To apply for MDSAP (Medical Device Single Audit Program) registration for Class II medical devices in the United States, the following requirements must be met:

1. Compliance with ISO 13485:2016

• Requirement: Your company must have a quality management system (QMS) that complies with ISO 13485:2016, the international standard for medical device quality management systems.
• Why It's Important: MDSAP is based on the ISO 13485 standard and requires that manufacturers demonstrate their ability to consistently produce medical devices that meet both customer expectations and regulatory requirements. ISO 13485 serves as the foundation for the audit and certification process.

2. FDA Regulations (21 CFR Part 820) Compliance

• Requirement: For Class II devices, your quality management system must also comply with the FDA's Quality System Regulation (QSR) under 21 CFR Part 820.
• Why It's Important: The FDA's QSR is part of the MDSAP audit scope and is aligned with ISO 13485, but it includes specific FDA requirements for device manufacturing, labeling, and documentation.

3. Selection of an Accredited MDSAP Auditing Organization

• Requirement: You must select a recognized MDSAP Auditing Organization (such as BSI, TÜV SÜD, NSF, or Intertek) accredited by the MDSAP consortium to perform the audit and issue the certification.
• Why It's Important: The auditing body will conduct the MDSAP audit to verify that your QMS meets the regulatory requirements of the United States (FDA), Canada, Brazil, Japan, and Australia.

4. Device Classification and Compliance

• Requirement: Ensure that your device is classified as a Class II medical device in the U.S., as MDSAP applies to devices regulated by the FDA.
• Why It's Important: The device classification determines the level of regulatory oversight, and Class II devices have specific requirements such as premarket notification (510(k)).

5. Documentation and Record Keeping

• Requirement: You must maintain accurate and up-to-date records that demonstrate compliance with both ISO 13485 and the FDA regulations (e.g., design control, risk management, labeling, post-market surveillance).
• Why It's Important: Documentation is critical for the audit process. You will need to provide evidence of compliance with regulatory requirements, including device specifications, risk assessments, and post-market surveillance data.

6. Internal Quality Audits

• Requirement: Conduct internal audits of your quality management system to identify and address any potential gaps before the MDSAP audit.
• Why It's Important: Pre-audit internal assessments help ensure that your processes are in place and compliant, which can minimize issues during the official MDSAP audit.

7. Corrective and Preventive Actions (CAPA) System

• Requirement: Implement a robust CAPA system to identify, investigate, and resolve quality issues. Your system must be capable of tracking and preventing non-conformities.
• Why It's Important: MDSAP audits assess the effectiveness of your CAPA system. The ability to quickly identify and resolve quality issues is critical for passing the audit.

8. Ongoing Surveillance and Re-certification

• Requirement: Once certified, you must undergo annual surveillance audits to maintain MDSAP certification.
• Why It's Important: Surveillance audits ensure that your QMS continues to meet the requirements of MDSAP and the regulatory agencies involved. Failure to pass surveillance audits can result in the loss of certification.

9. Personnel Training

• Requirement: Ensure that your team is properly trained in quality management practices, the regulatory requirements for your Class II device, and the MDSAP audit process.
• Why It's Important: Well-trained personnel help ensure that your QMS is correctly implemented and maintained, which is essential for passing the MDSAP audit.

10. Global Regulatory Knowledge

• Requirement: Familiarity with the regulatory requirements of the FDA, Health Canada, Brazilian ANVISA, Japanese PMDA, and the Australian TGA, as MDSAP evaluates compliance across multiple countries.
• Why It's Important: Understanding the specific regulatory requirements for each jurisdiction ensures that your medical device meets the standards of all the MDSAP-participating countries.

Summary of Requirements for MDSAP Registration:

1. Compliance with ISO 13485:2016 (QMS standard).
2. FDA Regulations (21 CFR Part 820) for Class II devices.
3. Selection of an Accredited MDSAP Auditing Organization.
4. Device Classification (Class II devices in the U.S.).
5. Documentation and Record Keeping.
6. Internal Audits of your QMS.
7. Effective CAPA System.
8. Ongoing Surveillance Audits.
9. Personnel Training.
10. Knowledge of Global Regulatory Requirements.

By ensuring compliance with these requirements, you can successfully navigate the MDSAP registration process and gain certification for your Class II medical devices in the U.S. and other MDSAP-recognizing countries.

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