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Medical Device Single Audit Program (MDSAP)

Way Back in 2012 the International Medical Device Regulatory Forum (IMDRF) Work Group developed a standard called Medical Device Single Audit Program. These are a set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ and their quality management systems.  

The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” [International Medical Device Regulators Forum Medical Devices Single Audit Program, International Coalition Pilot Program sheet, January 2014]

What are the Basics and Benefits of MDSAP Audit:

Basically, this standard is meant to have a comprehensive approach of auditing manufacturers of medical devices for quality management systems and regulatory requirements. This standard is an effort by Food and Drugs Authority of USA (FDA) to reduce regulatory inspection visits to companies making medical devices. This single certification audit instead of duplicating with an ISO audit and another with regulatory audit.

From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.

Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities(Source; https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm)

The benefit to medical device manufacturers is that they can avoid regulatory inspections by having MDSAP certificate.

Is this Certificate Mandatory:

At present FDA has not issued guideline to have this certificate as Mandatory. It is only Voluntary. However, mentions that FDA will accept MDSAP certificate and will not have Mandatory regulation Inspections once a company is certified to this standard.

What is the Link Between MDSAP and ISO 13485:2016:

MDSAP audit includes auditing of all requirements for ISO 13485:2016 in addition to consolidated regulatory requirements of participating countries. Companies have an option to get this one single audit or get ISO 13485 audit and regulatory inspections.

MDSAP is Applicable to Which Class of Medical Devices:

This standard is applicable to Medical devices to Class II and above. Manufacturers of medical devices to Class I without any human or animal contact need not have this certification

Which are the participating countries that accept the certification to this standard:

USA: The Food and Drug Administration (FDA

Brazil: Brazil Agência Nacional de Vigilância Sanitária (ANVISA)

Canada: Health Canada (HC)

Australia: The Therapeutics Goods Administration (TGA)

Japan: Japan’s Ministry of Health, Labor and Welfare (MHLW)
Pharmaceuticals & the Medical Devices Agency (PMDA)

What is the future of ISO 13485 in view of this standard:

After March 31, 2016, MDSAP will be the primary means for a medical device manufacturer that markets its devices in the United States to participate in a Third-Party Audit program. Under MDSAP, the Food and Drug Administration (FDA) will accept MDSAP audit reports as a substitute for routine inspections.

‘The content of medical device regulatory audit reports must satisfy requirements for: third-party Quality Management System (QMS) audit reporting for Conformity Assessment (Australia); supporting an application for, or maintenance of a device registration request (Brazil); the manufacturer Good Manufacturing Practice (GMP) conformity evaluation (Brazil); a medical device license (Canada); QMS Inspection Guideline (Japan), or, a third-party audit for the United States”. (Source: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms)

What is the period of MDSAP Audit Cycle:  

The Medical Device Single Audit Program is based on a three (3) year audit cycle. The Initial Audit, also referred to as the “Initial Certification Audit” is a complete audit of a medical device manufacturer’s quality management system (QMS) consisting of a Stage 1 Audit (17021:2015 – Cl 9.3.1.2) and a Stage 2 Audit (17021:2015 – Cl 9.3.1.3). The initial Audit is followed by a partial Surveillance Audit (17021:2015 – Cl 9.6.2.2) in each of the following two (2) years and a complete Re-audit, also referred to as a “Recertification Audit” (17021:2015 – Cl 9.6.3.2) in the third (3rd) year.

(Source: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM390382.pdf)

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From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.

Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities

(Source; https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm)

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