Proposed Amendments to the Product Safety regulation (O. Reg. 438/07) under the Electricity Act, 1998
Bill or Act:
Summary of Proposal:
The Electrical Safety Authority (ESA) has been mandated with the responsibility to monitor and enforce compliance with the requirements set out in Part VIII of the Electricity Act, 1998, the regulations made under that Part, and the Ontario Electrical Safety Code (OESC). ESA also deals with broader safety issues associated with electrical safety throughout Ontario. The passage of Bill 152 and the Product Safety regulation (O. Reg. 438/07) has enshrined ESA's role and responsibility for electrical product safety. The broad electrical product safety scope of this regulation also captured electro-medical devices.
It is proposed that electro medical devices be exempted from certain sections of the Product Safety regulation (O. Reg. 438/07) as Health Canada has existing regulatory oversight in this area across Canada. Exempting electro-medical devices from certain sections of the Product Safety regulation would address the regulatory duplication that currently exists with federal requirements and reduce burden on the business community in this sector.
Electro-medical devices will not be exempt from the requirement to be certified by an ESA recognized (and Standards Council of Canada accredited) certification body/field evaluation agency in order to be approved for sale or use in Ontario. This approach is consistent with that of other provinces and territories across Canada.
Currently through the federal Food and Drugs Act and the Medical Devices regulations, Health Canada regulates electro-medical devices in Canada (with the exception of certification/approval requirements).
Health Canada's existing medical device regulations comprehensively cover firms or individuals involved in the manufacturing, importing, advertising or selling of medical devices. This includes requirements around incident reporting, inspections, compliance verifications, risk communications, investigations and may include a licensing requirement depending on product classification. The Compliance Unit of Health Canada also has the authority to recall a product.
The Medical Devices Bureau (MDB) of Health Canada's Therapeutic Products Directorate (TPD) is responsible for overseeing the authorization of all medical devices, whether domestic or imported. After a medical device is approved and available for sale in Canada, Health Canada's inspectorate monitors compliance with Canadian regulations and guidelines.
Health Canada reviews all incident reports received, including those from the Electrical Safety Authority, and actions them in accordance with their compliance and enforcement policy.
Ontario and Health Canada would work jointly to ensure that respective roles and responsibilities in the management of electro-medical devices are clearly defined.
The Ministry of Consumer Services seeks comments on this proposed amendment. To view the Product Safety regulation, see link below.
May 5, 2011
Comments Due Date:
May 13, 2011
Ministry of Consumer Services
Public Safety Branch
777 Bay Street, 5th Floor
Toronto, ON M7A 2J3
Attention: Kirsten Mania, Senior Policy and Program Analyst (DAA Liaison)