Important New Changes to Canadian Regulatory Quality Systems Requirements

Dear Manufacturer Letter

Dear Manufacturer,

This notice is to inform you that effective January 1, 2003, new Canadian regulatory quality systems requirements for medical devices took effect. These requirements apply to:

• All CANADIAN and FOREIGN manufacturers holding Class II, III and IV medical device licenses
• All CANADIAN and FOREIGN manufacturers applying for Class II, III and IV medical devices licenses
• All CANADIAN and FOREIGN manufacturers who have applied for Class II, III and IV medical devices licenses before January 1, 2003 and to whom those licenses are delivered after January 1, 2003

The Medical Devices Regulations do not require manufacturers of Class I devices, importers or distributors of medical devices to have a registered quality system.

The following websites contain important information on licensing requirements:

• http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui_mdel-doc_aeim_20051117_tc-tm_e.html (guidance documents),
• http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/form/frm_mdel-leim_20051216_tc-tm_e.html (application forms),
• http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/medical_devices_e.html (establishment licenses and post market)

For Class II devices, the manufacturer must satisfy ISO 13488-98 and for Class III and IV devices, the manufacturer must satisfy ISO 13485-98. To verify that these processes meet the required standard, manufacturers are required to have their quality systems registered by a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar. A list of Registrars that have received accreditation is available at: http://www.scc.ca/en/programs/iso_reg/accredited_clients_cmdcas.shtml. Additional guidance on quality systems and gaining registration from a CMDCAS recognized registrar is available at: http://www.scc.ca/en/programs/iso_reg/medical.shtml. It is important to note that Health Canada will not accept:

• ISO 9001/9002:1994 or ISO 9001:2000 certificates
• EN 46001/46002 certificates
• QS certificates issued to other countries’ or regional standards (e.g. EN ISO 13485:2000)
• FDA inspections
• Manufacturer’s self declaration of conformity

Obtaining a license also includes satisfying the safety and effectiveness requirements described in Sections 8-20 of the Medical Device Regulations and labeling requirements described in Sections 21-23. The Medical Device Regulations are available at: http://laws.justice.gc.ca/en/F-27/SOR-98-282/.

The recent regulatory amendment to the Medical Devices Regulations (Schedule 1162) is available at: http://laws.justice.gc.ca/en/showdoc/cr/SOR-98-282/bo-ga:l_2//en#anchorbo-ga:l_2. The pending regulatory amendment (Schedule 1293) is available at: http://laws.justice.gc.ca/en/showdoc/cr/SOR-98-282/bo-ga:l_1//en#anchorbo-ga:l_1.

Additional information is also available at http://www.hc-sc.gc.ca/ and at http://www.scc.ca/.