Health Canada CMDCAS
Manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485/ISO 13488 by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). For devices to be licensed by Health Canada, the requirement for registration of quality management systems is as follows:
- Class II manufacturers must be registered to at least ISO 13485:2003 by a CMDCAS accredited registrar,
- Class III and IV manufacturers must be registered to ISO 13485:2003 by a CMDCAS accredited registrar,
- Since 1 January 2003 all manufacturers of class II, III and IV devices are required to have been assessed by a CMDCAS accredited Registrar.
For medical device manufacturers registered under the CMDCAS program, Health Canada has established March 15, 2006 as the deadline for registration to the new standard. BSI is recommending Medical Device manufacturers, update their ISO registration to meet ISO13485:2003 standard before the end of 2005.
BSI Management Systems is a recognized registrar under the CMDCAS program.
Full details of the CMDCAS program can be found on the Standards Council of Canada website.
For further information on registration under the CMDCAS scheme, please contact us.
