On August 10, 2012, Health Canada released an updated Guidance on Medical Device Compliance and
Enforcement (GUI-0073) to provide the medical device industry
with a clearer description of compliance and enforcement actions
relating to the Medical Devices Regulations and applicable
sections of the Food and Drugs Act. While the updated
guidance is largely unchanged from the previous version, there are
at least two additions in the update that manufacturers and
establishment licence holders should note.
First, where a company has been found by the Health Products and
Food Branch Inspectorate to be noncompliant with device licensing
or authorization requirements, the company may also be asked to
review other devices that they manufacture, import, or sell and
provide evidence of compliance with licensing and authorization
requirements. In addition, not only can an inspector issue a
stop-sale letter onsite during an inspection (or subsequently by
mail), but the inspector may also request a voluntary
Second, for Establishment Licences, the guidance has been
revised to explicitly state that pursuant to section 51.1(b) of the
Regulations, companies that do not submit an establishment
licence annual review application prior to April
1st will have their licence cancelled. A letter will be
sent by the Inspectorate to the establishment stating that the
company is to immediately stop all licensable activities and will
also request that the establishment confirm in writing that they
have ceased licensable activities.
This updated guidance supersedes the previous document issued by
Health Canada on August 22, 2008 and is applicable to any situation
of non-compliance under the Act or
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