MDSAP
The Medical Device Single Audit Program (MDSAP) is designed to allow for a more streamlined Quality Management System by allowing medical device companies to prove compliance through a single audit for participating markets.
At this moment in time, MDSAP is accepted in the following 5 markets: Australia, Brazil, Canada, Japan and the USA. If you are considering market access for Canada then it is mandatory for you to seek MDSAP certification. For Australia, Brazil, Japan and the USA it is not mandatory but makes the process easier should you wish to market your medical devices in more than one of these markets.
Although MDSAP mostly aligns with ISO 13485, audits are conducted by MDSAP-recognized Auditing Organisations. Similarly to ISO 13485, audits are conducted on a three-year cycle which includes an initial certification audit followed by annual surveillance audits with a recertification audit after three years.
The benefits of such a system are an overall reduced cost of having to pay for multiple audits and also a reduced amount of time and resources for dealing with findings from several different audits. Although it is important to note that MDSAP in itself is not a replacement for ISO 13485 certification.
Best Practices
Align with internationally recognised standards.
MDSAP certification alone does not mean that you won’t be audited by the authorities within these markets, for example, within the USA although the FDA accepts MDSAP audit reports as an alternative for FDA routine inspections, any compliance related issues may still be investigated by the FDA themselves. A similar approach can also be taken within the other four markets.
Get in touch
Getting healthtech to market doesn't have to be difficult.