Case Study 1: Registration of an Imported Diagnostic Test (In Vitro, Germany)
Goal:
Introduce a COVID-19 PCR diagnostic kit to the Russian market.
Steps:
- Translation and adaptation of the Technical File to meet Russian standards;
- Kit preparation: registration dossier + samples;
- Conducting toxicological and clinical trials in an accredited laboratory;
- Preparing protocol drafts and assessing compliance;
- Submission to Roszdravnadzor.
Challenges:
- Labeling inconsistency (no Russian text);
- Additional requirement for clinical trials in the Russian Federation;
- Need for urgent registration (during the pandemic).
Solutions:
- Urgent translation and adaptation of packaging;
- Submission under an accelerated procedure (for COVID-19 products);
- Simplified effectiveness assessment model based on the Ministry of Health's interim methodology.
Result:
Registration received in 70 days (instead of the usual 8-12 months). The product entered the Russian market and became part of government procurement.
Case 2: Registration of a Dental Unit (Italy)
Product Classification:
Risk Class 2a (medium risk), electrically powered medical equipment.
Steps:
- Confirmation of compliance with standards (electrical safety, biocompatibility);
- Conducting technical, toxicological, and clinical trials;
- Preparing technical documentation and instructions in Russian;
- Registration with Roszdravnadzor.
Challenges:
- Registration denied due to "incomplete list of tests" (GOST electrical safety requirements not taken into account);
- Requirement for localization of service and documentation.
Solutions:
- Conducting missing tests in the Russian Federation;
- Renewing the passport in Russian;
- Registering a representative office in the Russian Federation – as the applicant.
Result:
Marketing approval was received after nine months. The product began shipping to dental clinics.
