To apply for MDSAP (Medical Device Single Audit Program) registration for medical devices in the United States, manufacturers need to meet several requirements. These requirements ensure that the company’s Quality Management System (QMS) and practices comply with the regulatory standards of all participating countries, including the U.S. (FDA), Canada, Brazil, Japan, and Australia. Here are the key requirements for applying:

1. ISO 13485 Certification

• ISO 13485 is a critical requirement for MDSAP registration. This international standard defines the quality management system requirements for the design and manufacture of medical devices.
• Manufacturers must have an existing ISO 13485-certified QMS that meets the requirements of MDSAP and the regulations of the participating countries.
• If the manufacturer is not yet ISO 13485 certified, they must first implement and maintain a compliant QMS and obtain ISO 13485 certification before applying for MDSAP.

2. Compliance with FDA Regulations (21 CFR Part 820)

• For U.S. market access, manufacturers must comply with the FDA’s 21 CFR Part 820 regulations, which govern medical device quality systems.
• MDSAP audits assess compliance with both ISO 13485 and 21 CFR Part 820. Manufacturers must ensure their QMS adheres to these standards, which include requirements for document controls, risk management, design controls, and post-market surveillance.

3. Selection of an MDSAP-Accredited Auditing Organization

• Manufacturers must choose an MDSAP-accredited auditing organization to conduct the audit. This organization must be recognized by the regulatory authorities of the MDSAP participating countries (including the FDA).
• A list of accredited auditing organizations can be found on the official MDSAP website.

4. Readiness for the Audit

• Manufacturers need to ensure their facility and documentation are fully prepared for the MDSAP audit. This includes:
  • Up-to-date QMS documentation (procedures, records, etc.)
  • Design and manufacturing records for all medical devices in scope
  • Post-market surveillance and complaint handling records
  • Corrective and preventive action (CAPA) processes
  • Risk management documentation
• The company’s operations, including any suppliers and subcontractors, must also be compliant with MDSAP requirements.

5. Scope of the Devices

• The scope of the MDSAP audit should cover all medical devices that the manufacturer wishes to market in the MDSAP participating countries.
• Manufacturers should clearly define the range of medical devices and their intended markets, as the audit will assess these products' compliance with the relevant regulatory requirements.

6. Continuous Compliance and Surveillance

• Manufacturers must commit to ongoing compliance with the applicable regulatory standards after obtaining MDSAP certification. This includes undergoing annual surveillance audits to maintain certification.
• The manufacturer’s QMS must be maintained and updated regularly to reflect changes in regulations or the company’s operations.

7. Capacity for Corrective Actions

• If nonconformities are found during the MDSAP audit, manufacturers must have the capacity to implement corrective actions and provide evidence of these actions in a timely manner.
• Manufacturers need to address any issues identified by the audit, including changes to their QMS or product processes, and resubmit corrective actions for review if necessary.

8. Fee Payment and Agreement

• Manufacturers will need to pay the audit fees to the chosen auditing organization. These fees vary depending on the size and complexity of the audit but can range from $10,000 to $30,000 or more for the initial audit.
• Manufacturers must sign an agreement with the auditing organization to outline the terms of the audit and certification process.

9. Ongoing Documentation and Reporting

• After the audit, the manufacturer must provide documentation on the results of the audit, including corrective actions taken to address any identified issues.
• The manufacturer will receive a report from the auditing organization, which includes findings and recommendations. If nonconformities are identified, corrective actions must be implemented before the MDSAP certificate is granted.

Summary of Requirements for MDSAP Registration in the U.S.:

1. ISO 13485 certification compliant with MDSAP.
2. Compliance with FDA regulations (21 CFR Part 820).
3. Selection of an MDSAP-accredited auditing organization.
4. Readiness for audit with up-to-date QMS documentation and processes.
5. Clear scope of devices to be audited.
6. Ability to implement corrective actions and continuous compliance.
7. Fee payment to the auditing organization.
8. Ongoing surveillance and annual audits.

By meeting these requirements, manufacturers can apply for MDSAP registration, which will help streamline the regulatory process for medical devices in the U.S. and other participating countries.

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