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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 I to IV, where Class I represents the lowest risk, and Class IV the highest risk.
All Solarc/SolRx UVB phototherapy products are classified as "Class II" in both Canada and the USA.
In Canada, Class II 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
- 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.
Note:
On July-21-2008, Solarc's three Health Canada Medical Device Licences
(12783,62700,69833) were merged into one licence (12783).
The "First Issue Date" for all devices except the 1000 Series now appear as July-21-2008;
even though these devices were first licenced on June-16-2003 for 62700 (500 Series) and
Dec-02-2005 for 69833 (100 Series).
Also note that the 1000 Series was first licenced in Feb-1993 by
"Health and Welfare Canada" on Accession #157340,
prior to Canada's new Medical Device Regulations of May 1998.
In USA, Class II devices are also subject to many controls, including:
- Compliance to the applicable sections of the Code of Federal Regulations (CFR)
- Market authorization by means of initial 510(k) application and ruling of substantial equivalence
- Submission of Initial & Product Change reports to the Center for Devices and Radiological Health (CDRH)
- Device Listing (One per product code)
- Mandatory "Good Manufacturing Practises" (GMP) Quality System
- Mandatory problem reporting.
The US-FDA does not permit marketing use of 510(k) or other regulatory information.
However, this information can be legally obtained from US-FDA/CDRH website at:
www.fda.gov/cdrh.
On the right side, go to Information Resouces>Databases, where you can search Premarket Notifications 510(k)'s and Device Listings.
Search using "Applicant Name" (Solarc) or "Owner/Operator Name" (Solarc).
Use the following links to the FDA's database searches:
510(k) Database Search
Device Listing Database Search
Physician Prescriptions
It is Solarc's long standing policy to collect a physician prescription for all home UVB phototherapy device sales worldwide.
In the USA, this is mandated by law because UVB phototherapy devices are subject to the Code of Federal Regulations [21CFR801.109] "Prescription Devices".
This forces the labeling to state "Caution: Federal law restricts this device to sale by or on the order of a physician."
In Canada, the Canadian Medical Device Regulations: Safety and Effectiveness Requirements
[PART 1, Section 10(c)] has a similar requirement to "reduce the risks to the extent possible",
and "provide protection appropriate to those risks".
The requirement for a physician prescription is reasonable because:
- The physician's diagnosis is needed to assess if UVB phototherapy is the best treatment option.
- The physician is in the best position to judge if the patient is likely use the device responsibly.
- The physician plays a role in the ongoing safe use of the device, including regular follow-up skin exams.
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Physician approval or prescription is required for all Ultraviolet Phototherapy device or lamp orders.
Solarc Systems Inc., 12 Parker Court, Barrie, ON, Canada L4N 2A6
Toll Free: 1.866.813.3357 Tel: 705.739.8279 Fax 705.739.9684
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