Initial situation
We were contacted by a European manufacturer of a neuromodulator for the treatment of chronic pain. The product is an active implant of risk class 3. At the time of the request, the customer did not have a single analogue registered in the Russian Federation. The regulator required an expanded clinical program and toxicology according to the new rules; the documentation was prepared according to EU standards and did not meet the requirements of the EAEU.
What we did
- Audit of the initial dossier: 47 non-compliances with regulatory documentation were identified
- Adaptation of technical specifications and instructions for use to the requirements of GOST R 50444
- Development of a clinical trial program with the participation of 3 federal medical centers
- Support of toxicological tests based on an accredited laboratory
- Submission of registration dossier through EPGU, support of examination in Roszdravnadzor
- Passing a production inspection in Germany with the participation of agency experts
Issued Registration Certificate
The registration certificate was received without a single request for revision. The manufacturer entered the register of the VMP program and entered into contracts with 4 federal medical centers in the first 6 months after registration.