ISO 13485 with Medical Device Single Audit Program (MDSAP) and 93/42/EEC Medical devices Consultant

ISO 13485 consultants- Medical and Pharmaceutical

ISO 13485 with Medical Device Single Audit Program (MDSAP) and 93/42/EEC Medical devices Consultancy
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
1. What is the Medical Device Single Audit Program?
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.
The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”
2. Which Regulatory Authorities are part of the MDSAP and what is the plan for expansion of the program?
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA).
All regulatory authorities participating in the MDSAP are equal partners in the program.
Others Regulatory Authorities may eventually decide to participate in the MDSAP and to become active participants in the Program. For example, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observer to the MDSAP Regulatory Authority Council (RAC) and Subject Matter Expert (SME) Work Group.
3. What is 93/42/EEC Medical devices?
Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. However, in most cases, the use of an EU Notified Body is required to assess compliance with the Directive before the CE mark can be applied to a device.

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