MDSAP Certification Process & Benefits

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 during 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 market access in up to five countries

Broad acceptance of MDSAP audit reports

Plannable audit content

Less impact on operative business

Participating MDSAP Countries

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

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.

Brazil: ANVISA (Agência Nacional de Vigilância Sanitária).

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

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.

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.

United States of America: FDA (U.S. Food and Drug Administration and Center for Devices and Radiological Health)

The 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.

What is involved in the MDSAP audit approach?

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 quote customized to the needs of your company or organization.

Once you have accepted our offer, an optional gap assessment is available to help you with the next steps leading up to the actual audit. 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 two stages, 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.

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 are happy to provide you with an individual quote.

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

Recognized expertise in medical devices for over 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

Basic data for the Medical Device Single Audit Program (MDSAP)

If you are interested in certification based on the Medical Device Single Audit Program, you have come to the right place.

We are pleased that you are interested in our certification and assessment services. We would be happy to provide you with a free, no-obligation quote.

To do so, we need some information about your organization. Please fill in the basic MDSAP data and send it to us. You can find more information in the document "Explanation of basic data MDSAP".

Download here

Every important information about MDSAP

Every important information about the MDSAP program can be found compactly and clearly on our flyer.

Here you can find our flyer

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MDSAP Medical Device Single Audit Program