Abstract: . . .  accept inspection reports from other regulatory bodies as evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical Devices Regulations . 5.0 Manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 Page 11 Therapeutic Products Directorate Guidance on the Acceptance of Quality System Certificates before and after January 1, 2003 GD208/Rev0-MDB cmdcas_acceptance_of_certificate_rev0_e.wpd 2002-02-18 Page 9 of 9 Health Canada can not accept a manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 as objective evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical Devices Regulations . 6.0 Registration to other National quality system standards Health . . .
. . .  described in Sections 3.1 i) to vii) above. 4.0 Inspection reports Health Canada can not accept inspection reports from other regulatory bodies as evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical Devices Regulations . 5.0 Manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 Page 11 Therapeutic Products Directorate Guidance on the Acceptance of Quality System Certificates before and after January 1, 2003 GD208/Rev0-MDB cmdcas_acceptance_of_certificate_rev0_e.wpd 2002-02-18 Page 9 of 9 Health Canada can not accept a manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 as objective evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical . . .
. . .  from CMDCAS recognized registrars that reference ISO 13485:1996, ISO 13488:1996, CAN/CSA ISO 13485-1998 or CAN/CSA ISO 13488-1998 as the quality system standard audited against. Health Canada will accept quality system certificates that contain, in addition to the international ISO or the Canadian CAN/CSA national quality system standards mentioned above, a reference to other national or regional quality system standards.  . . .
. . .  from other regulatory bodies as evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical Devices Regulations . 5.0 Manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 Page 11 Therapeutic Products Directorate Guidance on the Acceptance of Quality System Certificates before and after January 1, 2003 GD208/Rev0-MDB cmdcas_acceptance_of_certificate_rev0_e.wpd 2002-02-18 Page 9 of 9 Health Canada can not accept a manufacturer’s self declaration of conformity to ISO 13485:1996 or ISO 13488:1996 as objective evidence of compliance to sections 32(2)(f), 32(3)(j) or 32(4)(p) of the Medical Devices Regulations . 6.0 Registration to other National quality system standards Health Canada will only accept . . .
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