November 20, 2020

Medica explains to startups how to register medical appliances

Medica company  (part of the TechnoSpark Group of Companies within the investment network of the Fund for Infrastructure and Educational Programs of RUSNANO Group) specialises in registration, certification and localisation of medical appliances. On 29 October, they held a webinar for startups on the registration procedure and changes in the legislation.

Medica provides its services in medical appliances registration and is familiar with what difficulties a startup may face at the stage of getting their developments to the market. The portfolio of Medica comprises several cases of successful entering the Russian market by foreign producers of medical appliances, such as Visionix Rus multipurpose ophthalmologist devices.

In the frame of Registration of Medical Appliances Webinar held for the Russian biomedical startup, Ekaterina Khodunova, head of Medica, presented the general algorithm to obtain a registration certificate. In Russia, you need 230 days to obtain the certificate. As she shared the company’s experience she pointed out that most of the attention shall be paid to the preparation stage, as any inaccuracy will increase time and cost demands

In 2022 new rules based on Eurasian Economic Union protocol will come in force in Russia for the registration of medical appliances, this protocol is stricter in terms of requirements to the documents.

  • The list of documents to be submitted for application will increase threefold as compared to currently required 11 documents and an application itself.
  • Another new mandatory requirement will be to submit the registration documents in at least two countries of EEU. One can choose between Armenia, Kazakhstan, Kirghizia, Belarus and Russia. The fee will be charged for each application separately;
  • Within two years after the registration, safety reports on the use of sold appliances will need to be submitted to Federal Service for Surveillance in Healthcare;
  • Operation manual will need to be translated into the languages of all EEU countries where the registration is planned.

To have enough time for registering a medical appliance before the rules update, startups should start the procedure before May 2021.

Source: Media Office of TechnoSpark

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