In December 2015, Health Canada announced the transition from CMDCAS (Canadian Medical Devices Conformity Assessment System) to MDSAP for organizations to obtain/maintain Canadian Medical Device Licenses for medical
devices classified as Class II, III or IV. MDSAP certification is required to sell medical devices in the Canadian market. Health Canada set the transitional deadline for medical device organizations to be compliant with the MDSAP program by January 1, 2019.

On April 13, 2018, Health Canada announced a minor modification to the MDSAP transition period. Health Canada will not take enforcement action against manufacturers if a company demonstrates they have undergone an MDSAP audit in 2018, but have not received an MDSAP certificate by December 31, 2018.

Medical Device Single Audit Program

Under the Medical Device Single Audit Program (MDSAP), the medical device manufacturers can let a recognized auditing body to conduct a single medical devices audit, for acceptance by the regulatory authorities of the participating countries. With the application of MDSAP, better alignment of regulatory approaches and technical requirements on medical devices can be expected in the future.


Currently, the participants for MDSAP include:

  • Food and Drug Administration (FDA) of USA
  • Health Canada (HC)
  • Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
  • Therapeutic Goods Administration (TGA) of Australia
  • Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil

The Official Observers of the MDSAP include:

  • The World Health Organization (WHO)
  • Prequalification of In Vitro Diagnostics (IVDs) Program
  • Program and the European Union (EU)

Audit Requirements

The MDSAP audit covers the requirements of:

  • ISO 13485:2003 / ISO 13485:2016 (Medical devices QMS Requirements for regulatory purpose)
  • Quality System Regulations (21 CFR Part 820) in USA
  • Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169) of Japan
  • Therapeutic Goods (Medical Devices) Regulations 2002 of Australia
  • Good Manufacturing Practices (RDC ANVISA 16/2013) of Brazil
  • Other specific requirements of participating regulatory authorities, such as requirements on medical device registration, technical documentation review, licensing, and adverse event reporting process.


Besides a certification body for ISO 13485:2016, a Notification Body for medical devices and CE marking, DQS Med, is an Audit Organization (AO) in the MDSAP program providing MSDAP audits covering all applicable requirements of the participating regulatory authorities. The MDSAP will help your organization to reduce internal resource with lower audit cost for access to different markets.
Contact us for answer to your questions on MDSAP for medical devices.

Training by DQS

DQS Academy provides ISO 13485:2016 Internal Auditor Training and ISO 13485:2016 Lead Auditor Training courses, to help clients get the required knowledge for medical devices QMS implementation.


Referenced Source: DQS Inc