MDSAP

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a global initiative that allows medical device manufacturers to undergo a single regulatory audit of their Quality Management System (QMS), satisfying the requirements of multiple regulatory authorities. Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP enables third-party auditors to assess compliance with ISO 13485:2016 and country-specific regulations in one streamlined process.

Instead of preparing for multiple audits, manufacturers can demonstrate compliance through one MDSAP audit, gaining access to five major medical device markets.

Regulatory Authorities Covered under MDSAP

MDSAP provides recognition across leading international markets:

  • Australia – Therapeutic Goods Administration (TGA)

  • Brazil – Agência Nacional de Vigilância Sanitária (ANVISA)

  • Canada – Health Canada

  • Japan – Ministry of Health, Labour and Welfare (MHLW) & Pharmaceuticals and Medical Devices Agency (PMDA)

  • United States – Food and Drug Administration (FDA)

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Benefits of MDSAP Certification

MDSAP certification offers significant advantages for manufacturers:

  • Global market access through a single audit

  • Reduced duplication of audits and inspections

  • Greater efficiency in compliance management

  • Transparent and predictable audit outcomes

  • Strengthened regulatory confidence and reputation

  • A structured and reliable audit schedule

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MDSAP vs. ISO 13485

While ISO 13485 sets the foundation for QMS compliance, MDSAP combines these requirements with additional country-specific regulations. This makes MDSAP more comprehensive and valuable for companies aiming for global recognition.

  • ISO 13485 focuses solely on QMS requirements.

  • MDSAP integrates ISO 13485 with regulatory compliance across multiple countries.

For manufacturers, this means one certification process that ensures both quality and global regulatory acceptance.

How Operon Strategist Supports the MDSAP Certification Process?

Step 1: Defining Goals

We begin by understanding your business objectives and explaining the full scope of MDSAP certification. Based on your needs, we design a tailored roadmap for your organization.


Step 2: Project Planning and Pre-Audit

Our experts conduct a pre-audit assessment to identify compliance gaps within your QMS. This helps us build a clear project plan and prepare for the final certification audit.


Step 3: QMS Implementation and Documentation

We guide you in implementing and aligning your Quality Management System with MDSAP and ISO 13485 requirements. Our team assists in preparing documentation, training your staff, and strengthening compliance.


Step 4: System Evaluation and Certification

Once requirements are met, we support you throughout the certification audit process until your MDSAP certificate is successfully obtained.

The overall cost of MDSAP certification depends on the country-specific regulations being assessed, and we help optimize the process to make it efficient and cost-effective.

Why Choose Operon Strategist for MDSAP?

  • Specialized expertise in global regulatory consulting

  • Proven experience across multiple regions including India, South Africa, Egypt, USA, UK, Costa Rica, Oman, and Iran

  • Customized solutions for every manufacturer’s needs

  • Strong focus on timely certification and market entry

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FAQ'S

What is MDSAP certification for medical devices?

It’s a single audit covering regulatory requirements of countries like the USA, Canada, Australia, Brazil, and Japan.

Is MDSAP certification mandatory in Egypt?

No, it’s optional but recommended for exports to MDSAP-participating countries.

Which countries accept MDSAP certification?

USA, Canada, Australia, Brazil, and Japan officially recognize it.

How can Operon Strategist help with MDSAP in Egypt?

We provide consulting, documentation, gap analysis, and audit readiness support for MDSAP certification.

What are the benefits of MDSAP certification?

It reduces multiple audits, eases global market entry, and boosts QMS credibility.