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Important New Changes to Canadian Regulatory Quality Systems Requirements - "Dear Manufacturer Letter" |
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:
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:
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:
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://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/acts-lois/index_e.html.
The recent regulatory amendment to the Medical Devices Regulations (Schedule
1162) is available at:
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule.html#Part2.
The pending regulatory amendment (Schedule 1293) is available at: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule.html#Part1.
Additional information is also available at http://www.hc-sc.gc.ca and at
http://www.scc.ca.
Updated November 6, 2006
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