To apply for MDSAP (Medical Device Single Audit Program) registration for a Class I medical device in the United States, manufacturers need to follow a structured process that involves several key steps. Below is a step-by-step guide on how to apply for MDSAP registration:

1. Establish a Compliant Quality Management System (QMS)

• Action: Before applying for MDSAP registration, manufacturers must have a Quality Management System (QMS) in place that complies with ISO 13485 and the FDA Quality System Regulation (QSR) (21 CFR Part 820). The QMS should include documented procedures for design controls, manufacturing, packaging, labeling, post-market surveillance, and corrective actions.
• Considerations: Ensure that the QMS covers all necessary components and meets both international (ISO 13485) and U.S. (FDA QSR) requirements.

2. Obtain ISO 13485 Certification

• Action: The manufacturer must be certified to ISO 13485 by an accredited certification body. ISO 13485 certification demonstrates that the manufacturer’s QMS meets international standards for medical device quality management.
• Considerations: This certification is a prerequisite for MDSAP, as the MDSAP audit will assess the QMS against ISO 13485 and FDA QSR requirements.

3. Choose an MDSAP-Recognized Auditing Organization (AO)

• Action: Select an MDSAP-recognized Auditing Organization (AO). These organizations are authorized to conduct MDSAP audits and issue the MDSAP certification. Common AOs include SGS, BSI, TÜV SÜD, and Intertek.
• Considerations: Make sure the AO is accredited to perform audits for the MDSAP program, as only recognized AOs can conduct the audit and issue certification.

4. Schedule the MDSAP Audit

• Action: Once the QMS is ready and ISO 13485 certification has been obtained, contact the chosen AO to schedule the MDSAP audit. The AO will provide information on audit scheduling, fees, and other requirements.
• Considerations: The audit will assess the manufacturer’s compliance with ISO 13485 and FDA QSR, so ensure that all necessary documentation is in place and all staff are prepared.

5. Undergo the MDSAP Audit

• Action: The MDSAP audit is conducted by the AO to assess the manufacturer’s QMS. During the audit, the auditor will examine processes such as product design, development, production, labeling, and post-market surveillance. The audit typically lasts 1-2 weeks for Class I devices, depending on the complexity of the manufacturing process and the number of sites involved.
• Considerations: The manufacturer should ensure that all key personnel and relevant documentation are available for the audit.

6. Address Non-Conformities (If Any)

• Action: After the audit, the AO will issue an audit report. If non-conformities are identified, the manufacturer must implement corrective actions. These corrective actions need to be documented and submitted to the AO for review.
• Considerations: The manufacturer must resolve any non-conformities identified during the audit and provide evidence of corrective actions.

7. Obtain the MDSAP Certification

• Action: After successfully addressing any non-conformities and receiving approval from the AO, the manufacturer will be issued an MDSAP certificate. This certificate confirms that the manufacturer’s QMS complies with the requirements of ISO 13485, FDA QSR, and the regulations of other MDSAP participant countries.
• Considerations: The MDSAP certificate is typically valid for 3 years. After that period, surveillance audits will be conducted to ensure ongoing compliance.

8. FDA Registration and Device Listing

• Action: In addition to MDSAP certification, the manufacturer must complete FDA establishment registration and device listing for the Class I device. This step involves submitting the necessary documentation to the FDA through their FDA Unified Registration and Listing System (FURLS).
• Considerations: For Class I medical devices, the FDA does not charge a registration fee, but device listing is still required.

9. Ongoing Surveillance Audits

• Action: After obtaining MDSAP certification, the manufacturer must undergo surveillance audits at regular intervals, usually every 1 to 3 years, to ensure continued compliance with MDSAP requirements.
• Considerations: Surveillance audits are typically less intensive than the initial audit but are essential for maintaining MDSAP certification.

Summary of the Steps to Apply for MDSAP Registration of a Class I Medical Device:

1. Ensure ISO 13485 and FDA QSR Compliance: Set up a compliant Quality Management System.
2. Obtain ISO 13485 Certification: Achieve ISO 13485 certification from an accredited body.
3. Choose an MDSAP-Recognized Auditing Organization (AO): Select and contact an AO to schedule the audit.
4. Schedule the MDSAP Audit: Plan and prepare for the MDSAP audit with the AO.
5. Undergo the MDSAP Audit: The AO assesses your QMS compliance with the required standards.
6. Address Non-Conformities: Implement corrective actions if needed and submit evidence to the AO.
7. Obtain MDSAP Certification: Once compliant, receive your MDSAP certification.
8. Complete FDA Registration and Device Listing: Register your establishment and list your device with the FDA.
9. Undergo Surveillance Audits: Ensure ongoing compliance through periodic audits.

Estimated Timeline:

• Total Timeframe: The process of obtaining MDSAP registration for a Class I medical device typically takes 4 to 12 months, depending on the manufacturer’s preparedness, the time required for corrective actions, and the scheduling of the audit.

By following these steps, manufacturers can successfully apply for MDSAP registration for their Class I medical devices in the United States and gain access to multiple international markets that recognize MDSAP certification.

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