Registration of medical devices in Roszdravnadzor
Registration of medical devices in Roszdravnadzor – is a procedure that allows the production and circulation of high-quality and safe medical devices on the Russian market.
A registration certificate for a medical device – is a document issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and gives the official right to manufacture or sell medical devices.
The procedure for registration of medical devices in Roszdravnadzor was approved by the Government of the Russian Federation No. 1416 of December 27, 2012.
The form of the registration certificate and the data indicated in it were approved by order of Roszdravnadzor No. 40-Order/13 dated January 16, 2013.
- What is a medical device?
- Hazard classes of medical devices;
- Documents required for registration of a medical device;
- State duty for the registration of a medical device;
- The process of registering a medical device with Roszdravnadzor;
- The advantages of working with our company;
- Cost and term of registration of a medical device with Roszdravnadzor;
- Stages of payment for services for registration of a medical device;
- Responsibility for the lack of a registration certificate.
The term medical device was approved on January 1, 2013, and previously such products were referred to as “medical devices” and “medical equipment”.
The hazard class of a medical device – is a conventional value used for a simplified classification of medical devices according to the degree of potential risk.
There are four hazard classes in total:
- Hazard class 1 – medical devices with a low degree of risk;
- Hazard class 2a – medical devices with an average degree of risk;
- Hazard class 2b – medical devices with an increased degree of risk;
- Hazard class 3 – medical devices with a high degree of risk.
A medical device can only be classified in one hazard class.
If a medical device consists of several components, and each of them has a different hazard class, then the entire medical device is assigned a hazard class according to the highest hazard class of the components.
* For an exact definition of the hazard class of a medical device, please contact us.
We request a minimum set of documentation to launch a project.
In the process of registering a medical device with Roszdravnadzor, our experts develop the missing documents.
- The document on the registration of the manufacturer as a legal entity (in the country of production);
- Manufacturer’s conformity certificates;
- Medical device approval documents;
- Apostilled power of attorney for a representative (applicant) in the Russian Federation;
- ISO-13485 quality management certificate;
- Technical file for a medical device;
- Production flowchart (in case it is not displayed in the technical file);
- Operational documentation of a medical device: for example, instructions for use or operating instructions;
- Photos of medical device.
* In the absence of the necessary documents for a medical device, the experts of the Goszdravnadzor company will develop them during the registration process without additional payment from your side!
- Hazard class 1 — RUB 83,000 (examination + registration certificate form);
- Hazard class 2a — RUB 115,000 (examination + registration certificate form);
- Hazard class 2b — RUB 147,000 (examination + registration certificate form);
- Hazard class 3 — RUB 195,000 (examination + registration certificate form).
The amount of the state duty for the registration of a medical device with Roszdravnadzor is established by Article 333.32.2 of the Tax Code of the Russian Federation.
- We analyze the available technical documentation, clarify the purpose and technical characteristics of the medical device, check the analogues of already registered medical devices;
- We determine the hazard class of a medical device according to the degree of potential risk of use;
- We obtain an import permit for a medical device (for foreign manufacturers);
- We are finalizing (developing) a technical file for a medical device;
- We provide translation of design and operational documentation into Russian (if necessary);
- We check the completeness of the normative and technical documentation and form a package of documents for carrying out the necessary tests;
- We select testing laboratories (the types of tests depend on the medical device);
- We carry out tests in accredited testing laboratories (technical and toxicological);
- We form a package of documentation (prepare the primary registration dossier) and coordinate it with Roszdravnadzor;
- We issue a request and receive a referral for clinical trials;
- We conduct clinical trials in a specialized organization and get a positive decision on them;
- We provide state registration of a medical device in Roszdravnadzor;
- We send the generated package of documentation to an expert organization;
- We receive the original registration certificate and a positive decision of Roszdravnadzor (a copy of the order on the registration of a medical device);
- We send a complete set of documentation to the customer along with a registration certificate for a medical device.
All stages of work on the registration of medical devices are indicated in the contract with our company:
Please note: many mediators for registration of medical devices hide some of the stages of work, thereby misleading their clients! There are many cases when unscrupulous «registrars» entered into a contract for the provision of services, and then brought the final cost of work to disproportionately high figures.
