Certification Profile

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.

Health care services – Quality management systems

Thereby a simplified market entrance is presented to the manufacturers of medical devices within the member states. These include according to the current state:

Member States

The Therapeutic Good 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 If the regulatory specifications of the manufacturer require a TGA Conformity Assessment Certificate, the TGA considers the MDSAP audit reports during their decision, to issue or maintain such a certificate; TGA inspections can hereby be avoid under certain conditions.

A TGA Conformity Assessment Certificate is necessary for manufacturers of medical devices, whose products contain the following components:

  • a medicine constituent,
  • a non-vital material of animal origin,
  • cells or substances of microbial or recombinant original,
  • derivatives of human blood or plasma.

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.
According to RDC 15/2014 and RE 2.347/2015, MDSAP audits can be used by ANVISA instead of ANVISA – market approval inspections, to issue a ANVISA-GMP certificate to a manufacturer of class III or class IV medical devices. Furthermore, a MDSAP audit can speed up the ANVISA-GMP certification procedure, which is required for the market approval. ANVISA can use MDSAP audits as an alternative to the full extent ANVISA inspections also for biannual renewal of the ANVISA GMP certificates.

For manufacturers, those ANVISA performed a previous inspection with a not satisfactory result and then consequently reject the application for certification, ANVISA may only begin using MDSAP reports, after anew, satisfactory ANVISA inspection.

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.

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:

To exclude a manufacturing site of an onsite inspection and/or

To enable a Marketing Authorization Holder (MAH), to replace a considerately part of the inspection documents with a MDSAP audit report.

Following manufacturing sites – Registered Manufacturing Sites (RMS) – cannot be excluded from an onsite inspection:

  • RMS, which produce medical devices with human / animal tissue,
  • RMS, which produce radioactive in-vitro diagnostics,
  • Sites of the Manufacturing Authorization Holders (MAH).

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 (DQS MED).

In addition, manufacturers have one month time (FDA-inspections: 15 weekdays) for the implementation of actions regarding critical non-conformities (of level 4 or 5). Different from FDA-inspections, manufacturers receive a corresponding certificate after the successful completion of a MDSAP-audit, which can offer market benefits.

Occasion-related inspections (“for cause” or “compliance follow-up”) cannot be replaced by a MDSAP audit. Also inspections related to Premarket Approval (PMA)-procedures(“pre-approval” and “post approval”), as well as inspections on product classification decisions according to section 513(f)(5) of the Food, Drugs and Cosmetics Act cannot be replaced by a MDSAP-audit.

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.