Do you want to market your medical device worldwide (e.g. in Europe, the USA, China etc.) quickly, safely and at minimum cost? Then the Johner Institute is your perfect partner!
International approval planning
The Johner Institute’s regulatory affairs specialists will prepare the best approval strategy for you:
- Determining the classification
- If necessary, communicating with the regulatory authorities
- E.g. with the FDA or the Chinese National Medical Product Administration (NMPA, former CFDA)
- Organization of and participation in FDA pre-submission meetings
- Establishing whether a clinical evaluation using literature data is possible
- Selection of the admission, e.g. in the USA 510(k), Abbreviated 510(k), Special 510(k), PMA, De Novo requests, etc.
- Establishing which submission documents are required
Preparation for the international approval
As soon as the approval strategy has been established, the Johner Institute will help you prepare and review the necessary documentation, or will take complete responsibility for these steps:
- Selection of the test houses and supervision of the product tests required. The test houses must be accredited, e.g. by the Chinese NMPA
- (Support for the) conduct of clinical studies in the respective country
- Creating, amending, reviewing, improving, and compiling the technical documentation
- Translation of documentation, e.g. into Chinese