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Quality System Requirements

ISO 13485:2016 MDSAP

The MDR require the QMS under which Class II, III or IV medical devices are designed and/or manufactured satisfy the National Standard of Canada CAN/CSA-ISO 13485:03 or CAN/CSA-ISO 13485:16. There are no regulatory QMS requirements for Class I medical devices. Health Canada considers CAN/CSA-ISO 13485:03 and CAN/CSA-ISO 13485:16 to be equivalent to ISO 13485:2003 and ISO 13485:2016, respectively.



Medical Device Single Audit Program (MDSAP)


​The International Medical Device Regulators Forum (IMDRF)  [disclaimer icon]  recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2003. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits.

International partners that are participating in the MDSAP include:

  • Therapeutic Goods Administration of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers


​MDSAP Transition Period

In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018. Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licences. To facilitate a smooth transition, Health Canada is encouraging manufacturers to begin the transition process in a timely matter to ensure compliance with the regulatory requirements at the end of the transition period.


Revised Version of ISO 13485

On March 1st, 2016, the International Organization for Standardization (ISO) published the revised version of ISO 13485 titled "ISO 13485 - Medical Devices - Quality management systems - Requirements for regulatory purposes". This revised version will supersede ISO 13485:2003. This revised standard is referred to as ISO 13485:2016.

Transition Period of ISO 13485

ISO will withdraw ISO 13485:2003 on March 1st, 2019, three years after the publication of ISO 13485:2016.

Health Canada has set March 1st 2019, as the transition date to ISO 13485:2016. All manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1st, 2019.


Obligation to Submit Certificate

In accordance with section 43.1 of the Medical Devices Regulations a manufacturer is required to submit to Health Canada a copy of any new or modified certificate within thirty days of the certificate being issued.

Failure of a manufacturer to transition to ISO 13485:2016 by the appropriate date or to comply with section 43.1 of the Medical Devices Regulations may lead to Health Canada taking compliance action against the medical device licences held by the manufacturer.


​Clarification - Manufacturers undergoing a full MDSAP audit in 2018

Manufacturers undergoing a full MDSAP audit in 2018 are expected to submit a valid MDSAP certificate with a form F202 (Submission of a New or Modified Quality Management System Certificate) to the Medical Devices Bureau by December 31st, 2018. However, Health Canada will not take enforcement action against manufacturers that can demonstrate that they have undergone an MDSAP audit in 2018, but have not received an MDSAP certificate by December 31, 2018. The Department recognizes that some manufacturers are facing challenges in scheduling MDSAP audits in 2018, and may not be issued their MDSAP certificate by December 31st, 2018 (as there is often a delay between the timing of the audit and the issuance of the certificate).

Maintenance of certification cycles through the MDSAP transition

To facilitate a timely transition to MDSAP, manufacturers who underwent an initial recertification audit to ISO 13485 under CMDCAS (on or after January 1, 2016), will now be allowed to transition into the MDSAP during the surveillance audit process. This will allow manufacturers to maintain their existing certification cycles. These manufacturers will need to demonstrate that they continue to hold a valid ISO 13485 certificate issued by an MDSAP Auditing Organization.

Manufacturers who transition to MDSAP during a surveillance audit will not receive an MDSAP certificate in 2018. However, this option provides manufacturers who would have been otherwise unable to transition before December 31, 2018, with the ability to continue selling their medical device(s) in Canada until they receive a MDSAP certificate.

Please note that manufacturers will only benefit from the international acceptability of an MDSAP once they obtain an MDSAP certificate (following a full certification audit).

Criteria for manufacturers seeking to transition to MDSAP via a surveillance audit

Manufacturers transitioning to MDSAP during a surveillance audit need to demonstrate to Health Canada that:

  • They have undergone an initial or recertification audit to ISO 13485 under CMDCAS on or after January 1st, 2016.
  • They hold a valid ISO 13485 certificate issued under CMDCAS that has a validity period to at least December 31st, 2018.
  • As of January 1st, 2019, they continue to hold a valid ISO 13485 certificate (non-CMDCAS) issued by an MDSAP Auditing Organisation, and
  • They have undergone an MDSAP surveillance audit or have made arrangements to undergo an MDSAP audit.


In addition applicable documentation is required to be submitted.


Mandatory Problem Reporting

Canada Regulations requires importers and manufacturers of medical devices to report certain incidents involving devices. 

Complaint Handling

Canada Regulations requires that manufacturers, importers and distributors to maintain records of reported problems regarding medical devices they have sold.

Distribution Records

Canada Regulations requires that manufacturers, importers and distributors each maintain records of distribution for each device sold. The distribution records must contain sufficient information to permit a complete and rapid withdrawal of the device from the market. The Regulations also specify minimum retention periods for distribution records and a manner of maintaining distribution records that will allow for their timely retrieval (section 56).

Canada Regulations

Medical Device Establishment Licensing (MDEL)

A manufacturer must obtain a license before importing, advertising or selling any Class II, III or IV device. A distributor of medical devices cannot legally sell unlicensed device. Additionally, distributors of medical devices are required to obtain an Establishment License from Health Canada.

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence with the exception of:
- A retailer - A healthcare facility - A manufacturer of Class II, III or IV medical devices who only sells: medical devices for which they hold a valid licence, or medical devices for custom-made, for special access of for investigational testing
- A manufacturer of a Class I medical device who imports or distributes solely through a licensed establishment, - A person solely selling medical devices subject to Parts 2 and 3 of the Regulations - A dispenser. 


Labelling

Any person who imports or sell a medical device must comply with Canada Labeliing Requirements.


Classification

The application for an MDEL must set out the classes of the medical devices that are being imported or sold by them.


Device Licensing

All Class II, III, and IV medical devices sold in Canada must have a valid Medical Device Licence issued by the Therapeutic Products Directorate of Health Canada before they may be sold. Class I devices do not require a licence.