MDSAP: Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) sets internationally standardized requirements for the quality management systems of medical device manufacturers.

Participating countries and associated regulatory bodies include:

• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• U.S. Food and Drug Administration (FDA)
• 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) Programme
• 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
• South African Health Products Regulatory Authority (SAHPRA) (NEW)
• Taiwan Food and Drug Administration (TFDA)

Medical device manufacturers that want to sell their products in MDSAP-participating countries may need MDSAP (Medical Device Single Audit Program) certification. For example, while the program is voluntary in Australia, Brazil, Japan, and the United States, it is mandatory in Canada.

The program can streamline and simplify regulatory compliance, regardless of whether it is required.

To earn a MDSAP certification, medical device manufacturers can follow a few general steps. However, depending on the type of organization or device, you may need to slightly adjust your approach. Be sure to consult with the regulatory bodies in your region.

• Choose an Auditing Organization (AO). MDSAP audits are performed by MDSAP-recognized AOs, not government agencies. You must select and contract one. A list of approved AOs is available on the FDA’s website
• Prepare for the audit. Implement a quality nanagement system (QMS) that aligns with ISO 13485 and the specific requirements of MDSAP. You should also review MDSAP audit model documents to understand what will be assessed, as well as conduct an internal audit to identify and fix any skill gaps you discover
• Undergo the MDSAP audit. The AO will perform a Stage 1 (document review) and Stage 2 (on-site) audit. They check compliance with both ISO 13485 and country-specific regulations, such as the FDA’s Quality System Regulations and Health Canada’s Medical Device Regulations
• Receive the audit report and address findings. If non-conformities are found, you must provide corrective actions. Once approved, the AO issues a certification valid for three years, with annual surveillance audits

MDSAP certifications are valid for three years. During the first two years, certified organizations are subject to annual surveillance audits. In the third year, they will under a recertification audit.

A MDSAP certification offer several benefits to employees and their organizations. Some key advantages include the following

Earning a MDSAP certification may pose several challenges to employees and organizations. They include the following.

Here are a few tips for preparing for a MDSAP certification:

• Read or study the FDA’s MDSAP documents
• Familiarize yourself with the countries participating in MDSAP
• Conduct a skill gap analysis of requirements
• Train staff on the MDSAP audit process
• Perform internal audits before certification

For more information and guidance on MDSAP certification, you can refer to the following resources:

International Medical Device Regulators Forum. The IMDRF provides links on its website to each governmental agency and regulatory body that is part of MDSAP. It’s a great source of country-specific resources for organizations seeking MDSAP certification

Governmental agencies. The websites of governmental agencies like the FDA offer a wealth of resources for organizations seeking MDSAP certification. Choose the agency most relevant to your country.

AG5 stores all certifications in the cloud, providing all authorized personnel with access to the right version of approved certifications. This helps you easily keep track of all data and documentation related to a MDSAP certifications across your organization.

Using AG5’s skills management software, you can monitor the status of any type of certification that is relevant to your workforce, leveraging intuitive dashboards that provide you with a clear understanding of exactly what is needed to keep your employees skilled and safe.

• FDA
• IMDRF