Protected by «Regfort»
throughout the registration path.

Yes, you need to register absolutely all medical products. Here what tells Federal law № 323-FZ "About bases of protection of public health in the Russian Federation": "Medical products are any tools, devices, devices, the equipment, materials and other products applied in the medical purposes separately or in a combination among themselves and also together with other accessories necessary for application of the specified products to destination".

Yes, such software has recently been considered a medical product. And not only complex software for special equipment, but also, for example, databases in clinics. Do you use unregistered ON? Any inspection can result in large fines. We register medical software with a result guarantee.

As a rule, registration is long. You look:

• 2-3 months for collection of required documents and preparation of documentation with the client
• 2-3 months for laboratory research
• 3-4 months for consideration of the case in Federal Service for Surveillance in Healthcare

That's why companies promising you ready-made registration in a couple of months are luring trying to get a customer at all costs. They expect that, after tons of documents, you will no longer want to abandon what you have started. And perhaps you just have scams in front of you who will disappear immediately after bail is made. Be careful.

All necessary for registration and certification: toxicological, technical and clinical.
1. Toxicological — prove that materials and substances used in the formula are safe
2. Technical — prove that the product meets the requirements of the specification and operational documentation of the manufacturer by its properties and technical characteristics, as well as that the production process will be uniform and it will not be necessary to check each individual element of the batch
3. Clinical — confirm effectiveness and safety of medical task solution

We 've only been working with proven laboratories for four years. At the same time, without adding your commission to the cost of their work — you pay the laboratories directly.

Yes, December 31, 2021 — the last day of validity of the current rules of registration of medical products in the Eurasian Economic Union countries (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan).

All medical products used in the markets of the Eurasian Economic Union member states under local rules will require full registration under the new union rules after December 31, 2021. For this producers are given 5 years.

Unfortunately, without this procedure you will not be able to sell your equipment and products within the framework of the Eurasian Economic Union. And doctors will not be able to prescribe and use unregistered products.

We also advise you not to wait for a possible collapse in late 2021-early 2022. After all, the average period of bringing medical products to the Eurasian Economic Union market by new rules (taking into account all new tests and registration procedure) can be from a year to two.

Rare laboratories can conduct qualitative tests of reagents, test systems, nutrient media, and control materials for in vitro diagnosis. Developing technical and operational documentation for such products is also a difficult task. But we know how to solve it on "excellent"!

Here are the main items of expenditure:
1. State fees of Federal Service for Surveillance in Healthcare
State registration of medical product — 7,000 rubles.
Making changes to the registration certificate for the medical product — 1500 rubles.
Issuance of a duplicate registration certificate for a medical product — 1500 rubles.
Carry out an examination of the quality, efficiency and safety of medical products depending on the risk class.

• Class 1 — 72 000 rubles
• Class 2a — 104 000 rubles
• Class 2b — 136 000 rubles
• Class 3 — 184 000 rubles

2. The work of an engineer who develops documentation. This is a very important point, because any mistake delays you for a few months and once again forces you to pay duties.

3. Payment of laboratory researches. The amount depends on the product you 're testing.

Unfortunately, the market is flooded with frauds. If you are offered registration in a couple of months or worth less than 500 thousand rubles, do not believe. After all, it is simply impossible to meet this amount based on expenditures on state duties and laboratory research. And two months will not be enough even to consider the case of Federal Service for Surveillance in Healthcare.

On average, the dossier spends 4 months in Federal Service for Surveillance in Healthcare. This is due to the large flow as well as the three stages of comments. First they check the legal part. Then the case passes to Center for Monitoring and Clinical and Economic Expertise or All-Russian Research and Testing Institute of Medical Engineering, here there is a technical check. Often the third stage is clinical trials. And the most difficult thing is technical, but «Regfort» has cases where we got a case without comment.

Cases where you are offered to "buy" a registration card are particularly dangerous. Remember that all cases are checked by security structures. And since the file is filed on your behalf, it is you, not the frauds, who will be brought to justice.

Russia has its own legislation. Risk class is assigned on the basis of order dated June 6, 2012 N 4n. And in addition, we analyze previously registered analogues (no more than 2 years) to make sure that we have correctly selected the risk class.

The Authorized Representative of the Producer (ARP) in the territory of the Russian Federation (RF) is the organization or the individual entrepreneur who are residents of Russia. Therefore, it can become your Russian distributor or us. You can change the ARP at any time, this procedure takes 2−5 months.

We can change both the name of the medical product and the place of production at any stage of registration for an additional fee. Depending on the registration stage (about 30), the set and content of documents changes. After that we send you prepared papers for apostillation and notarization. The next stage — we provide the documents approved by you to Federal Service for Surveillance in Healthcare.

For a detailed chart of work, contact our employees to prepare a customized timeline for you with a list of documentation.

In order to estimate the scope of work and documents, you need to see your registration certificate and the reasons for the changes. Unfortunately, there is no single formula, but "Regfort" carries out such analysis free of charge, which makes life easier for clients.

Manufacturer, developer, applicant, authorized representative of manufacturer in Russia and place of production.

All known for Russian legislation that you may need during the registration process. After analyzing the product, we will send you a list of documents you will need.

It is more than 100 names. If you need an accurate list, ask the Regfort manager — info@regfort.com

The reduced tax rate of 0 or 10%, depending on the product type applies until December 31, 2022. To be granted the said rate, you need to provide Russian registration certificates to the tax authority. Afterwards the reduced rate is grated only if your medical device is registered according to the EAEU rules.
Draft Federal Law "On Amendments to Articles 149 and 164 of Part Two of the Tax Code of the Russian Federation (in terms of taxation (exemption from taxation) of medical goods)".