Medical Device Single Audit Program (MDSAP)
MDSAP (Medical Device Single Audit Program) consultants in the USA specialize in assisting medical device companies in preparing for and navigating the MDSAP audit process. MDSAP is a program that allows the conduct of a single regulatory audit to satisfy the quality management system requirements of multiple regulatory authorities, including the U.S. FDA, Health Canada, TGA (Australia), ANVISA (Brazil), and PMDA (Japan).
Engaging with experienced MDSAP consultants can significantly streamline the process of achieving compliance with multiple regulatory authorities, facilitating a more efficient and unified approach to managing quality management systems for medical device companies operating in multiple markets. Operon Strategist can provide assistance to comply with your medical devices.
What is MDSAP?
MDSAP (Medical Device Single Audit Program) is a regulatory initiative that streamlines the audit process for medical device manufacturers by allowing a single audit to assess compliance with quality standards and regulations in multiple jurisdictions, including Australia, Brazil, Canada, Japan, and the United States. It covers ISO 13485:2016 and respective regulatory requirements, simplifying audits and promoting global regulatory compliance in the medical device industry.
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MDSAP was developed to achieve three primary goals:
- Minimize disruptions to medical device manufacturers from multiple regulatory audits while facilitating appropriate regulatory oversight of the manufacturer’s quality management systems.
- Foster the more efficient use of regulatory resources through work sharing and mutual acceptance across multiple countries while respecting the autonomy of each authority.
- Globally advance a greater alignment of regulatory approaches and technical requirements based on international standards and best practices.
Regulatory Authorities Included in MDSAP:
There are five countries currently participating members of MDSAP.
- Therapeutic Goods Administration of Australia (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- U.S. Food and Drug Administration (FDA)
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There are also MDSAP Official Observers:
- European Union (EU)(EMEA)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
And the MDSAP Affiliate Members are:
- Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
- Singapore’s Health Sciences Authority (HSA)
Canada now makes it mandatory to have MDSAP certification for a manufacturer to sell medical devices commercially in Canada.
What Are the Benefits of MDSAP?
A single audit by Auditing Organizations would:
- Minimize medical device manufacturer disruptions due to multiple regulatory audits
- Provide predictable audit schedules (agenda with opening and completion dates)
- Benefit patient health and patient access with the ease of entry to multiple markets
- Leverage regulatory resources
- Incorporate ISO 13485 assessment
- Requirements, including Australia, Brazil, Canada, Japan, and the US
- Reduction in time and resources dealing with findings from multiple audits
- Reduction in the cost of audits in comparison to independent audits
- Improved transparency in the industry
MDSAP and ISO 13485
MDSAP has more stringent requirements than ISO 13485. ISO 13485 and MDSAP are two different programs with similar requirements. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO 13485 MDSAP standards look to ensure that medical devices are manufactured to strict quality requirements. Companies that participate in the MDSAP program must undergo an audit to ensure compliance with both regulatory and ISO 13485 requirements to profit from the program.
Our Role in MDSAP Certification Process:
- Defining the goals: To start with the first step we discuss with you the company and the benefit of MDSAP certification. You will receive a specific offer tailored to the need of your company or organization
- Project planning: project planning is the step where we do a pre-audit, which helps us to identify the improvement potential of QMS in advance. This pre-audit meeting helps us in planning and scheduling audit procedures.
- QMS Quality Management System Assessment: while assessing this step we guide and provide training to our clients to implement QMS as per the required regulations and we also help them in the creation of documents.
- System evaluation: You acquire your MDSAP certificate if all requirements are satisfied and the assessor’s recommendation for certification is confirmed.
The cost for the MDSAP certification depends on the country-specific requirements that need to be assessed during the audit. Feel free to contact us for more details.