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MDSAP - Medical Device Single Audit Program

By opting to use the MDSAP program, a medical device manufacturer calls upon the services of a recognized "auditing organization" (AO) to proceed with an evaluation of its Quality Management System (QMS) within the regulatory framework of 5 countries: Australia, Brazil, Canada, Japan, and the United States. MDSAP will become mandatory in Canada as of January 1st 2019.

Presentation of the certification

What are the guiding principles behind MDSAP?

MDSAP is a voluntary program that will become mandatory in Canada beginning on January 1st 2019 for all Class II, III and IV medical devices (MD). A medical device manufacturer is eligible to call upon the services of a recognized "auditing organization" (AO) to proceed with an evaluation of its Quality Management System (QMS).

LNE/G-MED has been authorized to conduct MDSAP audits. The certification contract is associated with a 3-year cycle.
During each audit, the conformity of the company's quality management system with requirements stipulated under 5 regulations is assessed. The program's cornerstone is the "audit model", i.e. a document that serves to guide the auditing procedure. Nothing prevents this document from being used to actually develop the QMS, since it introduces a specific audit protocol and step-by-step approach to calculating audit time intervals.

Audit reports are submitted to the 5 regulatory authorities for use within the process of managing certification applications. Each country retains sovereignty and establishes how the program may be assimilated into its own regulatory framework.

Transitioning between MDSAP and CMDCAS

Since 2014, Health Canada has allowed for certificates relative to both programs, depending on the manufacturer's preference, to be appended to the certification applications submitted for Class II, III or IV medical devices. As of January 1st 2019, only those certificates validated within the scope of the MDSAP program shall be accepted. This modification means that all companies holding a certification issued under the purview of the CMDCAS program must, beginning now, anticipate their transition to the MDSAP program.

From October 1st 2017 forward, LNE/G-MED will no longer be proposing the CMDCAS certification framework. Also of this date, in order to apply Health Canada's decision under optimal conditions, CMDCAS certificates will only be acknowledged as part of a program transition step from CMDCAS to MDSAP. No new CMDCAS certification contracts will be drawn up.

For companies currently holding a CMDCAS certificate, a commercial contract will define:

  • CMDCAS certification contract termination conditions,
  • the conditions imposed on implementing the MDSAP certification contract (which incorporates a bilateral commitment on initial MDSAP audit dates).

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Additional information

Obtaining certification

Begin your application to obtain certification within the scope of the CE marking program by requesting the "Quality Management System Certification" information questionnaire, with a simple click on the "Obtain a quote" button.

For more information on the certification process, a no-cost webinar is available:

Advantages and challenges inherent in the MDSAP program

See also...

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