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.
A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
DetailsThe authorization of medical devices in Japan is a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world. This article will tell you about the requirements you have to meet and the best way to overcome the hurdles. A)…
DetailsThe CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health. This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in China. You will…
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…
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.