What is an MDSAP Audit?

What is an MDSAP Audit?

In this week's blog, we're going to discuss what an MDSAP audit is, talking about its purpose, which standard it regulates and what are the benefits of using it. For more information, access our form and our consultants will give you all the necessary support.


The MDSAP audit program (Medical Device Single Audit Program) is a system developed with other health authorities from different countries to facilitate good manufacturing practices, this audit is a way in which medical device manufacturers can be audited to comply with the requirements.

What is the purpose of the MDSAP?

The purpose of the MDSAP audit is to establish effective health regulation, some of which are:

  • Single audit to meet regulatory conditions and generate security in its results;
  • Provide long-term global alignment;
  • Minimize regulatory costs for the industry.

What is the main regulatory standard of the MDSAP?

RE 392/2018 - Recognizes the Single Audit Program for Health Products MDSAP, to support inspection and sanitary inspection actions.

RDC No. 39/2013 (as amended by RDC No. 15/2014), provides for the requirements related to proof of compliance with Good Manufacturing Practices for the purpose of registering Health Products and other provisions.

RE nº 2.347/2015 recognizes the MDSAP Audit provided for in RDC nº 39/2013 and established that the program will be recognized by Anvisa through the publication of an individual normative act.


What are the benefits of using the MDSAP?

The MDSAP program is a way to streamline inspection capabilities in the medical device arena, instead of having multiple health authorities approve the same factory floor plan, only one inspection is done by a third party auditing body. This body being all the authorities that are part of the program.

Many companies have participated in the MDSAP program, for this reason ANVISA can carry out fewer international inspections and act only in situations of greater risk, thus certifying the appropriate use of the invested funds. In addition, the MDSAP program generates greater health safety for health products, and these companies are audited more frequently, due to the sending of annual reports to the Agency and other authorities that are part of the program.


How can we help you?

If you need help with best practice or how to apply for quality system assessment processes, contact Stone Okamont our consultants are all trained and specialists in the field of quality system assurance, contact us I'm sure we can to help you.

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