Medical devices are regulated in Canada by Health Canada’s Therapeutic Products Directorate (TPD) and in the USA by the Food & Drug Administration (US-FDA). Medical devices are classified into one of Classes 1 to 4, where Class 1 represents the lowest risk, and Class 4 the highest risk. All Solarc/SolRx UVB phototherapy products are classified as “Class 2” in both Canada and the USA. Note: The US-FDA uses roman numerals instead of numbers for these classes, so in the USA, Solarc devices are “Class II”.
In Canada, Class 2 devices are subject to many controls, including: – Compliance to the Canadian Medical Device Regulations (CMDR) – Market authorization by means of initial and annual device licensing – Mandatory ISO-13488 or ISO-13485 Quality System and the associated annual 3rd party audits, and Mandatory Problem Reporting. The device licence listings for Solarc Systems can be found on Health Canada’s Medical Devices Licence Listing website at: www.mdall.ca. Click “Active Licence Search”, and use “Company Name” (Solarc). Alternatively, go to Health Canada’s Medical Device home page.
Note1: On July-21-2008, Solarc’s three Health Canada Medical Device Licenses (12783,62700,69833) were merged into one license (12783). The “First Issue Date” for all devices except the 1000‑Series now appear as July-21-2008; even though these devices were first licensed on June-16-2003 for 62700 (500‑Series) and Dec-02-2005 for 69833 (100‑Series). Also note that the 1000‑Series was first licensed in Feb-1993 by “Health and Welfare Canada” on Accession #157340, prior to Canada’s new Medical Device Regulations of May 1998.
Note2: All Solarc Systems’ UVB devices (UVB-Narrowband and UVB-Broadband) received Health Canada approval to add “Vitamin D Deficiency” to the “Indications of Use” (health conditions for which can be legally advertised) on the July 21, 2008 amendment of Solarc’s per Health Canada Device Licence #12783.
Note3: On January 05, 2011, Solarc received Health Canada approval to add our 4th device family, the E‑Series, to our existing Health Canada Device Licence #12783. Solarc’s Health Canada Medical Device Licence #12783 is shown at the bottom of this webpage.