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 detention.
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 Regulations.