Support in getting your medical devices approved
The team of experts at the Johner Institute support you in all steps of approval - and beyond.
Step 1: Develop approval strategy
The Regulatory Affairs specialists at the Johner Institute develop the best approval strategy for you:
- Determine the appropriate classification.
- If necessary, communication and coordination with authorities e.g. with the FDA or the Chinese "National Medical Product Administration" (NMPA ex. CFDA). For example, our experts can organize FDA pre-submission meetings and take part on your behalf or alongside you.
- Determine whether a clinical evaluation based on literature data is possible, saving the need for a clinical study.
- Selection of the approval process e.g. in the USA 510(k), Abbreviated 510(k), Special 510(k), PMA, applying for a de novo request, etc.
- Support in the selection of possible comparable products ("predicate devices" in the USA).
- Determine the necessary submission documents.
Step 2: Prepare for international approval
As soon as the admission strategy is in place, the Johner Institute will help you prepare for approval:
- Compilation of submission documents
We create, check and improve the technical documentation for you (e.g. a risk management file). In doing so, we reuse existing documents and observe the applicable standards and guidance documents.
This helps us save you producing redundant documents and thus effort and costs. We structure your documentation in such a way that it can be used for as many countries as possible worldwide without requiring major adjustments.
- The Johner Institute will help you select test centers and will undertake or accompany the required product tests. Test centers often have to be accredited, e.g. by the Chinese NMPA.
- We support you in conducting clinical studies in the respective country.
- The experts at the Johner Institute adapt your QM system to the respective country requirements.
- We take care of translations of documentation into e.g. Chinese.
Step 3: Approve and register medical devices
The next step is the actual approval, in which the Regulatory Affairs experts at the Johner Institute will also closely accompany you:
- Submission of approval documents.
- Registration of products and manufacturers.
- Selection of a local authorized representative, e.g. China Legal Agent or US Agent. The Johner Institute can also provide such agents itself, depending on the country.
- Communication with the authorities, especially in the case of queries.
Step 4: Monitor products, regulations and certificates
We will accompany you even after successful approval. We manage your certificates and inform you of pending certificate expiration in good time. Our Regulatory Radar keeps you up to date on relevant regulatory changes in your target countries and we support you in fulfilling the regulatory requirements and with new submissions and certificate renewals. Our Post-Market Radar takes care of a large part of the legally required information gathering within the scope of post-market surveillance.
Continuous optimization of regulatory affairs processes
Do you already have internal regulatory affairs processes or processes in cooperation with national companies? We help you
- obtain an overview of the quality of your processes and documents and
- identify and simplify inefficient RA processes;
- thus avoiding unnecessary overheads (personnel, documents, processes) and
- in this way, obtain approval for your products faster and with fewer interactions.
Get in touch with us now to legally market your medical devices worldwide without unnecessary delays and costs.