The importance of MDSAP

The MDSAP (Medical Device Single Audit Program) is a program that allows a single audit of the Quality Management System, following the ISO 13485:2016 standard, of a medical device manufacturer that meets the requirements from various Regulatory Authorities.

Audits are conducted by Audit Organizations authorized by participating Regulatory Authorities to audit following MDSAP requirements.

What is the purpose of the MDSAP?

 

Promote more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators, respecting the sovereignty of each authority;

Promote globally, in the long term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;

Promote consistency, predictability, and transparency of regulatory programs through standardization; participating regulators’ practices and procedures for oversight of third-party audit organizations and the audit practices and procedures of participating third-party organizations;

Leverage, where appropriate, existing requirements and procedures for assessing compliance.

Who are the Regulatory Authorities?

Australia: Therapeutic Goods Administration of Australia

Brazil: Anvisa – Brazilian Health Regulatory Agency

Canada: Health Canada

Japan: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

United States: U.S. Food and Drug Administration

What are the benefits of MDSAP?

A single audit replaces multiple audits conducted by different regulatory authorities,

Reduction of the number of audits or inspections received, optimizing the time and resources dedicated to these activities,

As a long-term objective, the program is expected to increase safety and confidence so that other regulatory authorities participate in the program and limit the need for additional audits.

MDSAP can significantly reduce the waiting time for completing a certification process required by a Regulatory Authority, considering that the deadline for conducting MDSAP audits is agreed upon between the manufacturer/requester and the Auditing Organization.

The program will allow permanent monitoring of the consistency of the companies’ quality systems.

  How does it work?

– Request the MDSAP form for NCC Certificações;

– Send the completed form informing the markets for which you want to use the MDSAP program;

– NCC will access the information and establish the number of audit days following the MDSAP rules, and the proposal will be sent;

– After starting the process, NCC will request some documents from the Quality Systems for step 1. If the documents are accepted, the audit will be scheduled;

– NCC will conduct the audit, and, upon verification of compliance with the MDSAP requirements, the certificate will be issued;

– The company will use this certificate for the markets included in the audit, following the form completed by the customer;

– Every year, the factory will undergo a maintenance audit;

– It is possible to add another market after issuing the certificate by adapting the process.  

Guisla Martins and Wilson Bonato Source: www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-documents