The Medical Device Single Audit Program (MDSAP) is a program that allows medical device manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple regulatory authorities. The MDSAP is a collaborative effort among several countries, including the United States (FDA), Canada (Health Canada), Australia (Therapeutic Goods Administration), Brazil (Agência Nacional de Vigilância Sanitária), and Japan (Ministry of Health, Labour, and Welfare). Here's an overview of the MDSAP audit process:

1. Preparation:

Scope Determination: Define the scope of the MDSAP audit, including the applicable regulations and the countries in which the medical device will be marketed. Documentation Review: Review and organize relevant documentation to ensure compliance with MDSAP requirements.

2. Selection of Auditing Organization:

Choose an authorized Auditing Organization (AO) accredited by the Regulatory Authorities participating in the MDSAP program. The AO will conduct the audit and assess compliance with the relevant regulations.

3. Audit Planning:

Develop an audit plan that outlines the audit scope, objectives, and schedule. Identify the key areas to be audited, including the quality management system, regulatory compliance, and product-specific requirements.

4. On-Site Audit:

The AO conducts an on-site audit at the medical device manufacturer's facilities. Audit activities may include interviews, document reviews, observation of processes, and verification of compliance with regulatory requirements.

5. Audit Report:

The AO prepares an audit report documenting the findings, observations, and any non-conformities identified during the audit. The report includes recommendations and may require corrective actions from the manufacturer.

6. Corrective Actions:

The medical device manufacturer addresses any identified non-conformities by implementing corrective actions. The manufacturer provides evidence of the corrective actions taken to the AO.

7. Certification Decision:

The AO reviews the corrective actions and determines whether the medical device manufacturer is in compliance with MDSAP requirements. A certification decision is made, and the manufacturer may receive an MDSAP certificate if compliance is demonstrated.

8. Reporting to Regulatory Authorities:

The AO submits the audit report and certification decision to the regulatory authorities involved in the MDSAP program. Regulatory authorities may use the information for regulatory purposes, including marketing authorization and surveillance.

9. Continual Improvement:

The medical device manufacturer should use the audit findings and feedback to drive continual improvement of its quality management system and processes.

10. Surveillance Audits:

Periodic surveillance audits may be conducted by the AO to ensure ongoing compliance with MDSAP requirements. Surveillance audits are typically conducted at agreed-upon intervals.

The MDSAP audit process provides a streamlined approach for medical device manufacturers to demonstrate compliance with multiple regulatory requirements, facilitating international market access. It promotes consistency and efficiency in auditing processes, reduces regulatory burden, and enhances global regulatory cooperation. Manufacturers should work closely with their chosen AO and regulatory authorities to ensure a successful MDSAP audit and certification process.