Kiwa has been accepted as MDSAP Auditing Organization applicant
This is an important step in Kiwa’s continued development of services for the medical device sector. Applicant status means Kiwa has entered the formal process toward recognition as an MDSAP Auditing Organization.
What is MDSAP?
The Medical Device Single Audit Program is an international regulatory audit programme for medical device manufacturers.
MDSAP allows a recognised Auditing Organization to conduct a single audit of a manufacturer’s quality management system that can satisfy the relevant requirements of multiple participating regulatory authorities.
MDSAP was developed to support greater international regulatory alignment, improve audit consistency, and reduce duplication of effort for manufacturers operating across multiple markets. Participating jurisdictions include major medical device markets such as Australia, Brazil, Canada, Japan and the United States.
For manufacturers, MDSAP can help streamline regulatory oversight by replacing multiple separate audits with one structured audit programme. For regulators, it provides a consistent approach to assessing compliance with quality management and country-specific regulatory requirements.
Kiwa’s acceptance as an applicant marks a positive milestone in strengthening its role in global medical device assurance and supporting manufacturers with efficient, internationally recognised audit pathways.
AO Contact details
Information is provided here on AOs available to conduct audits of medical device manufacturers under the MDSAP, including the status of their authorization to conduct MDSAP audits, and their recognition.
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