DNV Accredited by MDSAP for Streamlined Medical Device Audits

DNV Accredited by MDSAP for Streamlined Medical Device Audits

(IN BRIEF) DNV has achieved recognition as an auditing organization under the Medical Device Single Audit Program (MDSAP), enabling it to conduct consolidated regulatory audits for medical device manufacturers. This designation streamlines global market access by fulfilling the compliance requirements of multiple regulatory authorities through a single audit process. The MDSAP includes major bodies like the FDA, TGA, HC, MHLW/PMDA, and ANVISA, along with affiliate members, aiming to reduce administrative burdens and enhance regulatory efficiency.

(PRESS RELEASE) BÆRUM, 27-Jun-2024 — /EuropaWire/ — DNV has been officially recognized as an auditing organization by the Medical Device Single Audit Program (MDSAP). This designation allows DNV to conduct single regulatory audits of medical device manufacturers’ quality management systems, simplifying compliance processes and providing global market access.

This recognition enables medical device manufacturers to meet the regulatory requirements of all participating authorities through a streamlined audit process.

The MDSAP includes five primary regulatory authorities and several affiliate members:

Primary Regulatory Authorities:

1. United States Food and Drug Administration (FDA)
2. Therapeutic Goods Administration of Australia (TGA)
3. Health Canada (HC)
4. Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
5. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)

MDSAP Affiliate Members:

1. Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
2. Ministry of Health of Israel
3. Kenya’s Pharmacy and Poisons Board
4. Republic of Korea’s Ministry of Food and Drug Safety
5. Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
6. Taiwan Food and Drug Administration (TFDA)

The MDSAP aims to reduce the administrative, financial, and approval burdens on manufacturers by combining audits from various regulatory bodies into a single audit. This approach minimizes the need for multiple audits and inspections by different authorities.

The audit covers a comprehensive range of aspects related to medical device manufacturing, including management responsibilities, quality audits, product realization, and measurement, analysis, and improvement.

Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV, stated, “DNV’s involvement in MDSAP underscores our commitment to supporting the medical device industry’s regulatory compliance and quality assurance needs. By leveraging our extensive expertise and global reach, we are dedicated to helping manufacturers achieve sustainable success and maintain trust in their products.”

Media Contacts:

Mona Ghobadi
Global Head of External Relations
Phone: +49040361497484
Mona.Ghobadi@dnv.com

Zaher Kharboutly
MDSAP Program Manager
Zaher.Kharboutly@dnv.com

SOURCE: DNV