MDSAP – Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) is an international cooperation of different regulatory authorities with the objective of the global harmonization of regulatory requirements in the area of medical devices.

Thereby a simplified market entrance is presented to the manufacturers of medical devices within the member states.

Countries Included:

  • Australia

The Therapeutic Goods Administration (TGA) considers MDSAP audit reports during the evaluation, whether a manufacturer has proved the compliance with the requirements of the Australian conformity assessment procedure.

  • Brazil

The Agência Nacional de Vigilância Sanitária (ANVISA) considers the MDSAP – audit results including the MDSAP – audit reports as essential input for the ANVISA – market approval and monitoring procedures.

Furthermore, a MDSAP audit can speed up the ANVISA-GMP certification procedure, which is required for the market approval.

  • Canada

Health Canada (HC) accepts MDSAP-certificates for the issuance of a new or the maintenance of an existing Medical Device Licence for Medical devices class II, III or IV. Moreover, Health Canada is intending to implement the MDSAP program as an approach for the evaluation of the compliance with regulatory quality management system-requirements in Canada.

  • USA

The U. S. Food and Drug Administration (FDA) accepts MDSAP audit reports as replacement for FDA routine inspections.
The FDA evaluates MDSAP audit reports and considers as well, if necessary, the results of the tracing of the findings by the MDSAP audit body

  • Japan

The Pharmaceutical and Medical Devices Agency (PMDA) as well as the Ministry of Health, Labor and Welfare (MHLW) uses MDSAP audit reports as experimental model:

  1. To exclude a manufacturing site of an onsite inspection and/or
  2. To enable a Marketing Authorization Holder (MAH), to replace a considerately part of the inspection documents with a MDSAP audit report.

By a common standard for regulatory quality management audits, the regulatory approval requirements of the individual regulatory authorities can be covered within a single audit.

Maven Profcon Services LLP, being a Medical device consultants, can offer you GAP Analysis, Preparation of documents, Awareness training, MDSAP companion document implementation, mock audits, site visit and audit support. services to support you in your journey for regulatory approvals.

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