Dental implants of foreign production

Application for registration is prepared..

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 made the contracts with them

We prepared the documents for obtaining an import permission and submitted them to Roszdravnadzor. Received an import permission

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 manufacturer review) and in Russian.
The Russian version was agreed with the customer (authorized representative in Russia).

Received samples, sent to laboratories for technical and toxicological tests

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 protocols draft for technical and toxicological tests from laboratories, checked, confirmed with the customer and manufacturer. Test protocols were issued by laboratories.

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

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

Received the draft of clinical trial protocols. Checked, confirmed with the customer, manufacturer, sent to the laboratory for release.

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

Received a request from an expert organization to provide additional materials and information. We requested the necessary documents from the manufacturer, sent them for legalization. Prepared and sent documents for signing by the customer.

Arranged for the release of an addendum to the clinical trial protocols. We received documents legalized by the manufacturer, organized their translation and notarization. Received documents from the customer. Submitted an answer to the request

Received a registration certificate