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QMS for Importers & Distributors

Overview​

Importers and distributors holding an MDEL must maintain a Quality Management System (QMS) that is appropriate for their role in the supply chain. The QMS requirements for importers and distributors are less extensive than for manufacturers, but are still legally required under the Medical Devices Regulations.

Importers and distributors are not required to hold an ISO 13485 certification or MDSAP audit certificate (those are required for manufacturers applying for Device Licences). However, a QMS that aligns with ISO 13485 is considered best practice.

Required QMS elements​

1. Complaint handling​

  • A procedure for receiving, recording, and evaluating complaints about devices
  • A process to investigate complaints and determine if they represent a reportable problem
  • Records of all complaints and their resolution

2. Distribution records​

  • Records identifying each device by: name, model/catalogue number, lot/serial number, quantity
  • Records showing: date of receipt, name and address of supplier; date of distribution, name and address of recipient
  • Records must be retained for a sufficient period to support recalls (minimum: expected lifetime of the device or 2 years after the last distribution, whichever is longer)

3. Recall procedures​

  • A documented procedure for initiating and executing recalls
  • Ability to identify and contact all customers who received a recalled lot/batch
  • Procedures for receiving, holding, and returning recalled devices
  • Records of recall activities

4. Mandatory problem reporting​

  • A procedure for identifying and reporting mandatory problems to Health Canada within required timeframes
  • Training for relevant staff to recognise reportable incidents
  • Process to escalate potential reportable incidents to the responsible regulatory personnel

Practical implementation​

For a small importer or distributor, the QMS may be implemented through:

  • A standard operating procedure (SOP) manual covering the four elements above
  • A complaint log and tracking spreadsheet
  • Distribution records maintained in an ERP or inventory system
  • A documented recall procedure tested through periodic drills

No specific documentation format is prescribed, but records must be adequate to demonstrate compliance during a Health Canada inspection.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 44–57; ss 58–65 (distribution records)