HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

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FEBRUARY 2017 - RELEVANT FOR: HEALTHCARE AND MEDICAL DEVICES

Health Canada will terminate the CMDCAS program on December 31, 2018. After this date Health Canada will only accept MDSAP certificates from manufacturers with their device applications or renewals. To facilitate uninterrupted market access TÜV SÜD will no longer be conducting CMDCAS audits as of September 30, 2017, and all audits for Health Canada after this date shall be carried out under the MDSAP program. Additionally, TÜV SÜD experts now offer support for the transition of existing certificates.

HOW CAN CURRENT CMDCAS CERTIFICATE HOLDERS PROCEED? 

It is recommended to CMDCAS certificate holders to plan now how to proceed further. They can choose between the following Options::

  • Leaving the CMDCAS program, i.e. losing the valid certificates for Canada.
  • MDSAP certification in 2017.
  • MDSAP certification in 2018.

WHAT IS THE MDSAP? 

The Medical Device Single Audit Program (MDSAP) will replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) within the next two years. From January 2019 Health Canada will only accept MDSAP certificates.

MDSAP is aimed at developing a single regulatory audit of a medical device manufacturer’s quality management system that will be mutually recognized by several countries (at present Australia, Brazil, Canada, Japan and USA). TÜV SÜD has been authorized to perform MDSAP audits at medical device manufacturers since 2014, and was one of the first auditing organizations to gain this Status.

WHAT ARE THE BENEFITS OF MDSAP?

  • Save time and increase efficiency by gaining access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.
  • Increase speed to market in Brazil by meeting Brazilian regulatory requirements through the MDSAP as there are currently more than 1,000 companies waiting to be inspected by ANVISA, an average backlog of 3 years. ANVISA will accept MDSAP for initial audits with the exception of certain higher risk devices.
  • Substitute FDA routine inspections and minimize manufacturing plant and personnel disruptions.
  • Combine MDSAP and MDD audits: TÜV SÜD offers joint audits integrating both requirements.

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