Opening up the international market for manufacturers together

Global competition for medical technology companies continues to grow. To remain successful, companies have to position themselves in key global markets. Country-specific safety standards continue to pose major challenges for medical device manufacturers. Because of this, CSA Group and BSI Group have formed an alliance to help companies introduce their products quickly and successfully.

Photo: Smiling man with a white shirt - Hans-Werner Zeller; Copyright: CSA Group

Hans-Werner Zeller, Senior Business Development Manager Europe, Health, Safety & Technology, CSA Group; ©CSA Group

Hans-Werner Zeller, Senior Business Development Manager Europe of CSA Group, and Dr. Gert Bos, Head of Regulatory and Clinical Affairs of BSI Group, explain how manufacturers can successfully position their products on the global market.

Mr. Zeller, how do you want to open the North American market for European companies with your partnership?

Hans-Werner Zeller: CSA Group is a world leading testing and certification institute from Canada with almost 100 years of experience and with testing laboratories all over the world. We traditionally have an extremely strong expertise in North America and are a National Recognized Test Laboratory (NRTL) in the US, which makes us an accredited laboratory for North America. BSI is a Notified Body in Europe and a registrar for the North American market. Together we can offer customers integrated services in the context of complex, country-specific product testing and certification procedures.

What standards, laws, regulations within the scope of testing and certification are especially relevant for the North American market?

Zeller: Firstly, this depends on where exactly the product shall be authorized. For the Canadian market there is the Medical Device Regulation (MDR), which includes various risk classes. From a certain class on medical device manufacturers have to demonstrate a certified quality management. The certification is carried out by an authorized institution under the rules of the MDR. Here it is an advantage if the manufacturer already has a Quality Management System which is certified according to the applicable standard for medical devices.

The FDA regulations in the US can rather be regarded as guidelines, in contrast to the European Medical Device Directive (MDD) with mandatory legislative acts. In the United States it is not required for manufacturers to have a quality management system certified according to certain ISO standards. The FDA guidelines always point to 'Good Manufacturing Practice', a rather vague term that can be interpreted more or less strict by the FDA on the occasion of their visits to a medical technology device manufacturer. It is also an advantage, if a manufacturer has a certified quality management system in place. Looking at the requirements, Mexico can be compared to the FDA. If a manufacturer has US approval, there are hardly any difficulties in entering the Mexican market.

In our test labs, we run tests that are accepted by Health Canada and the FDA in the context of product approvals. Our CSA certification mark is recognized under the NRTL by the 'Authorities Having Jurisdiction' and the products can be operated in North America without further obstacles.Die CSA Group führt in ihren Prüflaboren Prüfungen durch, die von Health Canada und der FDA im Rahmen von Produktzulassungen akzeptiert werden. Unser CSA-Prüfzeichen wird von den 'Authorities Having Jurisdiction' (AHJ) im Rahmen des NRTL anerkannt und die Produkte können so ohne weitere Hürden in Nordamerika betrieben werden.
Photo: Smiling man with suit, red tie and glasses - Dr. Gert Bos; Copyright: BSI Group

Dr. Gert Bos, Head of Regulatory and Clinical Affairs at BSI Group; ©BSI Group

Dr. Bos, what further requirements must be met by companies in order to enter the North American market?

Dr. Gert Bos: For admission into the US market, manufacturers must follow the QSR requirements for the quality system and must have the approvals 510k, IDE or PMA for their products. 510k is a product approval based on substantial equivalence. IDE is an inquiry carried out by the FDA to approve products in order to conduct a clinical trial phase. PMA is an FDA approval which is performed before new and high-risk products are placed on the market. The QSR requirements are evaluated irregularly by the FDA. Some BSI auditors also work as FDA inspectors.

Are your certificates and audits accepted by the FDA?

Bos: BSI ISO 13485 audit reports and certificates are not accepted by the FDA; MDSAP audit reports are accepted by the FDA. BSI is a qualified Audit Organization (AO). This MDSAP audits cover several regulatory areas, including US QSR requirements. The audits are fully recognized by the FDA.

Mr. Zeller, are there other international markets that you seek to enter together in the future?

Zeller: Through the cooperation of CSA and BSI we enable manufacturers from around the world not only to access the North American market but also the key markets of Asia and Europe. And this is very well received by our mutual customers.