E-update - 09 December 2011
Since January 1, 2003, all Medical Device Manufacturers selling Class II, III and IV devices in Canada must be registered to ISO 13485 by a quality systems registrar recognized under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS).
Expiration Dates for CMDCAS Certificates
Under the CMDCAS program following a successful re-certification audit, the review date completed by a BSI Reviewer is the new Effective Date. According to the requirements of Health Canada, the new expiration date on the certificate will be three years from the effective date minus one day. For example, if a re-certification report is reviewed on July 15, 2011, the new effective date will be July 15, 2011 when the ISO 13485 under CMDCAS certificate is re-issued. The new expiration date will be July 14, 2014.
These requirements only apply to ISO 13485 certificates issued under CMDCAS, and NOT other ISO 13485 certificates, ISO 9001 or other scheme specific certificates. The alternative considered was to conduct re-certification reviews of CMDCAS certificates on the day before expiration and this was considered highly undesirable for manufacturers concerned about maintaining market access and confidence of continuity of certification.
Opportunities For Improvement (OFI)
For many years, it has been normal practice for many quality systems registrars to include OFI within assessment reports as one mechanism to add value to certification customers. Accredited registrars cannot provide consultancy services during quality systems audits, or advise in any way on how to correct any non-conformity. In the past, BSI has included OFI with assessment reports for information purposes only. The new Guidance Document 211 from Health Canada is mandatory for registrars recognized under the CMDCAS program to follow. It requires that recognized registrars do not record OFI within assessment reports. It is permitted to continue to write Observations within the report.
Angie Combs is the BSI CMDCAS Program Manager. She has almost 15 years experience working for BSI, including many years as a Medical Device Assessor. She is proficient in CMDCAS, CE Marking, Japan PAL and Environmental Management Systems. In addition, Ms. Combs has an extensive background in Quality Management Systems and laboratory testing. She may be reached at firstname.lastname@example.org