«Regfort» is the first registration agency with concierge service. We register your medical products (including in vitro diagnostics) and you enjoy the process! 100% result guarantee.

Protected by «Regfort»
throughout the registration path.

RUS
«Regfort» is the first registration agency with concierge service. We register your medical products (including in vitro diagnostics) and you enjoy the process! 100% result guarantee.

Protected by «Regfort»
throughout the registration path.
RUS
Regfort has been helping its clients to make medical registration easy and pleasant for more than 3 years. During this time, the company's portfolio was supplemented by 30 successful deals.
About the company
With us you can be sure that after passing all stages you will receive a registration certificate. In addition, in rare cases of refusal we do not charge for re-application.
100% RESULT
We will sign for you a detailed path for each process taking into account possible delays. You will receive a commercial offer with personal tracking.
TRANSPARENCY OF PROCESSES
Each client we provide a personal assistant, a guardian angel. He will accompany you throughout the journey. Your assistant will have only one area of responsibility – you, from the collection of documents to the patent.
CONCIERGE SERVICE
YOUR COMPANY
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100% RESULT
Professional level engineers and reliable contractors are the main factors in how quickly you get a registration certificate. That's why at "Regfort", every specialist is picked up with jewelry accuracy.
How do we do it?
  • We work with equipment and products of any complexity and country of origin
  • We write technical documentation from scratch, involving engineers With work experience from 8 years
  • We are against the "streaming" mode of operation. Engineer leads no more than three customers at a time to approach each case as closely as possible
  • We have an exhaustive knowledge of the rules and specifics of Federal Service for Surveillance in Healthcare work. This registration is not at random, but for sure. We quickly receive information about changes in rules and immediately take them into account in our work
  • We work with the tested laboratory, which for 10 years is headed by an employee of Federal Service for Surveillance in Healthcare. This laboratory has never had failures and comments from registering bodies
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Back
100% RESULT
Professional level engineers and reliable contractors are the main factors in how quickly you get a registration certificate. That's why at "Regfort", every specialist is picked up with jewelry accuracy.
How do we do it?
  • We work with equipment and products of any complexity and country of origin
  • We write technical documentation from scratch, involving engineers With work experience from 8 years
  • We are against the "streaming" mode of operation. Engineer leads no more than three customers at a time to approach each case as closely as possible
  • We have an exhaustive knowledge of the rules and specifics of Federal Service for Surveillance in Healthcare work. This registration is not at random, but for sure. We quickly receive information about changes in rules and immediately take them into account in our work
  • We work with the tested laboratory, which for 10 years is headed by an employee of Federal Service for Surveillance in Healthcare. This laboratory has never had failures and comments from registering bodies
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Back
CONCIERGE SERVICE
Would you like your personal, attentive and prudent guardian angel nearby? "Regfort" will appoint you exactly that kind of assistant. His task is to protect your interests before Federal Service for Surveillance in Healthcare throughout the registration path, responding promptly to any emerging issues. The angel has only one area of responsibility — you, from the collection of documents to the patent.
Pluses:
  • Guardian angel is always in touch
  • He knows your case in the smallest detail
  • You have one entry point, not a group of people to contact for different questions
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Back
CONCIERGE SERVICE
Would you like your personal, attentive and prudent guardian angel nearby? "Regfort" will appoint you exactly that kind of assistant. His task is to protect your interests before Federal Service for Surveillance in Healthcare throughout the registration path, responding promptly to any emerging issues. The angel has only one area of responsibility — you, from the collection of documents to the patent.
Pluses:
  • Guardian angel is always in touch
  • He knows your case in the smallest detail
  • You have one entry point, not a group of people to contact for different questions
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Back
TRANSPARENCY OF PROCESSES
Feel confident and safe — stay up to date! It will spare you unnecessary questions, doubts and unrest. Therefore, registration from a difficult procedure will turn into an understandable process.
We 're doing the job, but you 're at the helm!
  • You will receive detailed estimates that include the real cost of our services, laboratories and other contractors
  • You do not have to pay surcharge in addition to the cost of laboratory services. Settle with them directly at a special price! There's even a discount for you
  • Track the process in your personal office by tracking. Learn about all the changes in real time
  • We will guide you until the documents are received and will not charge for re-application if registration is refused (this is very rare!)

Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Back
TRANSPARENCY OF PROCESSES
Feel confident and safe — stay up to date! It will spare you unnecessary questions, doubts and unrest. Therefore, registration from a difficult procedure will turn into an understandable process.
We 're doing the job, but you 're at the helm!
  • You will receive detailed estimates that include the real cost of our services, laboratories and other contractors
  • You do not have to pay surcharge in addition to the cost of laboratory services. Settle with them directly at a special price! There's even a discount for you
  • Track the process in your personal office by tracking. Learn about all the changes in real time
  • We will guide you until the documents are received and will not charge for re-application if registration is refused (this is very rare!)

Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
«Regfort» will help you avoid registration errors – in the end you will save money and speed up the registration procedure as much as possible.
Our services
Registration of medical products of Russian and foreign production.
State registration of products in vitro diagnostics with full support.
Development of technical and operational documentation.
Registration of medical products within the EAEU. Full support of the state registration process in five countries: Russian Federation, Belarus, Kazakhstan, Armenia, Kyrgyzstan.
VIRD – Amendment of registration documents.

VIRU – Make changes to the registration certificate.
Preparation:
1. Files for duplicate issuance and replacement of registration certificates
2. Certificate and Declaration of Conformity Documents
3. Files for licensing production
Registration
In vitro
diagnostics
Technical documentation
Registration within EAEU
VIRD & VIRU
Preparation
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Technical Translation
Laboratory Testing
more
Subtracting and editing text
Based on the technical documentation compiled by Regforth engineers, we will create an instruction for the end-user: buyers and doctors. Do you want its form and content to be at the highest level? Give it to our literary editor. Not only does it subtract text for unfortunate typos, but it will also work out the style, submission and accessibility of information to the reader. Everything must be fine in your product!
Digital instructions
According to the new legislation (reference to the law), it is necessary to post all instructions on the Internet, as well as on the portal of the EAEU. We'll help you with that!


Printing house
You can order the shooting, retouching and printing of medical photographs for the registration file.
Marketing advance
Thanks to the experienced team of our specialists, you can enter the market not only with registration, but also ready for sale product. The package of services includes: market analysis, positioning, naming, corporate style, packaging design, website. As well as bringing the product to the digital market (strategy of promotion through Internet advertising: context and social networks).

Do you want to be part of a large holding? We know how to prepare documents and a presentation for the sale of the project to the investor.
Subtracting and editing text
Based on the technical documentation compiled by Regforth engineers, we will create an instruction for the end-user: buyers and doctors. Do you want its form and content to be at the highest level? Give it to our literary editor. Not only does it subtract text for unfortunate typos, but it will also work out the style, submission and accessibility of information to the reader. Everything must be fine in your product!
Digital instructions
According to the new legislation (reference to the law), it is necessary to post all instructions on the Internet, as well as on the portal of the EAEU. We'll help you with that!
Printing house
You can order the shooting, retouching and printing of medical photographs for the registration file.
Marketing advance
Thanks to the experienced team of our specialists, you can enter the market not only with registration, but also ready for sale product. The package of services includes: market analysis, positioning, naming, corporate style, packaging design, website. As well as bringing the product to the digital market (strategy of promotion through Internet advertising: context and social networks).

Do you want to be part of a large holding? We know how to prepare documents and a presentation for the sale of the project to the investor.
Review
LLC «BMB Trading House» thanks «Regfort» for fruitful cooperation and full support of the process of state registration of medical products, as a result of which the following registration certificates were obtained:
• RP complete № FSSH2017/6038 dated 04.08.2017 for the medical product "Biopsy disposable needles for oncology and hematology"
• 35360 FHS 2012/12853 dated 14.05.2019 for medical product "Medical tools and devices for kyphoplasty and vertebroplasty in sets and individual packages"
• FHS 2010/06121 dated 21.02.2017 for medical product "Catheters in sets and separate packages with accessories for anesthesiology"

We recommend «Regfort» as a trusted and professional partner, successfully executing all arrangements on time.
LLC «BMB Trading House» thanks «Regfort» for fruitful cooperation and full support of the process of state registration of medical products, as a result of which the following registration certificates were obtained:
• RP complete № FSSH2017/6038 dated 04.08.2017 for the medical product "Biopsy disposable needles for oncology and hematology"
• 35360 FHS 2012/12853 dated 14.05.2019 for medical product "Medical tools and devices for kyphoplasty and vertebroplasty in sets and individual packages"
• FHS 2010/06121 dated 21.02.2017 for medical product "Catheters in sets and separate packages with accessories for anesthesiology"

