Canada Brings Reprocessors Up to Speed on Regulations

May 13, 2016

Manufacturers of reprocessed single-use devices will have an extra year to comply with Canadian medical device regulations.

Health Canada compliance deadlines for reprocessed devices had originally been set for September 2016, but after meeting with stakeholders, the agency extended the deadline to September 2017 to provide manufacturers and reprocessors adequate time to meet the new requirements.

Companies engaged in reprocessing and distributing single-use devices will be held to the same requirements for licensing and registration as manufacturers of new devices according to Canadian Medical Devices Regulations. This includes requirements for:

  • Obtaining licensing;
  • Compliance with quality system management;
  • Device labeling;
  • Investigating and managing complaints;
  • Maintaining distribution records;
  • Conducting recalls and reporting incidents; and
  • Keeping Health Canada updated on any changes made to information in the license application.

Labels should clearly identify reprocessors as their manufacturers alongside instructions for safe reuse. Any single-use symbols should also be removed from reprocessed device labels.

The updated requirements do not apply to devices reprocessed on-site at hospitals; these products will continue to be overseen by provincial authorities.

Read the Health Canada Notice here: www.fdanews.com/05-10-16-HealthCanadaNotice.pdf. — Joya Patel