The requirements for MDSAP (Medical Device Single Audit Program) registration of a Class I medical device in the United States involve several key factors to ensure that the manufacturer’s processes, quality management system (QMS), and products meet the necessary regulatory standards. Here are the primary requirements for MDSAP registration:

1. Compliance with ISO 13485

• Requirement: Manufacturers must have a Quality Management System (QMS) that complies with the ISO 13485 standard. This international standard outlines the requirements for a comprehensive QMS specific to the medical device industry, including design, development, manufacturing, risk management, and post-market surveillance.
• Action: The manufacturer’s QMS must cover all relevant areas including document control, supplier management, production processes, and customer feedback.

2. FDA Quality System Regulation (QSR) Compliance

• Requirement: For Class I medical devices, the manufacturer must also ensure compliance with the FDA’s Quality System Regulation (QSR) (21 CFR Part 820).
• Action: This includes having appropriate processes in place for product design, manufacturing, packaging, labeling, and post-market activities. Even though FDA QSR may not be as extensive for Class I devices as for higher-risk devices, it is still a necessary requirement.

3. ISO 13485 Certification

• Requirement: Manufacturers must be able to provide evidence of ISO 13485 certification by an accredited body. This certification demonstrates that the manufacturer’s QMS has been audited and found to meet the international quality standards for medical devices.
• Action: This certification is essential before applying for MDSAP registration, as the MDSAP audit will evaluate the QMS against both ISO 13485 and FDA QSR requirements.

4. MDSAP-Recognized Auditing Organization (AO)

• Requirement: The manufacturer must undergo an audit by an MDSAP-recognized Auditing Organization (AO). AOs are responsible for conducting the MDSAP audit and issuing the MDSAP certificate.
• Action: The manufacturer must choose an approved AO and schedule the audit. The AO will assess compliance with ISO 13485, FDA QSR, and other MDSAP participant country requirements (e.g., Health Canada, ANVISA in Brazil, TGA in Australia, etc.).

5. FDA Registration and Device Listing

• Requirement: In addition to MDSAP certification, the manufacturer must complete FDA establishment registration and device listing for Class I medical devices.
• Action: While Class I devices are exempt from the FDA user fees, manufacturers are still required to register their establishments and list their devices with the FDA. This is a separate step from the MDSAP audit but must be completed for U.S. market access.

6. Post-Market Surveillance and Corrective Action Process

• Requirement: Manufacturers must have processes in place for post-market surveillance and corrective actions if needed.
• Action: This includes tracking and investigating complaints, performing root cause analysis, and ensuring that corrective and preventive actions (CAPA) are effectively implemented when issues arise with the device.

7. Preparation for the MDSAP Audit

• Requirement: Manufacturers must ensure they are fully prepared for the MDSAP audit. This includes having all necessary documents, records, and processes in place.
• Action: The manufacturer should conduct internal audits, review their QMS processes, and ensure that any potential gaps are addressed before the external MDSAP audit begins.

8. Corrective Action and Compliance

• Requirement: If any non-conformities are identified during the MDSAP audit, the manufacturer must take corrective actions.
• Action: Corrective actions must be implemented to address any issues found during the audit. Manufacturers need to demonstrate their ability to resolve non-conformities and ensure ongoing compliance with the applicable standards.

9. Ongoing Surveillance and Audits

• Requirement: After achieving MDSAP certification, manufacturers must undergo periodic surveillance audits to maintain their certification.
• Action: Surveillance audits typically occur every 1 to 3 years and ensure that the manufacturer continues to meet MDSAP standards.

Summary of Key Requirements for MDSAP Registration of a Class I Device:

1. ISO 13485 Compliance: A certified QMS in line with ISO 13485.
2. FDA QSR Compliance: Adherence to FDA’s Quality System Regulation for Class I devices.
3. ISO 13485 Certification: Proof of certification by an accredited body.
4. MDSAP-Recognized Auditing Organization: Choose and schedule an audit with an approved AO.
5. FDA Registration & Device Listing: Complete FDA establishment registration and device listing.
6. Post-Market Surveillance: Systems in place for complaint handling, corrective actions, and ongoing monitoring.
7. Preparation for Audit: Ensuring readiness for the MDSAP audit with all required documentation and processes.
8. Corrective Actions: Ability to address any non-conformities identified during the audit.
9. Ongoing Compliance: Regular surveillance audits to maintain MDSAP certification.

Estimated Timeframe:

• Achieving MDSAP certification for a Class I medical device may take 4 to 12 months, depending on the manufacturer’s preparedness and audit process.

These requirements ensure that manufacturers are well-prepared to meet both U.S. FDA regulations and international medical device standards.

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