The process for MDSAP (Medical Device Single Audit Program) registration of a Class I medical device in the United States involves several key steps. Below is a general overview of the process:

1. Establish a Compliant Quality Management System (QMS)

• Requirement: Before applying for MDSAP certification, manufacturers must ensure that their Quality Management System (QMS) complies with ISO 13485 and FDA’s Quality System Regulation (QSR).
• Action: Manufacturers must establish, implement, and maintain a QMS that addresses the requirements of both standards, which include documentation, process controls, risk management, and corrective actions.

2. Select an MDSAP-Recognized Auditing Organization (AO)

• Requirement: MDSAP audits are conducted by MDSAP-recognized Auditing Organizations (AOs).
• Action: Manufacturers must choose an approved auditing organization that is authorized to perform MDSAP audits. Common AOs include entities like BSI, SGS, TÜV SÜD, and Intertek. The chosen AO will guide the manufacturer through the audit process.

3. Prepare for the MDSAP Audit

• Requirement: Manufacturers must be fully prepared for the audit, ensuring that all processes, documents, and records meet the requirements.
• Action: This involves reviewing and refining internal processes, training employees, and ensuring all documents, such as procedures, risk management files, and design controls, are in order. Manufacturers should also prepare for the audit schedule and ensure that all relevant staff are available.

4. Schedule the MDSAP Audit

• Action: Once the manufacturer is ready, they can schedule the MDSAP audit with the selected auditing organization. The AO will provide guidance on how to schedule the audit and inform the manufacturer of any specific requirements for the audit.

5. Conduct the MDSAP Audit

• Requirement: The MDSAP audit assesses the manufacturer’s compliance with ISO 13485 and FDA QSR requirements.
• Action: During the audit, the auditor will evaluate the manufacturer’s QMS, including design and development, production processes, risk management, post-market surveillance, and record-keeping. The audit usually lasts 1 to 2 weeks for Class I devices, depending on the scope and complexity of the operation.

6. Address Non-Conformities and Corrective Actions

• Requirement: If the audit identifies any non-conformities, manufacturers must implement corrective actions to address these issues.
• Action: After the audit, the manufacturer will receive a report detailing any findings. The manufacturer must respond to any identified issues by taking corrective actions and submitting evidence of these actions to the auditing organization. This phase can take several weeks to months, depending on the severity of the findings.

7. Obtain MDSAP Certification

• Requirement: Once the corrective actions are completed and the auditing organization is satisfied, the manufacturer will receive the MDSAP certificate.
• Action: The auditing organization will issue the MDSAP certificate, confirming that the manufacturer’s QMS meets the requirements of the participating countries, including the United States. The certificate will be valid for 3 years.

8. FDA Registration and Device Listing

• Requirement: In addition to MDSAP certification, manufacturers must also register their establishment and list their devices with the FDA.
• Action: Manufacturers must complete FDA Establishment Registration and Device Listing through the FDA’s Electronic Registration and Listing System. For Class I devices, FDA registration is typically free, and the listing must be updated regularly.

9. Ongoing Surveillance Audits

• Requirement: After initial certification, manufacturers must undergo surveillance audits to ensure ongoing compliance with MDSAP and the FDA’s requirements.
• Action: Surveillance audits are typically conducted every 1 to 3 years depending on the manufacturer’s risk profile and the auditing organization’s schedule.

Summary of the MDSAP Registration Process for Class I Devices:

1. Establish a compliant QMS (ISO 13485 + FDA QSR).
2. Choose an MDSAP-recognized Auditing Organization (AO).
3. Prepare for the audit by ensuring all processes and documentation are in place.
4. Schedule the MDSAP audit with the chosen AO.
5. Undergo the MDSAP audit, where the QMS and operations are evaluated.
6. Address non-conformities and implement corrective actions if needed.
7. Obtain MDSAP certification once compliance is achieved.
8. Register with the FDA and list devices for market approval.
9. Undergo ongoing surveillance audits to maintain compliance.

Estimated Timeframe for the Process:

• Total Time: The entire process typically takes 4 to 12 months, depending on the manufacturer’s preparedness and the time required for corrective actions after the audit.

By following these steps, manufacturers can successfully register their Class I medical device under the MDSAP system for the U.S. and ensure compliance with FDA regulations and international standards.

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