The international approval of medical devices is a challenge for most manufacturers. This is because the regulatory requirements differ in the various markets.
On this page, you will find links to further information that is helpful for international approval:
The regulatory requirements for approving and monitoring medical devices on the market are similar. But they are not congruent. The following articles provide a quick overview:
This information is also relevant for international approval:
The Johner Institute provides support with international approval. It also acts as an authorized representative in other markets, such as the UK and Switzerland.
Contact us to clarify the next steps to get your devices to all desired markets quickly and safely.
The 510(k), also known as “Premarket Notification”, is one of the most common procedures for the authorization of medical devices in the USA. The concept is based on demonstrating equivalence with a predicate device (equivalent device). But the same mistakes, which can result in the entire 510(k) authorization failing, are made time and again. It…
DetailsWith its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations. In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and…
DetailsAbbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you, 1. Abbreviated 510(k) and other approval procedures If manufacturers want to market their medical devices in the U.S., they must go through one of the approval procedures. Among the most commonly used are the Premarket Notifications PMN. These…
DetailsWith the Pre-Submission Program (“Pre-Sub” for short), the FDA offers a formal procedure for manufacturers to clarify their regulatory strategy and specific questions before actual approval or market clearance. A pre-sub request is suitable in the preparation of 510(k)s, De Novo Requests, or PMAs, among other things. This can avoid unnecessary costs and effort on…
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