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From CMDCAS to MDSAP: transitioning of all certificates necessary for Canada

From January 1, 2019, Canada will terminate CMDCAS (Canadian Medical Devices Conformity Assessment System) and adopt MDSAP (Medical Device Single Audit Program). From this date onward, the Canadian medical device approval authority Health Canada will only accept medical device applications or renewals which have MDSAP certification. To ensure a smooth transition process, TÜV SÜD will conduct audits in accordance with MDSAP instead of CMDCAS from September 30, 2017. Australia, Brazil, Canada, Japan, and the FDA of the USA likewise accept MDSAP certification. Our Canada experts will answer frequently asked questions and explain the transition process for 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.

 

More information on this subject:

MDSAP: Our services
Georg Bauer

Georg Bauer

Department Manager Foreign Affairs

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