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MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets’ standards and regulatory requirements. The Regulatory Authorities involved with MDSAP are as follows: 

  • Australia: Therapeutics Goods Administration (TGA)
  • Brazil: Brazilian National Health Surveillance Agency (ANVISA)
  • Canada: Health Canada (HC)
  • Japan: The Ministry of Health, Labour and Welfare (MHLW)
  • United Sates: US Food and Drug Administration (USFDA)

Potential Benefits

Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimises the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.

  • As a long-term goal, it is expected that the programme will increase trust in the reliability of third-party audits, that more Regulatory Authorities will join the programme, and that other Regulatory Authorities will use the information made available through the programme to reduce the need for additional audits.
  •  Some participating regulatory agencies may utilize MDSAP audit results instead of their own inspections to process medical device marketing authorization applications.
  • The medical device manufacturer, like any other third-party auditing programme, is free to select any recognised auditing agency to execute the audits. Routine audits are announced and organised in collaboration with the manufacturer.

    • Enhanced auditing organization recognition criteria,
    • Monitoring of auditing organizations by the participating Regulatory Authorities,
    • The use of a standard MDSAP audit model,
    • The grading of any nonconformity using objective criteria to characterize the significance of the finding,
    • The reporting of the audit outcomes using a standard report template.
  • Enrollment in the MDSAP may be seen as proof of a health device manufacturer’s commitment to medical device quality management systems for product quality and regulatory compliance.

Our services are extremely beneficial to medical device makers. Our consultants are knowledgeable and skilled in dealing with the relevant legislation

Maven can help you with the following steps in your MDSAP Certification:

  • Gap Analysis for your existing QMS.
  • If you already have other QMS certifications, for e.g.: ISO 13485, ISO 9001, WHO GMP or 21 CFR 820, experts at Maven can help you prepare an integrated QMS covering the requirements of all the regulatory bodies.
  • Preparing SOPs according to your organization’s requirements.
  • Creation of a quality system required to fulfil regulatory and corporate criteria.
  • Identification of requirements from markets of different countries required for MDSAP Certification and incorporating the same into the QMS.
  • On ground implementation of the Quality Procedures and practices.
  • Mock Audits based on MDSAP’s process-based approach of Auditing.
  • Application for MDSAP with a fully recognized Auditing Organization.
  • Audit support during Initial Certification Audit.

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