1. The ClientA
Russian-based company seeking registration of their product in the EAEU market.
Initial Situation: The client had already submitted an application independently but received a
rejection. The reason: they had applied in the
medicine category, which was incorrect for their product.
2. The Challenge- The client's application was rejected due to incorrect product classification (medicine instead of medical devices).
- The client had already invested time, money, and effort into a previous analysis conducted in Kazakhstan.
- They needed to restart the process without losing the value of their prior work.
- A new full analysis would have been costly and time-consuming.
3. Our SolutionSoloreg provided strategic guidance and practical support to turn the situation around:
- Correct Classification: We reviewed the product and identified that it falls under medical devices, not medicines — which was the root cause of the rejection.
- Reuse of Prior Work: We advised the client to reuse the analysis already conducted in Kazakhstan, which was fully valid for the correct category.
- Submission from Kazakhstan: We prepared and submitted the case from Kazakhstan using the same analysis, which was accepted by the Ministry of Health.
- Full Support: We guided the client through every step to ensure maximum utilization of their previous work.
4. The ResultIndicator | Achievement |
Correct Classification | Product successfully reclassified as a medical device instead of a medicine. |
Reused Analysis | Prior analysis from Kazakhstan was fully utilized and accepted by the MoH. |
Time Saved | Client avoided a full re-analysis, saving significant time. |
Finance Saved | Client avoided the cost of new analysis and re-submission from scratch. |
Registration Status | Application accepted by the Ministry of Health. |
