+91 9409299368
contact@tacitmedtek.com
500+ Clients
20+ Years Experience
CDSCO Experts
Pan India Support
Book Consultation
ISO Certification

Quick Snapshot

  • Who Can Apply?
    • Medical Device Manufacturers
    • IVD Manufacturers
    • Contract Manufacturers
    • Organizations exporting to MDSAP participating countries
  • Services Covered
    • MDSAP Gap Assessment
    • Audit Readiness Support
    • Documentation Review
    • Internal Audit Support
    • CAPA Support
  • Participating Markets
    • Canada
    • United States
    • Australia
    • Brazil
    • Japan

What is MDSAP

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single quality management system audit that is recognized by multiple regulatory authorities. This helps companies reduce duplicate audits while demonstrating compliance with regulatory requirements in participating countries.

Currently, MDSAP is recognized by Australia, Brazil, Canada, Japan, and the United States. The program is based on ISO 13485 along with country-specific regulatory requirements.

When Do You Need MDSAP Support?

Practical support for medical device organizations preparing for MDSAP audits, strengthening their quality systems, and maintaining compliance across multiple regulatory markets.

When Do You Need MDSAP Support?
  • Planning to enter Canada, Australia, Brazil, Japan, or the United States
  • Applying for an MDSAP audit for the first time
  • Preparing for a surveillance or recertification audit
  • Transitioning from ISO 13485 certification to MDSAP
  • Addressing gaps identified during internal or external audits
Key Challenges in MDSAP
  • Understanding MDSAP-specific audit requirements
  • Aligning quality systems with multiple regulatory jurisdictions
  • Preparing process-based evidence for audits
  • Managing documentation and records across departments
  • Identifying gaps against MDSAP audit tasks
  • Handling audit observations and corrective actions
  • Maintaining ongoing compliance after certification

Our Approach to MDSAP Readiness & Audit Support

Practical preparation and structured support to help organizations strengthen their quality systems and prepare confidently for MDSAP audits.

Our Approach
  • Review of existing quality management systems
  • MDSAP gap assessment against applicable audit requirements
  • Documentation review and improvement in line with MDSAP expectations
  • Internal audit and audit-readiness support
  • Guidance on CAPA and remediation activities
  • Support in addressing audit observations
What You Will Get (Deliverables)
  • MDSAP Gap Assessment Report and improvement plan
  • Audit Readiness Assessment Report
  • SOP and QMS documentation review
  • Internal audit reports
  • Audit-readiness support
  • Guidance for closure of audit findings

Why Choose Tacit Medtek and Case Example

Practical, end-to-end support for strengthening medical device quality systems, preparing for MDSAP audits, and supporting international market expansion.

Why Choose Tacit Medtek
  • Practical understanding of ISO 13485 and MDSAP requirements
  • Experience with medical device quality systems and regulatory compliance
  • Hands-on support for documentation and audit preparation
  • Focus on practical implementation, not just paperwork
  • Support for startups, SMEs, and established manufacturers
  • Assistance from gap assessment through audit readiness
Case Example
  • Challenge: A medical device manufacturer planning expansion into Canada and Australia had an ISO 13485-certified quality management system but was unfamiliar with MDSAP-specific audit requirements and documentation expectations.
  • Our Approach: Performed an MDSAP gap assessment; reviewed quality system procedures and records; identified areas requiring additional controls and documentation; conducted mock audit sessions; and supported CAPA implementation and audit-readiness activities.
  • Outcome: The company improved its documentation and quality system processes, addressed identified gaps, and became better prepared for its MDSAP audit and international market expansion plans.
    Canada United States Australia Brazil Japan

FAQ

Frequently Asked Questions

01
What is MDSAP?

MDSAP (Medical Device Single Audit Program) is a program that allows a single audit of a medical device manufacturer's quality management system to satisfy requirements of multiple participating regulatory authorities of Australia, Brazil, Canada, Japan and the United States.

02
Is MDSAP the same as ISO 13485?

No. ISO 13485 is a quality management system standard, while MDSAP includes ISO 13485 requirements together with additional country-specific regulatory requirements.

03
Which countries recognize MDSAP?

MDSAP is recognized by regulatory authorities in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States (US FDA).

04
Do I need ISO 13485 before applying for MDSAP?

ISO 13485 forms the foundation of MDSAP. Organizations generally need an established quality management system aligned with ISO 13485 before pursuing MDSAP certification.

05
Can you conduct an MDSAP gap assessment?

Yes. We can review your existing quality system and identify areas that may require improvement before an MDSAP audit.

06
Do you support internal audits and mock audits?

Yes. We provide internal audit and audit readiness support to help organizations prepare for certification audits.

07
Can you help address audit observations?

Yes. We support preparation of corrective action plans (CAPA) and remediation activities following audit findings.

08
How long does it take to prepare for an MDSAP audit?

The preparation timeline depends on the maturity of your quality management system and the gaps identified during the assessment. Most organizations begin preparation several months before the planned audit.

09
Can startups apply for MDSAP?

Yes. Startups with an established quality management system can prepare for MDSAP as part of their global market expansion strategy.

10
Do you support surveillance and recertification audits?

Yes. We can support organizations with ongoing compliance activities, internal audits, and preparation for surveillance or recertification audits.

Get In Touch

Enquire Now

Send Enquiry

Fill in the form and our team will get back to you shortly.

Your information is secure and will never be shared.

Need Help?

Reach our regulatory experts directly.

+91 9409299368 Call Us
contact@tacitmedtek.com Email Us
bd@tacitmedtek.com Email Us
Send Message

Call Us

WhatsApp

Book Appointment

Google Map