Regulatory affairs: support for the international approval of medical devices
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
Support during the international approval process
The next step is the actual approval, during which you will likewise be closely accompanied by the Johner Institute's regulatory affairs experts:
- Submission of approval documents
- Registration of medical devices and manufacturers
- Selection of a local representative, e.g. China Legal Agent or US Agent. The Johner Institute can also appoint these people itself
- Communication with the authorities, particularly in the event of queries
Contact us right now to legally market your medical devices worldwide without unnecessary delays and costs.