MDSAP, Medical Device Single Audit Program, is a special program designed for manufacturers to complete their
- Australia TGA (Therapeutic Goods Administration)
- Brazil ANVISA (Agencia Nacional de Vigilancia Sanitaria)
- Canadian Ministry of Health (Health Canada)
- USA FDA (Food and Drug Administration)
- Japan MHLW (Ministry of Health, Labour, Welfare) audit processes -through a single audit.
As of January 1, 2019, Canada has made it mandatory for Medical Device companies to only be certified in compliance with the Medical Device Single Audit Program (MDSAP). Other relevant Regulatory Authorities are expected to do the same over time. Therefore, audit organizations have also started to prepare and implement MDSAP.
Purpose of MDSAP
The most significant benefit of MDSAP is that it will provide serious convenience for manufacturers who want to reduce their risk and focus on profitable markets by performing sales in different countries.
Some other purposes of MDSAP can be listed as follows:
- Ensure appropriate regulatory oversight of manufacturers' quality management systems while minimizing the burden of regulations on the medical device industry;
- Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
- To achieve greater compliance with regulatory approaches and technical requirements based on international standards and best practices in the long term;
- To standardize the consistency, predictability and transparency of regulations.
The purpose of an MDSAP-recognised Auditing Organization is to verify that the medical device manufacturer is taking appropriate actions, ensuring that the relevant requirements of participating regulatory authorities are met through a single audit. The Auditing Organization reviews all product-related activities and handles such activities in 5 separate but interconnected processes.
- Management
- Measurement, Analysis, and Improvement
- Design and Development
- Production and Service Controls
- Purchasing
You can access the MDSAP-related websites of relevant countries from the links below.
The United States
Brazil
Canada
Australia
Japan
