ISO Certification of Manufacturing Processes Only?

The following question was posed to Health Canada by ITAC Health

The wording of the regulations with respect to the ISO 13485
certification for Class II devices, in particular section 32(2)(f),
states that the QMS certificate under which the device is “manufactured”
must satisfy the requirements for ISO 13485. The corresponding sections
for Class III and Class IV devices explicitly state, “designed and
manufactured”. This implies that certification of design processes is
not required for a Class II license.


Section 1.2 of ISO 13485 states, “If regulatory requirements permit
exclusions of design and development controls (see 7.3), this can be
used as a justification for their exclusion from the quality management
system. These regulations can provide alternative arrangements that are
to be addressed in the quality management system. It is the
responsibility of the organization to ensure that claims of conformity
with this International Standard reflect exclusion of design and
development controls [see 4.2.2 a) and 7.3].”


Will Health Canada issue a Class II Licence to a manufacturer whose design and development processes have not been included in their Quality Management Systems Certificate (i.e. only manufacturing processes included), where they have included in their documentation the appropriate disclaimers to that effect as permitted by ISO 13485?


Reply from Health Canada

Section 32 (2) (f) of the Medical Devices Regulations states that the
manufacturer of a Class II device must provide the following:

a copy of the quality management system certificate certifying that the
quality management system under which the device is manufactured
satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical
devices — Quality management systems — Requirements for regulatory
purposes

Although it is not stated in the Regulations that for Class II medical
devices the quality management system certificate must also certify the
quality management system under which the device is designed, it is
strongly recommended that design be included in the scope of the ISO
13485:2003 certification when the device is a software product.

If a manufacturer submits a Class II application with a valid ISO 13485:2003 certificate that excludes design and development, Health Canada will not reject the application for that reason. (Note - emphasis in bold added by ITAC Health)