(2) An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:
(a) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;
(b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;
(c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;
(d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;
(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and
(f) a copy of a quality system certificate certifying that the quality system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13488-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002, as amended from time to time.
http://laws.justice.gc.ca/en/f-27/sor-9 ... 26098.html
So the device is safe to use, but its not licensed for hair treatment, what do you think folks, shall I wait the US FDA approval before wasting any money ?
--------------------------
Tricomin
Revivogen
Apple Vinegar
(a) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;
(b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;
(c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;
(d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;
(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and
(f) a copy of a quality system certificate certifying that the quality system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13488-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002, as amended from time to time.
http://laws.justice.gc.ca/en/f-27/sor-9 ... 26098.html
So the device is safe to use, but its not licensed for hair treatment, what do you think folks, shall I wait the US FDA approval before wasting any money ?
--------------------------
Tricomin
Revivogen
Apple Vinegar