Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Programme (MDSAP) certification streamlines audits for medical device manufacturers, replacing multiple country-specific audits with a single, comprehensive assessment. Freyr assists companies in meeting MDSAP requirements and obtaining certification, which is mandatory for Canada but optional for Brazil, the United States (US), Japan, and Australia.

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Medical Device Single Audit Program (MDSAP) – Overview

The MDSAP allows medical device manufacturers to undergo a single audit program instead of multiple audits from different countries. It is a global program that furnishes relevant MDSAP requirements for five countries – Brazil (ANVISA), US (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Besides the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP. Freyr assists medical device companies in meeting the standard MDSAP requirements and helps them acquire MDSAP certification.

MDSAP certification is mandated by Health Canada (HC) for Class II, III, and IV devices but is voluntary for the other four (04) countries. It has promoted transparency and Regulatory alignment among participating authorities and minimized the need for multiple audits, thus saving time and resources for medical device manufacturers.

Navigate through the Frequently Asked Questions (FAQs) about the MDSAP program.

The MDSAP audit process is conducted by an Auditing Organization (AO) authorized by the participating Regulatory authorities. The AO conducts an on-site audit of the manufacturer’s Quality Management System (QMS) and evaluates their compliance with the MDSAP requirements. The audit is based on QMS requirements as per ISO 13485:2016 and Regulatory requirements of the participating country where the medical device is marketed.

The MDSAP is based on a three (03)-year audit cycle. The audit cycle comprises the following stages:

  • An initial certification audit that consists of Stage 1 and Stage 2 audits for reviewing the documentation and determining if all ISO 13485 and Regulatory requirements have been met. After the successful completion of Stage 2 audit, the MDSAP certificate is issued by the AO.
  • Partial surveillance audits in each of the following two (02) years.
  • Re-audit or re-certification audit, which is conducted every three (03) years to confirm the continued applicability of the organization’s QMS.

Manufacturers who successfully pass the MDSAP audits will receive a certificate of compliance, which are recognized by the Regulatory authorities of participating countries. Thus, manufacturers can sell their devices in multiple global markets without additional audits. MDSAP certification establishes conformity to country-specific requirements for medical devices. However, the devices still need registration with the respective Health Authorities (HAs) to be placed on the markets.

Freyr’s MDSAP Regulatory consulting services can help you navigate the complex Regulatory landscape and ensure that your medical devices meet the requirements of the MDSAP program. Our team of experts has extensive experience in the medical device industry along with a deep understanding of the MDSAP regulations.

Medical Device Single Audit Program

  • Classification of medical devices.
  • Gap assessment and remediation as per MDSAP requirements.
  • MDSAP documentation support.
  • Pre-audit and post-audit activity support.
  • Mock audit support.
  • Training on applicable MDSAP requirements for the country in scope.
  • Qualified, trained, and experienced team members.
  • Staff augmentation support in QA-RA roles, internal auditors, and trainers.
  • End-to-end support, right from establishing QMS up to carrying out successful product registrations.
  • Global presence to provide on-site support for the implementation of the MDSAP requirements.
  • Vast network of Regulatory experts to cater to the needs of the target markets/customers.