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.
What is the common denominator as it pertains to the requirements for the quality management systems?
Bauer: The MDSAP is based on the international standard ISO 13485 "Medical devices – Quality management systems – Requirements for regulatory purposes" and also takes into account all national quality system requirements of the participating countries that go beyond the requirements of the ISO 13485 standard. This includes particular country requirements such as registration, licensing, recalls, vigilance reports, et cetera.
Manufacturers need to be aware that during a MDSAP audit the Auditing Organizations cannot exclude the country specific requirements of those countries in which the manufacturer is actually selling.
How are costs and expenditures compared to the individual, country-specific audits?
Bauer: That always depends on the situation. When the FDA conducts an inspection for the U.S. market for example, the manufacturer does not need to pay anything. For an inspection by the Brazilian regulatory authority ANVISA the manufacturer has to pay a fee.
Each manufacturer individually has to decide if participation in the pilot is beneficial for his organization considering effort and downtime caused by separate audits or inspections of the four participating regulatory authorities.
What is being put to the test during the pilot stage?
Bauer: The four participating regulatory authorities, participating manufacturers as well as the Auditing Organizations need to generally gain experience on the overall process. I am going to give you a few examples. This includes the overall documentation that accompanies an audit. It needs to be determined how well this works. Another example is the calculation of the audit duration, which is nearly irrespective of the number of employees when it comes to the MDSAP. In contrast, the number of employees is the main parameter for audit time calculation in an ISO13485 audit. Time will tell whether this calculation model is adequate or whether it needs to be adjusted.
The MDSAP also has a detailed system to classify nonconformities. The system follows a document (SG3/N19) developed by the Global Harmonization Task Force (GHTF), which classifies nonconformities into five grades. The experience gained during the pilot phase will determine if this system is adequate.
What does the future hold after the pilot stage is over?
Bauer: The regulators are confident that this program will be fully implemented, however, experiences have to be gained from the audits performed within the pilot phase. The regulatory agencies will witness the Auditing Organizations during their first audits. The initial audited manufacturers will get the chance to provide their feedback on the program. The regulators need to collect all information and then decide about adjustments to the program.