Medical devices are expensive. Not just for physicians and patients, but initially for manufacturers. They invest time and money in research and development, building prototypes and performing studies. Before the devices can be sold, the company undergoes quality management audits that are currently different for each country. Now an international pilot program aims to simplify this process.
At COMPAMED.de, Georg Bauer, Department Manager Foreign Affairs at TÜV Süd Product Service GmbH, talks about the Medical Device Single Audit Program MDSAP. The audits in this program combine the quality audits for four national markets.
Mr. Bauer, what is the MDSAP?
Georg Bauer: The MDSAP was initiated by the International Medical Device Regulators Forum (IMDRF). It is currently still in its pilot stage, which will last until the end of 2016. Under MDSAP, all requirements for the quality management systems of the manufacturers of medical devices and other particular country specific requirements according to the regulations applicable in Canada, Australia, Brazil and the USA can be assessed in a single audit.
If I wanted to sell a new product in these countries as a medical device manufacturer, I would benefit in participating in this program.
Bauer: That is a correct statement, however we should add that this also applies to those manufacturers who are already present in the respective market and not just those that launch a new product into this market, or actually want to enter this market for the first time. Any manufacturer in the world, who is represented in one or several of these markets with either one or several products, can participate in this pilot program.
TÜV SÜD America is also participating as an auditing organization…
Bauer: That is correct. It is important to use the proper terms here. TÜV SÜD America is authorized by the MDSAP Regulatory Authority Council (RAC) to conduct audits as part of the pilot program.
…what criteria do organizations need to meet that wish to conduct audits within the scope of this program?
Bauer: Any organization that is on the list of Health Canada’s CMDCAS recognized registrars can apply to participate in the pilot program. Health Canada is Canada’s regulatory medical device authority.