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MDSAP - Medical Device Single Audit Program Certification

A single scheme to demonstrate compliance.

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to have a single audit of their Quality Management System (QMS) which satisfies the requirements of multiple regulatory jurisdictions.

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Overview

The Medical Device Single Audit Program (MDSAP) was established by the International Medical Device Regulators Forum (IMDRF). The aim of the program is a harmonised approach to auditing and monitoring the manufacturing of medical devices on an international scale to improve medical device safety – which benefits both industry and the end user.

MDSAP allows medical device manufacturers to have a single audit of their Quality Management System (QMS) which satisfies the requirements of multiple regulatory jurisdictions.

MDSAP certification incorporates compliance of a manufacturer’s quality management system to the international standard ISO 13485 and additional regulatory requirements applicable to the countries where the devices are sold.

Regulatory Authorities included in MDSAP

MDSAP allows medical device manufacturers to be audited once for compliance with the standard and regulatory requirements of five different medical device markets. The following five Regulatory Authorities are involved with MDSAP:

  • Australia: The Therapeutics Goods Administration
  • Brazil: The Brazilian National Health Surveillance Agency
  • Canada: Health Canada

It is a requirement that any device which is to be marketed or distributed into Canada (classification dependent) must be MDSAP certified. This replaced the CMDCAS requirements under ISO 13485:2003

  • Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency
  • United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

What are the benefits of MDSAP?

The MDSAP offers multiple benefits to medical device manufacturers including:

  • Minimising disruption from multiple regulatory audits
  • Reduction in the time and cost of audits compared to multiple audits
  • Demonstrates compliance with the requirements of the countries engaged in the programme
  • Improvement of the predictability of audit outcomes through enhanced processes.

Need help with MDSAP?

LRQA offers a range of services to organisations operating within the medical devices industry including accredited ISO 13485 certification and training and we are an Authorised Auditing Organisation for MDSAP certification – all designed to support you to achieve compliance and get the most from your QMS.

Contact us to learn more about MDSAP certification.

Why choose LRQA?

Dedication to assurance

LRQA explores every quality management system process with rigorous, analytical precision to draw accurate conclusions every time.

Technical expertise

LRQA is accredited by United Kingdom Accreditation Service (UKAS) and we are an authorised MDSAP Auditing Organisation for the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency ( ANVISA), the Canadian Health Products and Food Branch (Health Canada, the United States Food and Drug Administration (FDA) and the Japan Ministry of Health, Labour and Welfare and Japanese Pharmaceuticals and Medical Devices Agent (MHLW/PMDA).

Our assessors are industry specialists whom we match with your business needs, enabling an effective audit of your QMS that drives positive short and long-term impacts.

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INSIGHTS

What we think

LRQA's experts regularly share their research and insights.

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