What is MDSAP :

The Medical Device Single Audit Program (MDSAP) is a global initiative that allows medical device manufacturers to undergo a single regulatory audit of their Quality Management System (QMS) that satisfies the requirements of multiple jurisdictions. This program streamlines the audit process, reducing the regulatory burden on manufacturers.

Why is MDSAP Important ?

• Global Harmonization :

  • Facilitates the harmonization of regulatory requirements for medical devices across multiple jurisdictions.

• Efficient Resource Utilization :

  • Reduces the need for multiple audits, thereby saving time, effort, and resources for both manufacturers and regulators.

• Market Access :

  • Compliance with MDSAP can be a key to entering markets of participating countries, making it essential for manufacturers seeking international expansion.

Roles and Responsibilities in MDSAP :

• Auditing Organizations (AOs) :

  • AOs are authorized by MDSAP participating regulatory authorities to conduct audits. They assess the manufacturer’s QMS compliance with the regulations of the participating countries.

• Manufacturers :

  • Manufacturers are required to maintain a QMS that meets the standards of all MDSAP participating countries. They must undergo regular MDSAP audits to retain market access.

Auditing Organizations (AOs) Approved by the IMDRF :

The International Medical Device Regulators Forum (IMDRF) recognizes certain AOs that are authorized to conduct MDSAP audits. These AOs are responsible for assessing the compliance of a manufacturer’s QMS with the regulations of MDSAP participating countries. Examples of AOs include:

• BSI Group (British Standards Institution)
• DEKRA Certification
• Intertek Testing Services NA, Inc.
• SGS United Kingdom Limited
• TÜV SÜD America Inc.
• NSF International Strategic Registrations
• UL LLC
• DQS Medizinprodukte GmbH
• Lloyd’s Register Quality Assurance Ltd. (LRQA)
• Medcert GmbH
• SAI Global Certification Services Pty Ltd
• Eagle Registrations Inc

MDSAP Audit Process :

• Audit Planning and Preparation :

  • Comprehensive preparation, including understanding of MDSAP requirements and ensuring QMS compliance with all relevant regulations.

• Audit Execution :

  • AOs conduct the audit, covering all aspects of the QMS and its compliance with the regulatory requirements of the participating countries.

• Audit Reporting :

  • AOs provide a detailed audit report, which is shared with the participating regulatory authorities.

MDSAP vs. ISO 13485:2016 :

• Scope and Focus :

  • MDSAP: Focuses on auditing a manufacturer’s Quality Management System (QMS) for compliance with the specific regulatory requirements of the participating countries.
  • ISO 13485:2016: An international standard that specifies requirements for a QMS specific to the medical device industry, focusing on safety and quality.

• Regulatory Acceptance :

  • MDSAP: Recognized by the specific participating countries in the program, allowing for streamlined market entry into these regions.
  • ISO 13485:2016: Widely recognized internationally but does not replace the need for compliance with country-specific regulations.

• Audit Process :

  • MDSAP: Audits are conducted by AOs approved by the IMDRF and focus on compliance with the regulatory requirements of the participating MDSAP countries.
  • ISO 13485:2016: Can be audited by various certification bodies and focuses on meeting the standard’s requirements, not specific regulatory compliance.

Challenges in MDSAP :

• Complexity of Compliance :

  • Ensuring compliance with the diverse regulations of multiple countries can be complex and challenging.

• Resource Intensity :

  • Preparing for and undergoing an MDSAP audit requires significant resources and expertise.

• Continuous Improvement and Updates :

  • Keeping the QMS updated and continuously improving to meet the dynamic regulatory environment.

Conclusion:

MDSAP offers a harmonized approach to QMS auditing for the medical device industry, recognized by key global markets. It differs from ISO 13485:2016 in its specific focus on regulatory compliance, rather than general QMS requirements. Medfins International plays a pivotal role in assisting manufacturers to navigate these standards, ensuring compliance, and facilitating smooth market entry across MDSAP participating countries. Their expertise and support are invaluable for manufacturers aiming to capitalize on the benefits of MDSAP while adhering to the highest standards of medical device quality and safety.

How Medfins International Can Assist with MDSAP :

• Understanding MDSAP Requirements : Medfins International provides guidance on the specific requirements of MDSAP and how they align with the manufacturer’s current QMS.
• Preparation for MDSAP Audits : Assisting in preparing for MDSAP audits, including gap analysis, documentation review, and mock audits.
• Alignment with ISO 13485:2016 : Helping manufacturers understand the differences and similarities between MDSAP and ISO 13485, and ensuring their QMS aligns with both.
• Liaison with AOs : Acting as a liaison between the manufacturer and the AOs, facilitating the audit process.
• Continuous Compliance : Offering ongoing support to maintain compliance with both MDSAP requirements and ISO 13485 standards.