Medical Device
Single Audit Program (MDSAP)
The Medical Device Single Audit Programme (MDSAP) is a specific certification based on the requirements of ISO 13485 and extended by country-specific requirements for Australia, Brazil, Japan, Canada and the USA. The MDSAP certificate is mandatory in Canada for products from Class 2 upwards. In the other countries, the approval process can be shortened or audits by the respective national authorities can be reduced.
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mdc - our offer for MDSAP
As part of a cooperation with an auditing organisation recognised under the MDSAP, we offer our customers audits under the MDSAP. You therefore receive certifications and audits for CE marking, ISO 13485 and MDSAP from a single source.
What is meant by MDSAP
The Medical Device Single Audit Programme (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF), an association of international authorities and legislators. MDSAP represents a common regulatory standard for quality management audits of medical device manufacturers that is recognised by several countries. The audits are carried out by auditing organisations that are authorised to do so. The aim of the authorities involved is to maintain a uniform and consistent approach by the auditing bodies through the programme. Instead of many audits and inspections by authorities in different countries, there should only be one audit by one auditing organisation.
The following countries and authorities are currently participating in the MDSAP:
Country | Authority |
---|---|
Australia | Therapeutic Goods Administration (TGA) |
Brazil | Agência Nacional de Vigilância Sanitária (ANVISA) |
Japan | Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) |
Canada | Health Canada (HC) |
USA | Food and Drug Administration (FDA) |
We offer those interested in this additional service the opportunity for an initial exchange of information.
CONTACT OUR TEAM FOR SERVICES FOR THIRD COUNTRIES
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