Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organisations (Certification Bodies) performing regulatory audits of medical device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements are applicable to regulatory authorities, as well as third-party organisations that conduct such audits.

The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.

 

The MDSAP program includes 5 participating regulatory authorities:

• TGA approval process (Australia’s Therapeutic Goods Act)
• Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) Health Canada (HC)
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA)
• U.S. Food and Drug Administration (FDA)
• Various other Regulatory jurisdictions may also utilize MDSAP by accepting the reports and certificates issued by Recognized Auditing Organizations. The program includes official Observers and affiliate members:

 

MDSAP Official Observers:

• European Union (EU)
• Singapore's Health Sciences Authority (HSA)
• United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program

 

MSDAP Affiliate Members:

• Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
• Ministry of Health of Israel
• Kenya’s Pharmacy and Poisons Board
• Republic of Korea's Ministry of Food and Drug Safety
• Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
• TDA – Taiwan Food and Drug Administration

 

Program Eligibility:

• Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and will be subject to their quality management system requirements.
• Manufacturers located anywhere in the world are eligible to participate. Only the participating MDSAP countries will have direct access to the audit reports.
• Manufacturers cannot select which of the 5 regulatory schemes are to be included within the audit scope. All country specific requirements of the manufacturer's target sale countries must be included. (This applies to the current 5 participating MDSAP countries only - Australia, Brazil, Canada, US and Japan)

 

Note: Regulators will be witnessing some audits. This will be for the evaluation of the Auditing Organisation, not the manufacturer.

By following the MDSAP Audit Approach:

• TÜV SÜD will perform MDSAP audits in a consistent manner across auditing organisations. This will help you gain access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.
• Our experts will conduct audits logically and efficiently, with attention to the interactions between processes. You can reduce routine inspections and minimise manufacturing plant and personnel disruptions.
• Auditors will be able to determine whether systemic quality management system nonconformities are present.   

Each participating regulatory uses the MDSAP as follows:

TGA approval process (Australia’s Therapeutic Goods Act)

TGA uses the MDSAP audit report as part of the evidence to support a Conformity Assessment Certificate application or change application unless the Medical Device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports. Australian Sponsors also use MDSAP Certificates when including a device on the ARTG.

The Brazilian National Health Surveillance Agency ANVISA (Agência Nacional de Vigilância Sanitária)

ANVISA utilises the outcomes of the program, including the reports, as input to ANVISA’s pre-market and post-market assessment procedures, by providing, when applicable, key information that is expected to support the regulatory technical evaluation on these issues.

Health Canada (HC)

Manufacturers of medical devices in classes II, III or IV wishing to apply for or maintain a Canadian Medical Device Licence must undergo an MDSAP audit to demonstrate that their products are in compliance with the requirements of the Canadian Medical Devices Regulation and ISO 13485.

US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)

FDA accepts the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA are not affected by the program. Moreover, MDSAP does not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval (PMA) applications or combination products

Japan Ministry of Health, Labor and Welfare

Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) uses the MDSAP audit report to exempt some manufacturers etc.* from on-site inspection, and/or to allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.

*Exceptions:

• A Registered Manufacturing Site (RMS) which manufactures medical devices made of human/animal tissues,
• A RMS which manufactures radioactive IVD, and
• An establishment of a MAH.

TÜV SÜD is a Certified Body for medical devices, authorised to work with clients who would like to participate in the MDSAP. To give manufacturers flexibility, TÜV SÜD can combine MDSAP Audits with prescheduled annual audits such as those within the scope of European Regulations or as a separate audit dedicated to the MDSAP Audit Approach. 

As the leading Certification Body in the medical device industry, TÜV SÜD takes a proactive approach in informing our customers about the regulatory changes concerning the industry.