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What Is MDSAP ?

by | Jul 25, 2023

Integrated medical equipment audit program :The “Integrated Medical Device Audit Program” process, abbreviated as MDSAP, has been designed and developed to ensure that all medical device requirements are audited with a single audit.

What is MDSAP?

MDSAP is an international audit program based on a model designed by the International Association of Medical Device Regulators (IMDRF) with the participation of relevant regulatory bodies from five countries: the United States Food and Drug Administration (FDA), the Canadian Ministry of Health, the Australian Ministry of Health (TGA), the Brazilian Ministry of Health (ANVISA) and the Japanese Ministry of Health (MHLW). The United States leads the way in the number of MDSAP certifications, but the past year has seen steady adoption in markets such as Brazil. The European Union is currently working out the details of implementing the MDSAP among its member states and has not yet joined.

What is the MDSAP audit sequence?

The MDSAP audit sequence was designed and developed to enable audits to be conducted in a logical, focused and efficient manner. The MDSAP audit sequence follows a process approach and has four core processes and one support process. These processes include the following:

(1) Management

(2) measure, analyze and improve;

(3) design and development

(4) production and service controls and

(5) Purchase

The definition of each process includes a goal and a result, which are process performance indicators. These five processes are based on risk management requirements and include the requirements of the quality management system for medical device manufacturers according to ISO 13485:2016. The MDSAP audit process has two additional supporting processes:

(1) the process of obtaining authorization for the marketing of medical devices and

(2) Medical device accident reports and advisory warnings issued by the manufacturer.

These processes are necessary to meet the specific requirements of participating MDSAP regulatory authorities.

Designing and implementing an organization’s quality management system is a strategic decision based on the needs of the organization, the size of the organization, the processes used, and the products offered. If the organization does not perform certain processes (for example, design and development), the organization’s quality management system does not need to establish such a requirement, and the relevant process does not need to be audited. However, if the organization decides to outsource processes related to the design and/or manufacturing of medical devices for which the organization is responsible, these processes remain the responsibility of the organization and must be addressed in the organization’s quality management system through monitoring and maintenance. Similarly, in addition, the organization may waive requirements for markets to which it does not intend to supply the product. For example, the organization decides not to export its medical equipment to the American market; As a result, there is no need to implement the requirements of the United States and the FDA in your company.

This program is supposed to cover the set of requirements of the member states which include the following laws:

  • Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3),
  • Brazilian Good Manufacturing Practices (RDC ANVISA16/2013),
  • Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169),
  • Quality System Regulation (21 CFR Part 820).

Currently, manufacturers of laboratory medical equipment who intend to export to several member countries of the MDSAP program can pass all the requirements of the member countries with a single audit and export to all these countries without any worries. Quality Development Company provides the possibility for manufacturers to easily obtain the mentioned certificate by examining and studying in depth in the field of “integrated medical equipment audit program”.