We recommend «Regfort» as a trusted and professional partner, successfully executing all arrangements on time.
On behalf of LLC «Bayopsi Diagnostics» we want to express gratitude to the company «Regfort» which successfully carried out the process of obtaining the following registration certificates:
• № FHS 2010/06121 dated 21.02.2017 for medical product "Catheters in sets and separate packages with accessories for anesthesiology"
• № FSSH 2019/9405 of 19 December 2019 for the medical product "Needles for soft tissue biopsy disposable guillotine"
• № FSSH 2019/9402 of December 19, 2019 for the medical product "Biopsy single-use aspiration-histological needles in separate packages"

Among other things, we received permission
for clinical trials of the medical product
"Pre-operational localizer needles."

Based on successful and productive cooperation experience, we recommend «Regfort».


The pharmaceutical company LLC "Satius" thanks the company «Regfort» which is engaged in full support of the process of state registration of medical products and medical equipment, for successful cooperation and receipt of positive conclusions on the procedure of VIRD in three months. We recommend «Regfort» as a reliable counterparty, fulfilling its obligations, and specialists of the company as highly qualified experts in the field of registration of medical products.
LLC «Kolechko», a company producing dental equipment, thanks «Regfort» for successfully accompanying in the process of state registration of medical products. «Regfort» certified specialists have demonstrated extensive experience and competence in matters related to the registration process. We would like to express our special gratitude for the individual approach to the work and personal interest in solving issues arising in the process of development of technical documentation. Based on the positive and productive experience of cooperation, LLC «Kolechko» recommends the services of «Regfort».
Review
Registration of medical product –
step-by-step.
Registration process
Analysis of your medical product – free of charge
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
What is included in the analysis:
• Calculation of registration time
• Calculation of the cost of services by phase, by time. Enables selection of required studies
• Determination of the risk class of the product
• Selection of registered analogue of medical work: type, class, number of registration certificates (whether one will suffice for all components of the product or several separate ones will be required)
• Compilation of a list of competitors – analogues of your medical product on the market, with indication of their registration certificates
What is included in the analysis:
• Calculation of registration time
• Calculation of the cost of services by phase, by time. Enables selection of required studies
• Determination of the risk class of the product
• Selection of registered analogue of medical work: type, class, number of registration certificates (whether one will suffice for all components of the product or several separate ones will be required)
• Compilation of a list of competitors – analogues of your medical product on the market, with indication of their registration certificates
Analysis of your medical product – free of charge
Order a free audit of your product now! This does not oblige to anything, but allows to make sure of the quality of our services
Question-answer
Everything needs to be registered? From gloves to mobile X-rays?
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".
Do you need to register medical software, too? What?
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.
And why does the registration procedure take from 6 months?
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.
What laboratory tests are you doing?
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.
In 2021, the deadline for registration of all medical equipment and products expires. What then? Need to re-register?
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.
Why not everyone takes the registration of products for in vitro diagnostics?
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"!
Why are registration services so expensive?
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 — 45 000 rubles
  • Class 2a — 65 000 rubles
  • Class 2b — 85 000 rubles
  • Class 3 — 115 000 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.
And why do some offer cheap and fast?
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.
Why is the assignment of a risk class in the Russian Federation different from other countries?
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.
Who should be the authorized representative at the registration? Can Regfort be one?
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.
What is the procedure for changing the name of a product, manufacturer or place of production during the registration process?
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.
What is the procedure for changing the product name if I already have a registration certificate?
This procedure is called VIRD and according to regulation 1416 p 37−38 is decided individually. What does it mean?
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.
Which companies and organizations should be listed in registration certificate?
Manufacturer, developer, applicant, authorized representative of manufacturer in Russia and place of production.
What documents do we make?
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.
What products have you already registered?
It is more than 100 names. If you need an accurate list, ask the Regfort manager — info@regfort.com
«Regfort»
Moscow, Raushskaya quay., 4/5

Phone:
+7 925 313-76-47
+7 499 702-58-78

E-mail: info@regfort.com
Protected throughout the registration path
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