The priority of MDSAP (Medical Device Single Audit Program) registration for medical devices in the United States depends on several factors related to regulatory compliance, market access, and business strategy. Here are the main considerations:

1. FDA Regulatory Requirements:

   • While MDSAP is not mandatory for all medical device manufacturers selling in the U.S., it is highly advantageous for companies that wish to streamline their compliance process. For U.S. market access, manufacturers must comply with FDA regulations (such as 21 CFR Part 820), but MDSAP certification covers this requirement as part of the audit.

2. Streamlining Audits Across Multiple Countries:

   • MDSAP is particularly beneficial for companies that wish to market their devices in multiple countries, as it allows manufacturers to undergo a single audit that satisfies the regulatory requirements of the FDA (U.S.), Health Canada, ANVISA (Brazil), the Therapeutic Goods Administration (TGA) in Australia, and Japan's PMDA. This reduces the need for multiple audits and simplifies regulatory submissions in these regions.

3. Competitive Advantage:

   • Having MDSAP certification can enhance a company’s credibility and demonstrate its commitment to quality and regulatory compliance. This can be a competitive advantage, particularly for manufacturers seeking to sell medical devices in multiple global markets.

4. FDA’s Recognition of MDSAP:

   • The U.S. FDA recognizes MDSAP as an equivalent to its own inspections for certain aspects of compliance. While MDSAP audits do not replace FDA inspections, they can reduce the frequency of FDA inspections for manufacturers holding an MDSAP certificate, as long as the audit results are satisfactory.

5. Mandatory for Some Manufacturers:

   • For some manufacturers, MDSAP registration may be required if they intend to market their devices in multiple countries where MDSAP is a recognized standard. For example, MDSAP is mandatory for manufacturers in Canada, and it could also be crucial for market entry in Brazil, Japan, and Australia.

6. FDA Inspection Frequency:

   • Manufacturers with MDSAP certification may experience fewer routine FDA inspections since the FDA will use MDSAP audit reports to assess the company’s compliance. However, if issues are found or there are significant changes, the FDA may still conduct their own inspection.

In summary, MDSAP registration can be prioritized by medical device manufacturers who aim to simplify their regulatory process, access multiple markets, and align with FDA requirements. It is particularly beneficial for manufacturers seeking to expand internationally and improve their global compliance strategy.

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