MDSAP

In the dynamic landscape of the medical device industry, manufacturers face the challenge of complying with various regulatory requirements across different markets. The Medical Device Single Audit Program (MDSAP) is a transformative initiative that not only simplifies the regulatory landscape for medical device manufacturers but also offers a strategic advantage in a globally competitive market. Embracing MDSAP is more than a compliance requirement – it’s a strategic move toward efficiency, cost-effectiveness, and global market leadership. 

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) stands as a collaborative effort among regulatory authorities, including those from the United States, Canada, Australia, Brazil, and Japan. This initiative aims to conduct a singular regulatory audit of a medical device manufacturer’s Quality Management System (QMS). MDSAP Certification, acknowledged internationally, serves as accreditation affirming compliance with regulatory stipulations for medical devices across multiple countries. It simplifies the compliance process for manufacturers by enabling a single audit to fulfill Quality Management System (QMS) requirements set forth by participating regulatory authorities.

Which countries participate in the MDSAP Program ?

 The Medical Device Single Audit Program (MDSAP) enlists the collaboration of numerous countries, each actively participating in this endeavour to align medical device regulatory requirements. MDSAP assimilates the regulatory prerequisites of these participating countries, and the nations involved in the MDSAP encompass:

• United States (U.S.) – represented by the Food and Drug Administration (FDA): The FDA accepts MDSAP audit reports as a substitute for routine inspections, excluding “For Cause” or “Compliance Follow-up” inspections. The program doesn’t apply to pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications.
• Canada – represented by Health Canada: Health Canada acknowledges MDSAP for manufacturers marketing devices in Canada, making MDSAP Certification a requirement for placing products on the Canadian market.
• Australia – represented by the Therapeutic Goods Administration (TGA): TGA utilizes MDSAP audit reports as part of the evidence for assessing compliance with medical device market authorization requirements, with exceptions for excluded or exempt devices or instances where policies restrict the use of MDSAP reports.
• Brazil – represented by the Agência Nacional de Vigilância Sanitária (ANVISA): ANVISA incorporates MDSAP outcomes, including reports, as crucial inputs for pre-market and post-market assessment procedures, aiding regulatory technical evaluations when applicable.
• Japan – represented by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA): MHLW and PMDA leverage MDSAP audit reports in both pre-market and periodic post-market audits as per Japanese regulations.

What is the MDSAP Certification Cycle?

The MDSAP Certification Cycle operates on a three-year audit schedule:

• Initial Audit: This includes Stage I and Stage II audits. Stage I involves a review of documentation and an evaluation of readiness for the subsequent Stage II audit. Stage II verifies the implementation of ISO 13485 and other regulatory requirements.
• Surveillance Audits: Conducted annually in the first two years after the initial audit, these audits ensure continued compliance with MDSAP requirements and any updates in the regulatory landscape.
• Recertification Audit: Conducted in the third year, this audit reaffirms compliance with MDSAP standards. It is a comprehensive evaluation, akin to the initial audit, ensuring the ongoing adherence to quality management systems.

The MDSAP Certification Cycle, with its structured audits, ensures a robust and continual commitment to meeting global regulatory standards for medical devices.

Unlock Global Markets with Medical Device Single Audit Program (MDSAP) Seek QMS Consultant Support Today

How can 8C Healthcare help? 

8C Healthcare is well-equipped to assist manufacturers of medical devices, in vitro diagnostics (IVD), combination products, and digital health devices in achieving MDSAP compliance.

• Consultation and Assessment: We can assess the current state of your company’s quality management system and its readiness for MDSAP compliance. This includes reviewing existing processes, documentation, and systems.
• MDSAP Training: Providing training sessions for key personnel on MDSAP requirements ensures that the internal team understands the standards and processes. This helps in creating a culture of compliance within the organization.
• Gap Analysis: Conducting a thorough gap analysis to identify areas where a company’s current processes and procedures might fall short of MDSAP requirements. This analysis guides the development of an action plan for compliance.
• Documentation Support: Assisting in the creation, organization, and revision of documentation to meet MDSAP standards. This includes preparing the necessary documentation for the audit process.
• Audit Preparation: Preparing for an MDSAP audit involves ensuring that all relevant documentation is in order, training staff, and conducting internal audits. Healthcare service providers can guide companies through this process.
• Continuous Improvement Strategies: Offering strategies for continuous improvement in quality management systems, ensuring that organizations not only meet MDSAP requirements but also maintain a high standard of quality over time.
• Regulatory Intelligence: Keeping abreast of regulatory changes and updates to MDSAP requirements, and providing ongoing support to adapt to any changes in the regulatory landscape.
• Project Management: Overseeing the entire MDSAP compliance process, including coordinating with internal teams, managing timelines, and ensuring that all aspects of the compliance project are on track.
• Post-Audit Support: Providing support post-audit, including assistance with responding to audit findings and implementing corrective and preventive actions if necessary.
• Global Compliance Strategy: Helping companies develop a global compliance strategy that aligns with MDSAP requirements and other relevant international regulatory standards.

For expert guidance on navigating MDSAP compliance and ensuring a seamless regulatory journey, contact 8chealthcare today. Our dedicated team is ready to assist you in achieving and maintaining MDSAP Certification.