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The cost of MDSAP (Medical Device Single Audit Program) registration for Class II medical devices in the United States can vary depending on several factors, including the certification body you choose and the complexity of the audit. MDSAP is a global audit program recognized by multiple regulatory authorities, including the FDA, and it allows manufacturers to satisfy the regulatory requirements of several countries through a single audit.

Key Cost Factors for MDSAP Registration:

1. Certification Body Fees:

   • The cost of MDSAP certification is primarily driven by the fees charged by the recognized MDSAP Auditing Organizations (such as NSF, BSI, TüV SüD, etc.).
   • Initial Audit Fees: These can range from $10,000 to $30,000 or more, depending on the complexity of your facility, the number of sites, and the device types being certified.
   • Surveillance Audits: After the initial audit, annual surveillance audits are required to maintain MDSAP certification. These typically cost between $5,000 to $15,000 per year, depending on the scope of the audit and the certification body.

2. Audit Duration and Complexity:

   • The size and complexity of your manufacturing process can affect the overall cost. For example, if you have multiple sites or a complex device portfolio, the audit may take longer, resulting in higher costs.

3. Additional Costs:

   • Travel and Expenses: Some auditing bodies may charge for travel expenses if the audit requires on-site visits.
   • Consultation Fees: If you choose to hire a consultant to help prepare for the audit, this will incur additional costs. Consultants typically charge $100 to $300 per hour depending on their experience and services provided.

4. MDSAP Registration Fees (FDA):

   • The FDA does not charge a separate fee for MDSAP registration, as the program is designed to streamline the auditing process for manufacturers. The primary costs are those associated with the auditing bodies.

Estimated Total Cost for MDSAP Registration:

• Initial Audit Cost: Around $10,000 to $30,000.
• Annual Surveillance Audits: Around $5,000 to $15,000 per year.
• Additional Fees: Travel, consultation, and other miscellaneous costs could add up, depending on the specific needs of the manufacturer.

Summary:

The total cost for MDSAP registration for a Class II medical device manufacturer in the U.S. typically ranges from $10,000 to $30,000 for the initial certification audit, with ongoing annual costs for surveillance audits ranging from $5,000 to $15,000 per year. These costs can vary based on the complexity of your operations and the certification body you choose

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