DNV has been recognized as auditing organization by the Medical Device Single Audit Program (MDSAP). As a MDSAP-recognized auditing organization, DNV is now recognized to conduct a single regulatory audit of a medical device manufacturer’s quality management system.
This audit provides medical device manufacturers with global market access through a streamlined compliance process by meeting the relevant requirements of all regulatory authorities participating in the programme.
The programme includes five primary regulatory authorities and participating MDSAP Affiliate members:
I. Five 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/PMD]
5. Brazil’s Agência Nacional de Vigilância Sanitária [ANVISA]
II. 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 (NEW)
4. Republic of Korea's Ministry of Food and Drug Safety
5. Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
6. TFDA - Taiwan Food and Drug Administration
By combining audits from these different regulatory bodies into a single audit, MDSAP aims to reduce the administrative, financial and approval burden on manufacturers and streamline the regulatory compliance process. This minimises the need for multiple audits and inspections by different regulatory authorities.
A wide range of aspects related to the manufacturing of medical devices are covered as part of the audit, including management responsibilities, quality audits, product realization, and measurement, analysis, and improvement.
„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 product,” said Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV.