• New mandatory medical device incident reporting rules proposed by Health Canada
• Scope includes all acute-care hospitals in Canada
• 30-day timeframe for incident reporting proposed

Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health.

A new Health Canada consultation paper  provides updates on the regulator’s effort to establish new incident reporting rules as authorized by the Protecting Canadians from Unsafe Drugs Act, or Vanessa’s Law, established in late 2014 to align Canadian medical device regulations more closely with global safety standards. 

Scope of the new medical device incident reporting requirements

Health Canada’s proposed mandatory reporting requirements would apply to all Canadian hospitals providing acute care services, where patients involved in serious medical device incidents would most likely seek treatment.

Hospitals would be required to report all serious medical device incidents in their facilities to Canadian regulators.

Besides devices and pharmaceuticals, the reporting rules would also cover biologic drugs that are not vaccines, disinfectants and radiopharaceutical products.

Required data for medical device incident reports

At minimum, hospitals would have to report the following data to Health Canada under the proposed rules:

• Institution name and contact details
• Name of device
• Names of device manufacturer and importer
• Description of incident warranting report

If possible, hospitals should also disclose device identifier numbers, patient outcomes and any contributing factors to an incident in question.

Timeframes for reporting to Health Canada

Health Canada would establish a 30-day timeframe for hospitals to report serious incidents; that is, institutions would have 30 days from when an incident is first documented to notify the regulator.\

Interested parties have until August 11, 2017 to submit comments to Health Canada regarding the proposed mandatory reporting rules.

Additional information on Canadian medical device regulations:

• Health Canada Medical Device License (MDL) registration support
• Health Canada adverse event reporting for medical devices
• Canadian medical device regulatory process chart