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.
“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
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.
DetailsManufacturers of (most) class III medical devices have to undergo the Premarket Approval (PMA) procedure. That is one of the FDA’s most complex submission pathways, with a typical processing time of more than one year. The FDA usually approves only a few dozen PMA applications per year. This article presents the FDA’s requirements and tips…
DetailsThe DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works.
DetailsThe 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.
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…
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