MDSAP Compliance
The Medical Device Single Audit Program (MDSAP) offer significant benefits for device manufacturers: Saving valuable time, reducing cost, and increasing efficiency.
MDSAP Compliance
The QNR team has years of experience supporting MDSAP compliance activities throughout its life cycle.
The Medical Device Single Audit Program (MDSAP) has become increasingly popular among device manufacturers for the benefits it offers. MDSAP compliance allows the manufacturer's MDSAP-accredited certification body to complete an assessment on behalf of the 5 MDSAP participating countries, consolidating the requirements of 5 different countries into a single review.
Investing in MDSAP certification can save time and money. Depending on market, MDSAP certification offers the following:
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Eliminates the need for routine agency inspections;
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Shortens the review process and/or expedites approvals for easier, faster entry into markets;
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Allows market entry in countries where MDSAP compliance is a requirement.
The MDSAP 5: The Details
MDSAP and Market Access:
The Participating Member Countries
Below are the current MDSAP participating countries:
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United States (FDA):
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Canada (Health Canada):
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Australia (TGA);
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Brazil (ANVISA, INMETRO);
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Japan (MHLW, PMDA)
The QNR team has many years of experience supporting MDSAP related activities, and can support your business as needed throughout each stage of the project.
RA support for MDSAP is full scope and may include the following activities based on business need:
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Global strategy preparation, assessment, and execution;
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Audit preparedness and support;
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Collaboration with in-country affiliates for document preparation and submission;
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Working directly with in-country agencies and certification bodies for license and/or certificate approval.
In summary, MDSAP certification has great benefits to manufacturers, and the QNR team can support your MDSAP activities from start to certificate (and beyond).