medical endoscopy

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WORLDWIDE APPROVAL

Focus topic: Canada and the USA

So that our products fulfill all internationally required regulatory demands, we rely on our own team of experts and on a certified quality management system.

The team of experts consists of qualified, experienced people responsible for all product and country-specific approvals. They work hard to see that a direct submission is made to the notified body and to the correct authority, such as the FDA (USA), Health Canada, ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Columbia), SFDA (Saudi Arabia), CFDA (China) and is carried out as quickly as possible.

What is the advantage for you? By taking over our approval and the article number of the available standard products, you can sell the products quite quickly under your brand. As manufacturer, we assume product responsibility and post market activities. If you want to act as manufacturer of the product yourself, we will support you with the necessary testing, documentation and regulatory questions.

Canada – Approval for Health Canada

We have the QM Certificate for Canada and a major part of our standard products are approved by Health Canada. If you take over our approval and article number, you can start sales immediately.

USA – FDA Approval

Our complete standard product program is approved in the USA. This means that here as well, under the conditions noted above, you can start sales at once. For all our standard products we have the 510 (k) approvals or the necessary Device Listing.

The Food and Drug Administration (FDA), responsible for food and medications and also for approval of most of the medical devices sold in the USA, divides medical products into three classes. These product classes indicate whether an approval from the FDA is necessary.

As a rule, for Class I products, those which represent a low risk for patients and operators and are categorized as low risk, no FDA approval is necessary. For these products, a Device Listing is sufficient. For Class II products, those which represent an average risk for patients and operators, a release by the FDA is necessary in most cases. All medical products in Class III, which represent the highest risk for patients and operators or for which no comparable products exist, must be approved by the FDA previous to introduction onto the market. In this case, a Premarket Approval (PMA) by the FDA is usually necessary.

To be sold in the USA, some Class I products, as well as most of the medical products of Class II are required to have a 510(k) release by the FDA. The 510(k) approval process is time-consuming and can, depending on the product, be very complicated. Clinical and technical comparability of the own product to a competitive product must be shown (the so-called predicate device) and a great number of documents must be submitted, whose contents go far beyond those of user instructions. The documents pass through different departments of the FDA and are examined thoroughly by experts. This high standard is generally recognized and the requirements set by the FDA are accepted in many countries. The FDA is considered worldwide to be a pacesetter in terms of quality management and approval.

One hotly discussed topic at the moment is the Unique Device Identification (UDI), which increases patient safety and simplifies product recalls. The UDI system stems from a proposal of the FDA, its introduction is also planned for Europe.

 

Technical specifications are subject to change. The information is not legally binding. The contents are only for information about our products. Reprint, in whole or in part, is not permitted. Medical devices are only allowed to be marketed and used in countries where they have been approved for sales by regulatory authorities. For information on the available market access please contact us.