Quality management systems for medical devices in an international environment

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries in the course of a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

Harmonization of regulatory requirements

One procedure for up to fivefold market access

Broad acceptance of MDSAP audit reports

Plannable audit content

Less impact on operative business

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Participating regulators

Regulatory agencies participating in the MDSAP program and their significant use of MDSAP audit results:

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Australia: TGA (The Therapeutic Goods Administration).

The TGA considers MDSAP audit reports as a material input in the evaluation for granting or maintaining marketing authorization. Medical devices excluded from the program for certain reasons are exempt.

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Brazil: ANVISA (Agência Nacional de Vigilância Sanitária).

ANVISA uses the results of the MDSAP audit as an important input for pre-market and post-market assessments.

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Canada: HC (Health Canada)

Health Canada recognizes MDSAP as the only means by which manufacturers of Class ll, lll, and lV medical devices can demonstrate compliance with Canadian market regulatory requirements.

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Japan: MHLW (Ministry of Health, Labour and Welfare) & PMDA (Pharmaceuticals and Medical Devices Agency)

MHLW and PMDA use MDSAP audit reports as part of pre- and post-market assessments, with the following benefits:

  • Exemption of a manufacturing site from on-site inspection, and/or
  • Substitution of a significant portion of the required documentation as part of the Japanese Representative and Marketing Authorization Holder (MAH) inspection.
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United States of America: FDA (U.S. Food and Drug Administration and Center for Devices and Radiological Health)

FDA recognizes MDSAP audit reports as a substitute for its own routine inspections. However, inspections for cause or compliance follow-up inspections cannot be replaced by MDSAP audit reports.

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What is the MDSAP certification process?

In the first step, you discuss your company and the goals of an MDSAP certification with us. Based on these discussions, you will receive an individual offer tailored to the needs of your company or organization.

After acceptance of the offer and before the actual audit, a gap assessment or project planning meeting may be useful to prepare the next steps in the process. A gap assessment provides a good opportunity to identify strengths and improvement potential of the quality management system in advance. A project planning meeting can be useful, especially for larger projects, to plan and coordinate schedules that involve auditing multiple sites.

The assessment of your quality management system is performed in stages by means of a system analysis (stage 1) based on your QMS documentation and a subsequent on-site system assessment (stage 2), during which an experienced assessor evaluates the effectiveness of your processes for compliance with applicable requirements. The results are presented to you at a final meeting and summarized in an audit report. If the audit result is positive, the audit report includes the assessor's recommendation to issue the MDSAP certificate.

After the audit, the results are evaluated by the independent certification board of DQS Medizinprodukte GmbH (DQS MED). If all requirements are met, the assessor's certification recommendation is confirmed and you receive your MDSAP certificate.

Either semi-annually or annually, key components of the system are re-audited on-site for further improvements. The certificate expires after three years at the latest, but recertification is performed before expiration to ensure continued compliance.

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What does MDSAP certification cost?

The cost of certification depends primarily on the MDSAP processes and the number of country-specific requirements that need to be assessed during the audit. We will be happy to provide you with an individual offer.

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Why should my company be certified by DQS MED according to MDSAP?

  • Recognized expertise in medical devices for more than 20 years
  • Active participation in standards and technical committees
  • Broad product portfolio of various normative and legal certification programs from one source
  • Worldwide network with over 200 experienced assessors and experts
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Request a quote

Your local point of contact

We will be happy to provide you with a customized offer for your MDSAP certification.