Canada's regulatory authorities have released a new guidance document on compliance and enforcement activities for medical devices.
Guidance on Medical Device Compliance and Enforcement (GUI-0073), released 10 August 2012, replaces an earlier 2008 guidance document by the same name, and is similarly aimed at promoting the manufacture and distribution of safe and effective medical devices.
"Health Canada relies on the premarket review process to provide a level of assurance with respect to the safety, effectiveness, and compliance of class III and IV devices prior to permitting their sale in Canada," it notes in the guidance. "Noncompliance with device licensing or authorization requirements presents a potential risk to health," as does failure to license devices or comply with postmarket requirements, Health Canada explained.
It is the company's responsibility to take prompt and appropriate actions to comply with Health Canada's requests, the agency explains, and failure to do so is grounds for subsequent enforcement action.
The guidance also notes the ability for Health Canada to use its discretion when making enforcement decisions so long as they are, "Justified by circumstances and supported by sound rationale."
"In general, companies are given an opportunity to take action in response to noncompliance," Health Canada wrote. "However, enforcement action(s) may be taken at any time during or after an investigation or inspection, where warranted by circumstances such as lack of cooperation or an inability to address the noncompliance."
A company's failure to respond to written notices, inspection reports or compliance orders will regularly lead to enforcement actions, explains the agency. Those actions may include warning letters, public notifications and safety alerts, product seizure, license suspensions, import refusal, injunction and prosecution.
Common Issues and a Formulaic Response
Health Canada explains in the guidance that it typically deals with five categories of compliance issues: failure to license or authorize a device, failure to license an establishment, failure to stop the sale of a Class I device, device-specific requirements and company-specific requirements.
A company found to have not licensed or authorized a device properly through Health Canada will be required to immediately stop its noncompliant activities, notify its customers, recall all nonconforming devices and confirm all actions taken to Health Canada.
Unlicensed establishments will be subject to sanctions if they do not cease all activities, and Health Canada notes it can pro-actively refuse to issue such a license if an establishment could reasonably harm public safety in the future and suspend current licenses if there are regulatory violations. Establishments may appeal either of these decisions.
Similar formulas to ensure compliance-an ordered halt of deficient activities, a review of actions and an assessment of risk, compliance with orders and subsequent action if compliance is not achieved-are similarly in place for marketing, device-specific and compliance-specific requirements.
As with guidance documents released by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Health Canada's guidance document is non-binding.