Abbreviated 510(k) – When the abbreviation is allowed
Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
DetailsThe 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:
- USA / FDA
- Brazil and INMETRO
- China
- Great Britain, Brexit
- Japan
- Russia and the Eurasian Federation
- Saudi Arabia
- South Korea
- Switzerland
- Turkey
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
Support
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.