FULL CYCLE OF MEDICAL DEVICE REGISTRATION

Together with the customer, we determined the list of registered sets and made an application to registration.

We asked the manufacturer for all the necessary documents and sent them for translation. We prepared a power of attorney from the manufacturer to an authorized representative of the manufacturer, sent it to the manufacturer for legalization. Received a legalized power of attorney, prepared its translation and notarization of the translation.

We sent requests to testing laboratories to calculate the cost and timing of toxicological, technical and clinical tests, as well as the number of samples. We chose laboratories that were optimal in terms of time and cost and signed the contracts with them.

We prepared the documents for obtaining an import permission and submitted them to Roszdravnadzor. An import permission was received.

At the same time, in parallel with clauses 2 and.3, we received translations of documents, checked them and corrected them where necessary. We prepared technical documentation (including test reports from manufacturer) and operating instructions in English (for agreement with the manufacturer) and in Russian.
The Russian version was agreed with the customer.

Received samples, sent to laboratories for technical and toxicological tests

We Prepared the rest of the registration dossier documents (explanatory letters, statements, photographs, etc.). Where necessary, documents were prepared in English. Some of the documents were sent to the manufacturer for legalization, and some were sent to the customer for signing.

We Received draft protocols of technical and toxicological tests, checked, confirmed with the customer, test reports were issued by laboratories.

We Received legalized documents, organized their translation and notarization. Received documents signed by the customer. We formed a registration dossier and submitted it to Roszdravnadzor. The incoming tracking dossier number is issued in the applicant's personal account.

The request from an expert organization is issued to provide additional materials and information. We requested the necessary information from the manufacturer, prepared an addendum to the technical documentation, and sent it for legalization. Prepared and sent documents for signing by the customer.

We arranged for the release of an addendum to the test reports. We received documents legalized by the manufacturer, organized their translation and notarization. Received documents from the customer. Submitted an answer to the request to Roszdravnadzor

Received permission to conduct clinical trials. We organized the clinical trials, sent samples of products and the necessary documents to the clinic. We submitted to Roszdravnadzor the notification about the start of clinical trials

We have prepared the documents required for submission. Some of the documents were sent to the manufacturer for legalization, and some were sent to the customer for signing.

We received the draft clinical trial protocols. Checked, confirmed with the customer, sent to the clinic for release.

We received documents legalized by the manufacturer, organized their translation and notarization. Received documents from the customer. Submitted documents for the second stage of registration

Received a registration certificate