The cost of MDSAP registration for a Class I medical device in the United States can vary depending on several factors, including the device type, the manufacturer's location, and the specific auditing organization (AO) performing the MDSAP audit. However, I can provide a general breakdown of the potential costs involved:

1. MDSAP Audit Fees

• Audit Fees: The MDSAP audit itself typically costs between $10,000 to $20,000 USD for a Class I device, depending on factors such as the complexity of the device and the manufacturing processes. The cost can be higher if additional audits are needed or if the manufacturer has multiple locations.
• Audit Duration: Class I devices are generally less complex and may require less time for the audit compared to Class II or Class III devices, which may lower the overall audit fees.

2. FDA Registration and Listing Fees

• FDA Establishment Registration: For Class I devices, FDA registration is generally free. Manufacturers still need to register their establishment and list their devices with the FDA, but there are no associated fees for Class I devices.
• Device Listing: Similarly, the listing of a Class I device with the FDA is also free.

3. Other Associated Costs

• Consulting Fees: If the manufacturer requires assistance with preparing for the MDSAP audit or improving their quality management system (QMS), additional costs for consulting services could be incurred. Consulting fees can vary widely, but they may range from $5,000 to $15,000 USD depending on the scope of the work.
• Quality Management System (QMS) Setup: If the manufacturer does not already have a compliant QMS (such as ISO 13485 or FDA QSR), implementing a QMS to meet MDSAP requirements could incur additional costs. QMS setup costs may vary widely depending on the size and complexity of the company but could be anywhere from $10,000 to $30,000 USD.
• Corrective Actions: If non-conformities are found during the audit, corrective actions or system improvements may be needed, which could incur additional costs depending on the nature of the issues found.

4. Ongoing Costs

• Surveillance Audits: After initial registration, MDSAP requires periodic surveillance audits to ensure continued compliance. These audits generally cost between $5,000 to $15,000 USD annually.
• Internal Audits: Manufacturers are also required to conduct their own internal audits to maintain compliance, which can involve costs for internal resources or external consultants.

Estimated Total Cost Range for Class I MDSAP Registration:

• Audit Fee: $10,000 to $20,000
• FDA Registration: Free
• Consulting/Training/Remediation: $5,000 to $15,000 (if needed)
• Ongoing Surveillance: $5,000 to $15,000 per year

Total Estimated Cost for Class I Device Registration:

• The total cost for MDSAP registration for a Class I medical device can generally range between $10,000 and $30,000 USD for the initial registration, with additional ongoing costs for surveillance and maintenance.

For a more precise estimate, it's advisable to contact an MDSAP-recognized auditing organization or regulatory consultant based on the specific device and manufacturer needs.

Contact Us：

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