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 DAkkS, the German Accreditation Body, is Germany’s national accreditation authority. Recently, manufacturers, associations, and certification bodies have been raising their voices against the DAkkS. It is being vilified as an example of how German bureaucracy nips any innovation in the bud. What is the truth of these accusations? Are they justified? This article presents…
Details“Remediation” is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets. This article will help you to complete such “remediation projects” in such a way that 1. Remediation: First…
DetailsFor 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. 1. Examples of phantoms in medical technology Anthropomorphic phantoms are replicas of bodies that behave like…
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. 1. What does a regulatory strategy determine? a) Background Manufacturers of medical devices must comply…
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. 1. General information on the 510(k) clearance by the FDA In contrast to the European jurisdiction…
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…
DetailsAs part of its “Vision 2030,” Saudi Arabia is planning to expand its healthcare infrastructure. Does this offer medical device manufacturers interesting growth opportunities? And with increased approval requirements, is the effort for approval worth it? Find out in this article how to approval in Saudi Arabia. 1. An interesting market for medical device manufacturers?…
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, 1. Definition: RIMS 2. Goals of RIMS Pharmaceutical and medical device manufacturers expect several…
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