MDSAP

Qserve can support you with the implementation of MDSAP requirements in your QMS

QMS

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions. The program uses ISO 13485:2016 as the common framework, adding country-specific regulatory requirements, e.g. as related to market authorization and registration, adverse event reporting etc. MDSAP does not take away from any product approval or registration requirements in the individual countries. 

 

CER

MDSAP

As part of the program, regardless of the outcome, the regulators of all participating jurisdictions can review the reports. Additionally, a database will be set up for these reports, so any of the participating countries can review reports associated with an organization or medical device, as well as trending non-conformities.

MDSAP is a way that medical device manufacturers can be audited once for compliance to regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

Each participant nation’s regulatory agency has mapped out its own plan for adoption:

  • FDA will accept MDSAP in lieu of routine inspection, but not for initial visits or “for cause inspections.”
  • Health Canada has taken the lead in the MDSAP program and is planning to replace CMDCAS with MDSAP in January 2019. Therefore, medical device manufacturers currently selling in Canada will have to obtain MDSAP certification.
  • ANVISA will accept MDSAP for initial audits. This will help with the country’s current backlog of inspections, but the agency will still require its auditors to conduct ANVISA audits for higher-risk devices.
  • TGA will use MDSAP to satisfy TGA requirements, considering MDSAP certificates as equivalent CE certificates.
  • MHLW will accept MDSAP in lieu of an on-site Japanese Quality Management System (J-QMS) audit.

    And as an official observer:
  • Europe (EU) has only been participating in the MDSAP pilot as an observer, as there are concerns it would be difficult to obtain agreement among all member states. However, the participation of European notified bodies in the program shows a strong link between EU and MDSAP. There is optimism the EU will join the program, though, as MDSAP’s aim to harmonize quality system compliance (ultimately increasing the safety and efficacy of medical devices) should serve as a way for EU to increase quality consistency across its member states. 

MDSAP

We offer MDSAP support in the following areas

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