
January 1, 2003.
Establishment licence and
Problem reporting
Any person who imports into
Canada, or sells in Canada, a medical device for
human use requires an establishment licence. Mandatory and Voluntary
Problem
Reporting for Medical Devices are strictly regulated.
Labelling
Regulations state that no person shall
import or sell a medical device unless the labelling of the device
bears the
information described in that section. In order to comply with the
Regulations,
it is sufficient that a licence holder has a procedure in place to
ensure
compliance with this labelling requirement for the medical devices they
import
or sell. Class I medical devices do not require licensing but
must comply with
the labelling requirements | 
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