To apply for MDSAP (Medical Device Single Audit Program) registration in the United States, manufacturers need to ensure that their Quality Management System (QMS) is in compliance with the regulatory requirements of the FDA and other participating countries. Although the specific documentation may vary based on the device and the auditing organization, here are the typical documents and records required for MDSAP registration:

1. Quality Management System (QMS) Documentation:

• QMS Manual: A comprehensive document that outlines the manufacturer’s quality management system, including policies, processes, and procedures. This should be based on 21 CFR Part 820 (FDA's Quality System Regulation), as well as relevant international standards such as ISO 13485.
• Standard Operating Procedures (SOPs): Detailed procedures covering various aspects of the QMS, including design control, production, labeling, complaint handling, and post-market surveillance.
• Work Instructions: Specific instructions related to day-to-day operations within the QMS, such as manufacturing, testing, and quality control processes.

2. Device Documentation:

• Device Master Record (DMR): This includes all the documents related to the design, production, and performance of the device. It may include specifications, drawings, design inputs/outputs, and testing protocols.
• Device History Record (DHR): A record that demonstrates the device has been manufactured according to the approved Device Master Record, including batch records and quality control data.

3. Regulatory Compliance Documents:

• FDA 510(k) or Premarket Approval (PMA): For devices that require FDA clearance or approval, copies of these documents must be submitted. This demonstrates compliance with FDA requirements for marketing medical devices in the U.S.
• Device Listing: A list of devices registered with the FDA, which must be updated periodically.

4. Audit-Related Documents:

• Internal Audit Reports: Reports of the manufacturer’s internal audits to assess the effectiveness of the QMS. These audits are typically conducted before the MDSAP audit.
• Corrective and Preventive Action (CAPA) Records: Documentation showing how the company addresses non-conformities and implements corrective and preventive actions to improve processes and compliance.

5. Risk Management Documentation:

• Risk Management Files: These files document the risk analysis and mitigation strategies for each device. The risk management process should follow ISO 14971, which provides guidelines for identifying and managing risks throughout the lifecycle of the device.

6. Training Records:

• Employee Training Records: Documentation showing that all personnel involved in the manufacture, testing, and distribution of medical devices are properly trained according to the QMS and regulatory requirements.
• Competence Records: Records verifying the competencies of personnel in key areas such as product testing, regulatory compliance, and quality assurance.

7. Supplier and Purchasing Control Documents:

• Supplier Qualification and Monitoring Records: Documentation showing how suppliers are selected, evaluated, and monitored. This includes contracts, supplier audits, and performance evaluations.
• Purchasing Records: Records for raw materials, components, and services purchased, including evidence of supplier approval and compliance with specifications.

8. Post-Market Surveillance Records:

• Complaint Handling Records: Documentation for how customer complaints are processed, investigated, and resolved.
• Adverse Event Reporting: Records related to reporting adverse events to the FDA and other regulatory bodies, including any Field Safety Corrective Actions (FSCA) taken.

9. Clinical Evaluation Documentation (if applicable):

• If your device requires clinical data for approval (e.g., for PMA or Class III devices), you will need to provide:
  • Clinical Investigation Reports.
  • Clinical Trial Protocols and associated data.
  • Informed Consent Forms (if applicable).

10. MDSAP-Specific Documentation:

• Audit Protocols: The manufacturer may need to submit protocols related to the scope of the MDSAP audit, including specific areas of the QMS that will be evaluated.
• Audit Response Records: Documentation demonstrating that previous audit findings or corrective actions have been addressed, particularly from internal or prior audits.

11. Other Regulatory Documentation:

• Depending on the device and its classification, the manufacturer may need to provide additional documents such as:
  • Import/Export Documentation: If the device is exported or imported to other countries, related documentation may be required.
  • Labeling and Packaging Information: Details on how the device is labeled, including instructions for use, warnings, and any required regulatory statements.

Summary of Documents Required:

1. Quality Management System Documents (QMS Manual, SOPs, Work Instructions).
2. Device Documentation (DMR, DHR).
3. Regulatory Compliance Documents (FDA 510(k), PMA, Device Listing).
4. Audit Records (Internal Audit Reports, CAPA Records).
5. Risk Management Files (Risk Analysis, ISO 14971).
6. Training and Competence Records.
7. Supplier and Purchasing Control Documents.
8. Post-Market Surveillance Documentation.
9. Clinical Evaluation Documents (if applicable).
10. MDSAP-Specific Audit Protocols and Responses.

Conclusion:

To apply for MDSAP registration in the United States, the manufacturer must submit comprehensive documentation demonstrating that their QMS meets the FDA's regulatory requirements, as well as those of the other participating countries (Canada, Brazil, Japan, and Australia). Having these documents in place will help facilitate a smoother audit process and ensure compliance with international regulations.

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