The Medical Device Single Audit Program (MDSAP) provides a comprehensive framework for conducting a single, integrated audit that meets the requirements of regulatory authorities in the United States, Canada, Brazil, Japan, and Australia. MDSAP supports the standardization of audit processes, facilitates active monitoring of quality management systems, and helps in obtaining the CE mark. This global approach to auditing and oversight of medical device manufacturing aims to enhance safety and regulatory compliance on an international scale.

What is the Medical Device Single Audit Program (MDSAP)?

MDSAP is an innovative program that enables a single, integrated audit of the quality management system of a medical device manufacturer. Thanks to MDSAP, one audit meets the regulatory requirements of five regions: the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW and PMDA), and Australia (TGA). MDSAP facilitates the certification process and increases the operational efficiency of companies producing medical devices.

How is MDSAP Implemented?

The implementation of MDSAP occurs in several stages:

1. Application: The medical device manufacturer applies to notified body to prepare an offer.
2. Audit Planning: Dates and audit scope are set according to MDSAP guidelines and specific regulatory requirements of the regions, which means taking into account the specific regulations and laws in the participating countries.
3. Audit Execution: Auditors conduct a comprehensive audit of the quality management system, assessing compliance with the regulatory requirements of the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW and PMDA), and Australia (TGA).
4. Reporting: Audit results are reported to the respective regulatory bodies, such as:

  • FDA (USA)
  • Health Canada (Canada)
  • ANVISA (Brazil)
  • MHLW and PMDA (Japan)
  • TGA (Australia) These bodies recognize MDSAP reports as the basis for making compliance and certification decisions.

5. Corrective Actions: If non-compliances are identified, the manufacturer must implement appropriate corrective actions, which are monitored.
6. Surveillance Audits: Regular surveillance audits are conducted to ensure that the quality management system is maintained at a compliant level. These audits usually take place annually.
7. Recertification: Every three years, a full recertification audit is conducted to ensure continuous compliance of the quality management system with MDSAP requirements and the respective regions.  

Frequently Asked Questions (FAQ)

1. Which countries recognize MDSAP audits?

MDSAP audits are recognized by the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW and PMDA), and Australia (TGA).

2. Does MDSAP replace other certifications?

Yes, MDSAP can replace many individual regulatory audits, including:

  • FDA (USA): Audit for compliance with FDA requirements for medical devices.
  • Health Canada (Canada): Audit for compliance with Canadian regulatory requirements.
  • ANVISA (Brazil): Audit for compliance with Brazilian requirements for medical devices.
  • MHLW and PMDA (Japan): Audit for compliance with Japanese regulatory requirements.
  • TGA (Australia): Audit for compliance with Australian requirements for medical devices.

3. Can an MDSAP audit help in obtaining the CE mark?

Yes, an MDSAP audit can help in obtaining the CE mark. While MDSAP is not directly recognized by the European Union, conducting an MDSAP audit can facilitate the CE marking process by ensuring compliance with international quality management standards.

4. What are the connections and differences between MDSAP and ISO 13485?

Connections between MDSAP and ISO 13485:

  • Similar Goals: Both MDSAP and ISO 13485 aim to ensure that the quality management system of a medical device manufacturer is compliant with regulatory requirements and leads to safe and effective products.
  • Quality Management: Both systems focus on quality management, including aspects such as risk management, management responsibility, resource management, product realization, data analysis, and continuous improvement.

Differences between MDSAP and ISO 13485:

  • Audit Scope: MDSAP includes an audit for compliance with regulatory requirements of different regions, while ISO 13485 focuses on international quality management standards.
  • Reporting: MDSAP audit results are reported to multiple regulatory bodies, allowing for approvals from several regions simultaneously. ISO 13485 requires separate audits and certifications for each market.
  • Global Recognition: MDSAP is recognized by specific regulatory bodies (USA, Canada, Brazil, Japan, Australia), while ISO 13485 is recognized worldwide but requires separate certifications for individual markets.