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:

Information on the requirements of the markets

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:

Further information

This information is also relevant for international approval:

  • 5 steps to new markets
  • Dealing with free sales certificates
  • Medical Device Single Audit Program (MDSAP)
  • CB reports
  • Comparison of approval in the EU and the USA


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.

Why you should consider clinical studies in Australia 

Conducting 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…


Understanding and avoiding deviations and nonconformities

Deviations, 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…


7 tips for the successful digital transformation of medical device manufacturers

Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…


DAkkS: What’s behind the outrage about ISO 13485?

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…


Remediation: When things hit the fan

“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…


Phantoms in medical technology

Phantoms 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…