The process for MDSAP (Medical Device Single Audit Program) registration for Class II medical devices in the United States involves several steps, designed to streamline regulatory compliance for manufacturers by integrating the requirements of multiple countries, including the FDA. Here's a breakdown of the key steps:

1. Ensure Compliance with ISO 13485

• What to Do: Before applying for MDSAP registration, your company must have a quality management system (QMS) that complies with ISO 13485:2016, the international standard for medical device quality management systems.
• Why It's Important: ISO 13485 is the foundation of MDSAP audits, as the program assesses the QMS against ISO 13485, as well as regulatory requirements from the FDA, Health Canada, Brazil, Japan, and Australia.

2. Choose an MDSAP Auditing Organization

• What to Do: Select an accredited auditing body from the list of recognized MDSAP Auditing Organizations, such as:
  • NSF International
  • BSI Group
  • TÜV SÜD
  • Intertek
  • UL
• Why It's Important: Only accredited MDSAP auditing organizations can conduct the audit and issue the certification.

3. Submit Application and Schedule Audit

• What to Do: Submit an application to the chosen auditing body, providing the necessary documentation about your device(s), your manufacturing processes, and your existing quality management system.
• Why It's Important: This step is essential to begin the scheduling of the audit and allow the auditing body to review your QMS documentation in advance.

4. Prepare for the MDSAP Audit

• What to Do: Ensure that your QMS is fully in place and that your team is prepared for the audit.
  • Conduct internal audits to verify that your systems meet ISO 13485 and other MDSAP requirements.
  • Review the documentation, processes, and records that will be assessed during the audit.
• Why It's Important: Proper preparation ensures the audit goes smoothly and reduces the chances of non-conformities being identified during the audit.

5. Conduct the MDSAP Audit

• What to Do: The MDSAP audit typically involves a 3- to 5-day on-site inspection of your facility, where auditors will assess your compliance with ISO 13485 and other regulatory requirements, such as:
  • FDA 21 CFR Part 820 (Quality System Regulations)
  • Health Canada’s Medical Device Regulations (MDR)
  • Brazilian ANVISA regulations
  • Japanese Pharmaceutical and Medical Device Agency (PMDA) regulations
  • Australian Therapeutic Goods Administration (TGA) regulations
• Why It's Important: The audit will assess the effectiveness of your QMS in meeting the regulatory requirements of the countries covered by MDSAP, including the U.S. FDA.

6. Receive Audit Report and Address Non-Conformities (if any)

• What to Do: After the audit, the auditing body will issue a report. If any non-conformities are identified, you will need to:
  • Develop and implement corrective actions.
  • Provide evidence of corrective actions taken to resolve non-conformities.
• Why It's Important: Corrective actions are essential to ensure that your QMS meets regulatory standards and to demonstrate your commitment to quality and compliance.

7. Certification Decision

• What to Do: Once the audit is complete and any corrective actions have been verified, the auditing body will issue the MDSAP certification.
• Why It's Important: MDSAP certification allows you to market your Class II medical device in the U.S. and other MDSAP-recognizing countries (Canada, Brazil, Japan, Australia).

8. Ongoing Surveillance Audits

• What to Do: After receiving your MDSAP certification, you will need to undergo annual surveillance audits to ensure continued compliance with the program.
• Why It's Important: Surveillance audits are required to maintain your MDSAP certification and ensure that your quality management system remains in compliance with regulatory requirements.

Summary of MDSAP Registration Process for Class II Medical Devices:

1. Ensure Compliance with ISO 13485: Align your quality management system with ISO 13485.
2. Choose an MDSAP Auditing Organization: Select an accredited auditing body.
3. Submit Application and Schedule Audit: Submit documents and schedule the audit.
4. Prepare for the Audit: Review QMS and prepare your team for the audit.
5. Conduct the Audit: Undergo the on-site MDSAP audit, which evaluates your QMS and regulatory compliance.
6. Address Non-Conformities: If necessary, implement corrective actions and submit evidence.
7. Receive Certification: Once compliance is confirmed, receive your MDSAP certification.
8. Ongoing Surveillance: Undergo annual surveillance audits to maintain certification.

Estimated Timeline:

• Preparation and Documentation Review: 1 to 3 months.
• Audit Scheduling: 1 to 2 months.
• Audit Duration: 3 to 5 days on-site.
• Certification Issuance: 2 to 4 weeks after the audit (pending corrective actions).
• Ongoing Audits: Annually for continued compliance.

Overall, the MDSAP certification process for Class II devices can take around 3 to 6 months for initial certification, depending on the manufacturer's preparation and the complexity of the audit.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn