The timeline for MDSAP (Medical Device Single Audit Program) registration for Class II medical devices in the United States depends on several factors, including the complexity of the manufacturer’s operations and the efficiency of the chosen auditing body. Below is a general timeline for the process:

1. Preparation Phase:

• Time Required: 1 to 3 months (depending on the manufacturer’s readiness).
• Activities:
  • Review of quality management systems (QMS) to ensure compliance with MDSAP requirements.
  • Internal audits and preparation of documents and procedures to align with MDSAP standards.
  • Training for staff on MDSAP-specific requirements.
• If the company is not already compliant with ISO 13485 (the international standard for medical device quality management systems), it may take additional time to implement or update the necessary systems.

2. Selecting an Auditing Organization:

• Time Required: 1 to 2 weeks.
• Activities:
  • Choose an accredited MDSAP auditing organization (such as NSF, BSI, TÜV SÜD, etc.).
  • Submit required documentation and schedule the audit.

3. Initial MDSAP Audit:

• Time Required: 1 to 3 weeks for the on-site audit.
• Activities:
  • The audit typically lasts between 3-5 days for Class II devices, depending on the complexity of the device portfolio and manufacturing process.
  • The audit will assess your quality management system (QMS) and ensure it meets the requirements of the MDSAP program, which covers regulatory requirements from multiple countries, including the U.S. FDA, Health Canada, Brazil ANVISA, Japan, and Australia.

4. Audit Report and Corrective Actions (if necessary):

• Time Required: 1 to 2 months (depending on findings).
• Activities:
  • After the audit, the auditing body will issue a report. If any non-conformities are found, the manufacturer must implement corrective actions and submit evidence of compliance.
  • The time required to address non-conformities depends on the severity of the findings and the speed of implementation.

5. MDSAP Certification Issuance:

• Time Required: 2 to 4 weeks after successful completion of corrective actions (if applicable).
• Activities:
  • After any corrective actions have been addressed and verified, the auditing organization will issue the MDSAP certificate, which is valid for 3 years.
  • The manufacturer is then able to market the Class II device in all MDSAP-recognizing countries, including the U.S.

Overall Timeline:

• Initial Certification: From start to finish, the full MDSAP registration process for Class II devices typically takes 3 to 6 months, assuming no significant delays or non-conformities.
• If a manufacturer is already compliant with ISO 13485 and has a robust quality management system in place, the process could be completed more quickly (around 3 months).

Ongoing Surveillance Audits:

• After the initial certification, manufacturers must undergo annual surveillance audits to maintain their MDSAP certification. These audits typically take 1-2 weeks and occur every year during the 3-year certification cycle.

Summary of Timeline for MDSAP Registration for Class II Medical Devices:

1. Preparation: 1 to 3 months.
2. Auditing Organization Selection: 1 to 2 weeks.
3. Initial MDSAP Audit: 1 to 3 weeks.
4. Audit Report & Corrective Actions: 1 to 2 months (if necessary).
5. Certification Issuance: 2 to 4 weeks after corrective actions (if needed).

Overall, manufacturers can expect the full MDSAP registration process to take 3 to 6 months for Class II devices, with ongoing surveillance audits required annually.

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