What is Medical Device Single Audit Program (MDSAP)?

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Medical Device Single Audit Program (MDSAP)

An MDSAP is a type of audit that focuses on the medical device industry. It is a voluntary program that helps companies to improve their quality management systems and comply with international standards. The program is based on ISO 13485.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is an international program that harmonizes the requirements for a quality management system (QMS) audit of medical device manufacturers. The program was developed by the International Medical Device Regulators Forum (IMDRF) in order to streamline the process of QMS audits for companies that manufacture medical devices that are sold in multiple jurisdictions.

The European Union’s Notified Bodies. MDSAP was implemented on January 1, 2016, and the first audits were conducted in 2017. As of 2019, all six participating authorities require MDSAP certification for medical device manufacturers that wish to sell their products in their respective jurisdictions.

What is the difference between ISO 13485 and MDSAP?

There are a few key differences between ISO 13485 and MDSAP.

ISO 13485 is a quality management system standard specific to medical device manufacturers. It is voluntary though encompasses recommended best practices for manufacturers to adopt.

MDSAP is an audit program that aims to streamline regulatory compliance from different countries, such as Australia, Brazil, Canada, Japan, and the US, making it easier for medical device manufacturers. MDSAP registration is required to sell medical devices in these markets.

ISO 13485 is focused on quality management within an organization, while MDSAP takes a more holistic approach to compliance, covering audits, device labeling, and post-market surveillance.

Which country is MDSAP mandatory for?

There are currently five regional market regulators who have adopted MDSAP:

  • Australia’s Therapeutic Goods Administration (TGA)
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Canada’s Health Canada
  • Japan’s Ministry of Health, Labor, and Welfare (MHLW)
  • United States Food and Drug Administration (FDA)

At present, the Medical Device Single Audit Program is only mandatory for Australia, Brazil, Canada, and Japan.

What is the audit cycle of MDSAP?

The MDSAP audit cycle consists of four phases:

  1. Pre-audit phase: In this phase, the auditor will review the manufacturer’s quality management system (QMS) documentation to assess compliance with the requirements of the MDSAP.
  2. Initial audit phase: This phase includes an on-site assessment of the manufacturer’s QMS by the auditor. During this phase, the auditor will interview key personnel and observe operations to determine compliance with MDSAP requirements.
  3. Surveillance audit phase: In this phase, the auditor will conduct periodic reviews of the manufacturer’s QMS to ensure continued compliance with MDSAP requirements. These reviews may be conducted on-site or remotely, depending on the agreement between the manufacturer and the auditing organization.
  4. Close-out audit phase: This final phase of the audit cycle includes a review of any corrective actions taken by the manufacturer in response to findings from previous phases of the audit. Once all corrective actions have been satisfactorily addressed, the auditor will issue a certificate of compliance to the manufacturer indicating the successful completion of the MDSAP audit cycle.

About Us

Pro QC is a leading Global Quality Assurance company that has been operating in the Medical Devices industry for over 40 years. With our solutions, we cover the entire quality assurance spectrum. Among our services are MDSAP audits, ISO 13485 audits, ISO 9001 audits, ISO 13485 audits, supplier verifications, supplier management, quality inspections and many more. Contact us at info@proqc.com.



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