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 United Arab Emirates (UAE) with its hubs Dubai and Abu Dhabi is one of the most developed economies in the Middle East. The Emirates is among the wealthiest countries in the world. The healthcare system is considered highly developed, which is why the United Arab Emirates (UAE) is a popular health tourism destination in…
DetailsThe NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are. 1. Whom the NMPA Usability Guidance concerns a) Included and…
DetailsThe Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
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…
DetailsBrexit was completed in January 2021. What was a cause for celebration for some means an additional burden for many – including medical device manufacturers. For manufacturers, it is important to understand which regulatory requirements they will have to fulfill and which transition periods they will benefit from if they want to continue selling their…
DetailsWith the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part. 1. What is…
DetailsIt is not easy to get medical devices approved in Brazil. This is due to the number of regulations, their complexity, and the fact that Brazil has published most of the regulations in Portuguese only. This article provides an overview and highlights similarities with the European and US systems. This will make it easier for you…
DetailsOrphan medical devices are medical devices (and IVDs) for small patient groups. The development of these niche products is often not profitable for manufacturers. As a result, particularly vulnerable groups, such as children, do not always receive adequate medical care. This article shows possible solutions and classifies the guideline MDCG 2024-10. 1. Orphan medical device:…
DetailsConducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages. 1. Advantages and disadvantages of clinical studies in Australia 1.1 Advantages of clinical studies…
DetailsDeviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies, 1. Nonconformities: The basics 1.1 Definitions 1.1.1 Nonconformity ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” It equates this term with “error.” ISO 13485 contradicts this. This standard…
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