Аккредитация на регистрацию по правилам ЕАЭС
Наличие собственной испытательной базы
Богатый опыт наших специалистов
Регистрация медицинских изделий под ключ
It may take as long as 18 to 24 months to get a medical device registered and be issued a registration certificate if the procedure is performed on one’s own. Medalis offers a turnkey solution for prompt and secure registration of medical devices. We will manage the gathering of documents, testing by an accredited laboratory, logistics support and customs clearance, and will help you get the medical device registered under the EAEU regulations.
A registration certificate for a medical device is a document confirming that a particular medical product is included in the State Register of Medical Devices and can be freely manufactured in or imported to the Russian Federation for its subsequent sale and use. Both Russian and foreign companies registered under the current laws of the Russian Federation can be issued a registration certificate.
According to Decree No. 1416 of the Government of the Russian Federation dated December 27, 2022 “On Approval of the Rules for State Registration of Medical Devices”, any tools, equipment, materials and other products, as well as other fixtures and software intended for medical applications (hereinafter referred to as “medical devices”) are subject to state registration.
The manufacture, sale and use of medical devices without a registration certificate are penalized by suspension of business and imprisonment of the responsible person or by a fine of up to 2 million rubles.
The Federal Service for Supervision of Healthcare (Roszdravnadzor) issues registration certificates in accordance with regulations of the Eurasian Economic Union (EAEU). In the EAEU member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia), registration certificates are valid for an indefinite period. As of January 1, 2022, registration under national regulations of the EAEU member states was terminated.
Cost of obtaining a registration certificate | Cost of obtaining a registration certificate | Cost of obtaining a registration certificate |
Cost of obtaining a registration certificate | 50 000 RUB |
The first step in the preparation for registration of a medical device is to identify its risk class. Also, particular attention needs to be paid to the complexity of design of the medical device, its intended use, number of available versions, and so on. The higher the risk class of a medical device is, the more time and effort it requires, leading to the increase of duration and overall cost of our work.
Classes of medical devices:
Both the amount of state fees and the cost of expert services for evaluation of efficacy, quality and safety vary depending on the risk class. Registration takes up to 10 months for Class 1, up to 14 months for Class 2a, and up to 16 months for Classes 2b and 3.
Domestic manufacturers of medical devices are to provide the following documents for the purposes of obtaining a registration certificate:
For medical devices manufactured abroad, the following documents are to be provided for the purposes of obtaining a registration certificate:
Documentation for foreign-made medical devices must be provided with a notarized translation..
Medalis assists both Russian and foreign manufacturers of medical devices in obtaining registration certificates. If you have no opportunity or time to study the legal framework, search for a laboratory, or coordinate details with Roszdravnadzor, we can:
Medalis is a member of Eleсtrontest Group that has been present on the market of medical devices for more than 12 years. The Group comprises laboratories that perform technical, clinical diagnostic, and toxicity testing and have a confirmed status from the Federal Accreditation Service. We cooperate with research organizations that test products from Boston Scientific, Mindrey, and Johnson. We offer a transparent registration process, convenient working arrangements with a personal expert, and reduced registration costs, and will make sure you receive a registration certificate at the first attempt.
The Elecrontest Group of Companies has been operating in the medical device circulation market for more than 10 years. During its existence, more than 600 registration certificates have been successfully obtained.