MS Certification Services

Medical Device Single Audit Program (MDSAP)

Medical Device Single Audit Program (MDSAP)

At AQC, we assist medical device manufacturers in obtaining certification under the Medical Device Single Audit Program (MDSAP), enabling them to comply with regulatory requirements across multiple countries through a single audit process.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo one regulatory audit to satisfy the requirements of multiple participating countries. This reduces the burden of multiple audits and streamlines compliance.

MDSAP Participating Regulatory Authorities:

United States

FDA (Food and Drug Administration)

Canada

Health Canada

Australia

TGA (Therapeutic Goods Administration)

Brazil

ANVISA (Agência Nacional de Vigilância Sanitária)

Japan

MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency)

Mandatory in Canada – Since January 1, 2019, Health Canada requires all Class II, III, and IV medical devices to be certified under MDSAP.

Benefits of MDSAP Certification

Single Audit for Multiple Markets

Reduces the need for multiple audits, saving time and costs

Improved Global Market Access

Ensures compliance with major regulatory authorities

Enhanced Regulatory Oversight

Strengthens quality management system (QMS) compliance

Risk-Based Approach

Focuses on patient safety and regulatory efficiency

Competitive Advantage

Demonstrates high-quality standards to regulators and stakeholders

Our MDSAP Services

MDSAP Readiness Assessment & Gap Analysis

  • Evaluating existing ISO 13485:2016 QMS compliance with MDSAP requirements
  • Identifying gaps and recommending improvements

MDSAP Implementation & Documentation Support

  • Aligning QMS with MDSAP regulatory requirements
  • Developing procedures, policies, and documentation for compliance

Internal Audits & Pre-Certification Support

  • Conducting internal audits to prepare for the official MDSAP audit
  • Assisting with audit preparation and corrective actions

Training & Regulatory Guidance

  • Training teams on MDSAP requirements, regulatory expectations, and audit preparedness

Who Needs MDSAP Certification?

Contract Manufacturers & Suppliers

Medical Device Manufacturers targeting MDSAP-participating countries

Medical Device & IVD Manufacturers

Contract Manufacturers & Suppliers

Distributors & Importers

Distributors & Regulatory Consultants

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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