Look at our company in comparison with competitors:
Companies-competitors Company Goszdravnadzor The work is carried out by sales managers, call specialists, lawyers, accountants and anyone else except trained employees Registration of medical devices is carried out by experts with specialized education and knowledge of a foreign language Accompanying the registration of a medical device follows a template, according to pre-prepared forms of documents, without deep penetration into the essence of the process and the device of a medical device, which often leads to refusals to register a medical device Registration of medical devices takes place taking into account the individual characteristics of the medical device, the technological process and the principle of operation. We develop missing documentation ourselves The testing ends with the transfer of the customer’s contacts to the testing laboratory without further control of the testing The entire testing process is controlled by us. After the tests, if necessary, we amend the protocols for their successful adoption by Roszdravnadzor Communication with the customer is carried out during working hours and only by E-mail, which significantly extends the period of registration of a medical device Any way of communication, convenient for the customer, is welcomed. We communicate directly with the manufacturer in a foreign language The cost of work often increases due to the sudden «additional development of any documents» The exact cost of our services is known in advance, is fixed in the contract and remains unchanged until the completion of the project There is a high probability of reaching an intermediary, which will significantly increase the time and cost of work to support the registration of a medical device. «Broken phone» effect appears
We work directly with state authorities. We independently modify the documentation and transfer the dossier (not by mail, but personally into the hands of the employees of Roszdravnadzor) There are no guarantees to support the registration of a medical device in Roszdravnadzor We provide a guarantee for the successful registration of a medical device. Otherwise, we return all losses.
The term for registration of a medical device is up to 7 months.
The term for registration of a medical device is up to 9 months.
The term for registration of a medical device is up to 11 months.
The term for registration of a medical device is up to 14 months.
If part of the documentation for a medical device has already been prepared, and some stages of registration have been successfully completed, then the time and cost of the work are reduced. To receive a commercial offer for the registration of your medical device, please contact us!
* In addition to the registration certificate of Roszdravnadzor for a medical device, you may need a certificate of conformity.
Registration of medical devices with Roszdravnadzor is a rather long procedure. For the convenience of distributing the budget of our customers, payment for services is made in several stages:
- 30% – after the conclusion of an contract with our company for the implementation of a project for the registration of a medical device in Roszdravnadzor;
- 30% – after the start of technical and toxicological tests of a medical device in the laboratory;
- 30% – after receiving official permission to conduct clinical trials;
- 10% – after registration of the medical device with Roszdravnadzor and receipt of the original registration certificate.
* If necessary, it is possible to agree on individual terms of payment for you.
The full price list for the provision of services by our experts is here.
The cost of work on the registration of the registration certificate of Roszdravnadzor does not include the state duty and the cost of services for conducting the necessary tests (technical, toxicological and clinical). The tests are paid by the Customer directly according to the invoices from the laboratories, and the state duty is paid according to the requisites of Roszdravnadzor. In the process of work, the experts of our company select the necessary indicators and standards for testing in accredited laboratories.
To receive a commercial offer for the registration of your medical device with an indication of the services for conducting tests, please contact us!
The Federal Law «On the Basics of Health Protection of Citizens in the Russian Federation» No. 323-FZ states that the use of medical devices with a valid registration certificate of Roszdravnadzor is permitted on the territory of the country.
The registration procedure for medical devices is mandatory by law, and fines for the sale of such devices without a registration certificate can amount to several million rubles. Liability, up to criminal, is provided for by Articles 6.28, 6.33 of the Administrative Code of the Russian Federation and Article 238.1 of the Criminal Code of the Russian Federation.
Since 2011, the Goszdravnadzor team has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction to the smallest nuances. And today we confidently declare that we are one of the leaders in the design and development of permits for medical devices!
Benefits of cooperation with Goszdravnadzor:
A team with a single goal
The Goszdravnadzor company is an organism united by a common goal — to do the work so that the client is satisfied, turns to us again, and advises colleagues and friends. An optimally selected staff of employees successfully solves any tasks in the implementation of projects, moreover, they do it without involving other performers. Our client will never «lose» his project manager since we do not have a staff turnover.
In words, in contracts and in work
The obvious superiority of the Goszdravnadzor company over its competitors is transparent and honest interaction with the customer. After receiving a commercial offer, you can be sure that the prices and terms for the provision of services in it are final. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages — upon completion of the work.
Guarantee of successful project execution
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for a medical device. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and shorten the time it takes to complete the work.
Experience, knowledge and authority.
Since 2011, Goszdravnadzor has been implementing projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, carry out tests the first time, and develop documentation without a headache for the customer.