Medical Device Single Audit Program (MDSAP)
Streamline Your Global Medical Device Compliance with a Single Audit
Tired of juggling multiple audits for different countries? With the Medical Device Single Audit Program (MDSAP), you can satisfy regulatory requirements for the USA, Canada, Australia, Brazil, and Japan — all through a single, streamlined audit.
At Operon Strategist, we specialize in MDSAP turnkey solutions that take you from compliance gaps to certification with expert guidance every step of the way.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows a single audit to satisfy the quality management system (QMS) requirements of multiple countries. It is recognized by the regulatory authorities of:
- United States (FDA)
- Canada (Health Canada)
- Australia (TGA)
- Brazil (ANVISA)
- Japan (PMDA/MHLW)
MDSAP aligns with ISO 13485:2016 and integrates country-specific regulations, reducing duplicate audits and fast-tracking market access.
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MDSAP was developed to achieve three primary goals:
- Reduce the interruptions to the audit: Assure appropriate regulatory control of manufacturers’ quality management systems while minimizing the need for repeated audits.
- Boost the effectiveness of regulations: Encourage cooperation and acceptability among participating nations while maintaining each authority’s independence.
- Align international norms: Encourage the synchronization of technical specifications and regulatory strategies using global best practices and standards.
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:
- Unified Audit Process: Fulfill several regulatory requirements with a single audit.
- Streamlined Operations: Fewer interruptions and predictable audit timelines.
- Improved Market Access: Made it easier to enter several markets and made it easier for patients to obtain equipment.
- Resource Optimization: Make efficient use of regulatory resources.
- Cost-effectiveness: Reduced audit costs in comparison to independent, stand-alone audits.
- Transparency: Increased accountability and clarity across the sector.
- Integration with ISO 13485: Provides total compliance by covering both regional regulatory needs and ISO 13485.
MDSAP and ISO 13485: What’s the Difference?
| Feature | ISO 13485 | MDSAP |
|---|---|---|
| Scope | QMS for medical devices | QMS + Country-specific regulations |
| Recognition | Global | USA, Canada, Australia, Brazil, Japan |
| Mandatory in Canada | ❌ | ✅ |
| Audit Complexity | Moderate | High – multi-agency audit |
| Integration | Base standard | Includes ISO 13485 + regulatory requirements |
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.
FAQs
What countries require MDSAP?
Make use of the MDSAP if you are a manufacturer of medical devices. In this special programme for medical devices, which includes the US, Canada, Brazil, Australia, and Japan, you can submit for a single evaluation of your quality management system (QMS).
What is the objective of MDSAP?
It is a regulatory auditing programme that four countries initially created cooperatively. MDSAP is exceptional in that it enables a medical device maker to conduct a single quality management system audit to meet the standards of all involved regulatory authorities.
Does MDSAP require ISO 13485?
Manufacturers of medical devices classified as Class II, III, and IV must demonstrate compliance with ISO 13485 under MDSAP.