A single audit to access to the medical device market of the 5 member countries.
The Medical Device Single Audit Program (MDSAP) is a certification scheme that allows a medical device manufacturer to verify compliance with the regulatory requirements of 5 countries through a single inspection by a Notified Body.
Which Regulatory Authorities are involved in MDSAP?
- TGA, Australia
- ANVISA, Brasile
- Health Canada, Canada
- U.S. Food and Drug Administration, FDA
- MHLW and PMDA, Japan
What are the benefits for a medical devices manufacturer?
- Single combined audit ISO 13485, MDSAP and CE marking with consequent reduction of time and costs.
- A single system to meet the requirements of the Regulatory Authorities of the 5 countries in which the device is marketed.
- FDA, ANVISA and MHLW accept MDSAP audit reports instead of their own audits at the manufacturer.
- Australian TGA accepts the MDSAP certificate as ISO 13485 compliance and takes the same certificate into consideration to avoid a periodic audit at the manufacturer.
- Health Canada uses the MDSAP certificate to maintain the validity of the Canadian license.
What is the MDSAP Certification process?
An MDSAP audit is conducted by Notified Bodies recognized for the certification scheme.
Three-year audit cycle, structured as follows:
- Certification Audit- MDSAP
- Surveillance Audit - Year 1
- Surveillance Audit - Year 2
- Re-certification Audit - Year 3
The Medical Device Single Audit Program offers an opportunity for medical device manufacturers to gain access to multiple geographies through an efficient single audit process.