For those considering entry into the medical device market (Australia, Brazil, Canada, Japan, United States).

For those considering entry into the medical device markets (Australia, Brazil, Canada, Japan, and the United States), we introduce the MDSAP review.
MDSAP is a method that allows medical device manufacturers to undergo a single audit for compliance with standards and regulatory requirements in up to five different medical device markets (Australia, Brazil, Canada, Japan, and the United States). The Medical Device Single Audit Program (MDSAP) is an audit of the quality management system (QMS) of medical device manufacturers, enabling them to meet regulatory requirements across multiple jurisdictions with a single audit.
【Benefits for Customers】
- Access to up to five markets with a single procedure
- Includes requirements from Australia, Brazil, Canada, Japan, and the United States
- Saves time and resources by consolidating findings from multiple audits
- Planned audit content
- Cost savings compared to individual audits
- Recognized track record in medical device registration, leading to reduced local inspections by participating authorities
【Flow to the MDSAP Certification Process】
Relevant materials are attached.

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