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.
For many manufacturers of medical devices, an FDA inspection is associated with great stress. Many companies are aware of the possible consequences, such as a public warning letter and even criminal prosecution. But they often don’t know how to avoid these consequences without shutting down the entire company for days. This article shows how This…
DetailsPhantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet.
DetailsDefining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers. Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers.
DetailsThe term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, however, define what “substantial equivalence” is. Sounds complicated? Demonstrating equivalence is by no means only relevant in the FDA context. That’s why this article provides clarity – especially but not…
Details510(k) clearance is the primary procedure for obtaining marketing clearance in the United States. It is also referred to as Premarket Notification (PMN). This article provides a quick overview of the procedure and the documents that must be submitted.
DetailsA German medical technology industry analysis from 2020 estimated the market for medical devices in South Korea at USD 6.7 billion. Due to an annual growth rate of imports of (estimated) 10% and the increasing aging of the population with a simultaneous increase in basic medical care, the South Korean market is expected to grow…
DetailsMedical device manufacturers have high expectations of Regulatory Information Management Systems (RIMS). The costs and efforts involved are immense and usually much higher than expected. The benefits, on the other hand, are not clear. This article will give you some hints,
DetailsMany companies consider Regulatory Intelligence so important that they create their own roles and departments for it. This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support.
DetailsMedical device certification, MDR certification, CE certification. These are terms that are used frequently. But is there even such a thing as medical device certification? This article answers the question.
DetailsFrom 2017-2022 the FDA offered a “Precertification (Pre-Cert) Pilot Program” to specific companies for standalone software to simplify and accelerate the approval process for digital health devices. This article summarizes the most important aspects and provides a quick overview.
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