The MDSAP (Medical Device Single Audit Program) is an international initiative that allows medical device manufacturers to undergo a single audit to satisfy the regulatory requirements of multiple countries, including the United States. While MDSAP itself is not a requirement for FDA registration, it can streamline the process of demonstrating compliance with the FDA's Quality System Regulation (QSR), which is part of the FDA's regulatory framework for medical devices.

Here's the general process for obtaining MDSAP registration in the United States:

1. Eligibility and Preparation:

• Determine Eligibility: Manufacturers must first determine if their device is subject to the FDA's QSR and whether they wish to participate in MDSAP. This typically applies to Class II and Class III devices, but can also be relevant for certain Class I devices, depending on their risk profile.
• Quality Management System (QMS): Before starting the MDSAP process, the manufacturer should have an established QMS that complies with FDA requirements under 21 CFR Part 820 (QSR), as well as the requirements of the other MDSAP participating countries (Canada, Japan, Brazil, Australia).

2. Select an MDSAP Auditing Organization:

• The manufacturer must select an MDSAP-recognized auditing organization. These are third-party, independent organizations authorized to conduct audits for MDSAP.
• The FDA recognizes several organizations to conduct these audits, such as TÜV SÜD, BSI, and others.

3. Audit Process:

• The MDSAP audit is a comprehensive assessment of the manufacturer’s QMS and is conducted by the selected third-party auditing organization.
• During the audit, the auditor reviews the manufacturer’s processes to ensure compliance with the regulatory requirements of the participating countries, including the FDA's QSR.
  • FDA Requirements: Compliance with the FDA’s 21 CFR Part 820 regulations.
  • Other Countries: Compliance with the regulations of Canada, Brazil, Japan, and Australia.
• The audit typically includes:
  • A review of the manufacturer’s processes and documentation.
  • Interviews with personnel.
  • Inspections of facilities and records.
  • Product testing and evaluation.

4. Audit Outcome:

• After the audit, the auditing organization will issue a report detailing the findings. If the manufacturer is compliant, they will receive an MDSAP certificate that confirms their QMS meets the regulatory requirements of all the participating countries.
• If there are any non-conformities or issues found during the audit, the manufacturer must address them and undergo a re-audit or corrective action process to bring the QMS into compliance.

5. Use of MDSAP Certificate for FDA Registration:

• MDSAP certification can be used as evidence that a manufacturer’s QMS complies with the FDA’s QSR, which is part of the medical device registration process in the U.S.
• While the FDA does not mandate MDSAP, having an MDSAP certificate can facilitate the FDA's inspection process and may help avoid or streamline FDA inspections.
• The manufacturer can use the MDSAP certificate to show that they have met the requirements for quality management systems, which can be an important part of FDA registration or approval, especially for Class II and Class III devices.

6. Post-Audit Surveillance:

• After MDSAP certification, the manufacturer must continue to comply with the ongoing surveillance requirements, which include regular audits to ensure continued compliance with QMS regulations.
• If there are significant changes to the device or the QMS, manufacturers may need to undergo additional audits or re-certifications.

Summary of the MDSAP Registration Process for the U.S.:

1. Prepare your QMS: Ensure compliance with FDA’s QSR (21 CFR Part 820).
2. Select an MDSAP-recognized auditor.
3. Undergo the MDSAP audit to evaluate QMS compliance with FDA and other countries' regulations.
4. Receive MDSAP certificate upon successful audit.
5. Use MDSAP certification to demonstrate compliance with FDA requirements for medical device registration or approval.
6. Ongoing surveillance to maintain certification.

Key Benefits of MDSAP for U.S. Registration:

• Streamlines the process by satisfying the FDA's quality system inspection requirements.
• Reduces the number of inspections needed for manufacturers exporting to multiple countries.
• Improves the efficiency and consistency of audits across international markets.

While MDSAP is not mandatory for all devices, it is a valuable tool for manufacturers wishing to demonstrate their compliance with international standards and ease the regulatory burden for medical device registration in the U.S. and other countries.

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