MDSAP

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 and recognized 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.”

Why was MDSAP Program?

MDSAP was developed to reduce the burden of Regulatory audits for medical device manufacturers and to promote greater alignment of Regulatory approaches and technical requirements based on international standards and best practices. It focuses on bringing consistency, predictability, and transparency to Regulatory programs by standardizing procedures and practices of regulators and third-party auditing organizations.

The audit is based on QMS requirements under ISO 13485 and Regulatory requirements of the participating country where the medical devices will be marketed.

Eligibility criteria for undergoing an MDSAP Audit

Any medical device manufacturer intending to market their device in the participating countries can undergo an MDSAP audit. However, each Regulatory Authority may establish exclusion criteria for certain conditions if necessary.

MDSAP Benefits for Medical Device Manufacturers

MDSAP is expected to significantly reduce the number of audits from different regulatory bodies that are otherwise required to demonstrate a manufacturer’s continued compliance with the QMS requirements of each MDSAP regulatory agency, saving time and reducing interruptions to manufacturing operations. Specific benefits of MDSAP include:

• Broader acceptance of audit reports among participating regulators.
• More transparent and consistent oversight by regulators, including follow-up on audit findings.
• Use of MDSAP audit reports by regulatory authorities in the review of certain specific regulatory approval applications and incident reports.

ISO 13485:2016 certification for your company’s QMS compliance through the MDSAP, how member countries use MDSAP:

Australia – The TGA currently uses MDSAP audit reports and certificates as part of the evidence that is assessed for compliance with medical device conformity assessment procedures and market authorization requirements, unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

Brazil – ANVISA currently utilizes MDSAP audit reports in their certification decision for Brazilian GMP ANVISA certificates (ANVISA inspection is not required).

Canada – MDSAP certification is required to obtain a new (or maintaining or amend an existing) Class II, III or IV medical device license.

Japan – When an MDSAP audit report is submitted at the timing of premarket or periodical post-market QMS inspection application, Japan’s Ministry of Health, Version 018 2022-08-22 Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the report:

• To exempt a manufacturing site, etc., from on-site inspection (exceptions exist), and/or
• To allow a marketing authorization holder (MAH) to substitute a considerable part of the documents required for the inspection with the report.

United States – U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health will accept the MDSAP audit reports as a substitute for FDA routine inspections.

Medical Device Single Audit Program Process

Similar to other management system audit programs, MDSAP is based on a three-year audit cycle conducted in accordance with the requirements of ISO/IEC 17021:

• Stage 1 initial certification audit – Review of documentation and overall preparedness. Typically includes a review of the planning documentation.
• Stage 2 initial certification audit – Evaluate QMS compliance to ISO 13485, as well as other requirements of MDSAP-participating regulatory authorities.
• Surveillance audits – A surveillance audit is conducted annually to also assess any changes in the manufacturer’s products or QMS processes since the initial certification audit.
• Recertification audit – Conducted in the third year to evaluate a manufacturer’s QMS for its continued suitability and effectiveness in meeting QMS requirements under MDSAP.

The Role of MDR Consultants in MDSAP

Navigating the intricacies of MDSAP can be complex. MDR consultants offer invaluable expertise to guide you through the entire process, including:

• Eligibility Assessment: Determine if your company qualifies for an MDSAP audit.
• Gap Analysis: Identify areas where your current QMS may not align with MDSAP requirements.
• Preparation for Audit: Ensure your QMS is optimized for a successful MDSAP audit.
• Liaison with Regulatory Authorities: Facilitate communication between your company and relevant regulatory bodies.
• Post-Audit Support: Address any findings or corrective actions arising from the audit.

Partnering with MDR consultants can significantly increase your chances of a successful MDSAP audit and smoother market entry for your medical devices.