For carrying out the activities of production and technical maintenance of medical equipment in Russia, any organization or individual entrepreneur needs to obtain Roszdravnadzor’s license for production and technical maintenance of medical equipment.
Starting from 01.01.2021 the procedure of production and technical maintenance of medical equipment licensing is regulated by the Government Decree of the Russian Federation dated from September 15, 2020.
Our company provides services of Roszdravnadzor’s license obtaining and its renewal all over the territory of the Russian Federation for more than 10 years. Apply for the application order form to obtain license, using a service order application form:
| 1 |
Medical devices registration in Rosdravnadzor including the requirements of the EEU
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We will develop technical documentation, organize testing, prepare and trace the registration dossier |
| 2 |
Package of documents preparation for positive licensing in Roszdravnadzor. |
Urgently and confidentially. |
| 3 |
Advanced training certificates obtaining, expert qualification certificates, retraining diplomas and other documents on education. |
remotely, by correspondence, urgently. |
| 4 | Lease of measuring equipment and/or assistance in its purchase. |
we will rent or assist to purchas |
| 5 |
Quality management system development according to GOST ISO 13485-2017.Obtaining a certificate GOST ISO 13485-2017. |
Urgently and confidentially |
| 6 | Conducting a special assessment of labor conditions |
Urgently and confidentially |
| 7 |
One-time expertise documents. Prelicensing consulting. |
The provision of the service is possible using any means of communication, as well as at a personal meeting in our office or your territory. |
| 8 |
Post licensing activities support. Audit of the implementation of licensed activities. |
confidentiall |
The procedure of production and technical maintenance of medical equipment licensing is regulated by the Government Decree of the Russian Federation dated from September 15, 2020.
The license is issued by the Federal Service for Surveillance in Healthcare, the abbreviated name is Roszdravnadzor The license is valid for an unlimited period. The term for obtaining a license by an applicant is up to 45 working days.
The license is issued for a general type of production and technical maintenance activities (with the exception if technical maintenance is carried out to provide juridical entity’s personal or individual entrepreneur’s needs) of medical equipment. In the license itself, depending on the work carried out, it is indicated in which type of activity the document is issued, namely:
| 1 |
In the production of medical equipment. |
| 2 |
In the technical maintenance (with the exception if technical maintenance is carried out to provide juridical entity’s personal or individual entrepreneur’s needs) of medical equipment. |
Medical device manufacturer – juridical or physical entity registered as an individual entrepreneur is responsible for medical devices development and production making it available for use on their own behalf, regardless of whether the medical device is designed and (or) manufactured by this person or on his behalf by another person (s), and are responsible for the safety, quality and effectiveness of the medical device.
Roszdravnadzor’s license for medical equipment production can obtain as medical device direct manufacturer (manufacturer’s authorized representative) so as the license applicant which concluded an agreement with direct manufacturer regarding production and including the questions of ensuring quality control and safety of the performed devices and the responsibility before 3rd parties.
In case if the license is obtained not by direct manufacturer (manufacturer’s authorized representative), but an applicant which concluded an agreement with the manufacturer then an additional production site should be indicated in Roszdravnadzor Registration certificate for performed medical device.
Production facility – geographically separated area designed to perform the entire process of manufacturing of a medical device or its specific stages .
There is no need in getting through Roszdravnadzor licensing procedure to manufacture medical equipment of 1st class of risk.
However production companies should take into consideration the requirements for carrying out such corresponding activities regulated by the normative (technical) documentation for the manufactured medical device in terms of the availability of the necessary equipment, premises, qualified personnel.
It is also necessary to implement quality management system created and functioning with the compliance to the requirements of the interstate standard GOST ISO 13485-2017.
The license for medical equipment production is possible to obtain for only registered medical device.
The whole scope of manufactured on the territory of the Russian Federation medical equipment is the subject of the state registration in Roszdravnadzor as according to the national Russian requirements, so as according to the EEU registration requirements.
One of the main licensing package of documents is medical device Roszdravnadzor registration certificate.
It is also necessary to provide technical documentation: technical conditions, manual.
To obtain a license, non-residential premises, building, structure belonging to the license applicant on the right of ownership or on another legal basis at the place of implementation of the licensed type of activity is suitable. There are no special requirements revealed related to the equipment of the premises.
However, taking into account the sanitary and epidemiological requirements for the norm of the area of the premises per employee from 4.5 square meters to 6 square meters, the obligatory special assessment of working conditions, the area of premises must be calculated based on the number of employees.
Also, the space must comply with the production processes reflected in the technical specifications, the quality management system. It is necessary to take into consideration the requirements for the performance of the relevant work, regulated by the regulatory (technical) documentation for the manufactured medical device in terms of the availability of the necessary equipment, qualified personnel, specialized premises in which the products are directly produced or stored finished and rejected products or spare parts. The following premises are not suitable for the licensing: attics, basements, basement floors, underground rooms, ventilation chambers and other premises of technical purposes.
To obtain a license for medical equipment production, you must have at least two employees engaged in the medical equipment production process:
| 1 | Who have concluded employment contracts with license applicants |
| 2 |
With higher or secondary vocational (technical) education |
| 3 |
With higher or secondary vocational (technical) education |
| 4 |
With additional professional education (advanced training at least once every 5 years), corresponding to the performance of work and the provision of services. |
If besides the type of activity «medical equipment manufacturing» in the license will be indicated the type of activity «technical maintenance», then depending upon the quantity of serviced types of medical equipment (works, services) the requirements are established for the presence of a certain staff, suitable for licensing employees :
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When performing one or two types of work (services) |
Not less than 2 persons |
| When performing three or four types of work (sevices) | Not less than 3 persons |
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When performing five and more types of work (services) |
Not less than 5 persons |
For licensing the production of medical equipment, the list of measuring equipment is established by the technical conditions and operational documentation for medical equipment, which the license applicant intends to produce in the future. Measuring equipment must have a valid inspection certificate. In addition to the data on the measuring equipment, information is provided on the availability of aids and tools. Besides the data for the measuring equipment it is also considered to provide information on the availability of aids and tools.
A mandatory requirement for the implementation of activities for medical equipment production is the availability of a quality management system created and functioning according to the requirements of the standard GOST ISO 13485-2017.
The experts of Roszdravnadzor are extremely strict about the implementation of the specified license requirement\condition. The Decree on licensing spelled out a rule on the possibility of involving Roszdravnadzor in organizing and carrying out licensing control of experts from expert organizations accreditied in the prescribed manner.
Organizations that have licenses for the maintenance of medical equipment obtained according to the requirements of the expired Resolution № 469 dated from 03.06.2013 are obliged to confirm compliance with the requirements for the availability of a quality management system created and functioning according to the requirements of the GOST ISO 13485-2017 standard, including protocols of certification and (if any) inspection (s) audit (s).
| 1 |
Copies of constituent and registration documents; |
| 2 |
Payment order for payment of state fees 7500,00 roubles (link) |
| 3 |
Copies of documents confirming ownership or other legal basis for the use of premises for the implementation of licensed activities; |
| 4 |
Data on material and technical equipment availability; |
| 5 |
Technical conditions on manufactured medical equipment |
| 6 |
Registration certificate on manufactured medical equipment |
| 7 |
Production control program |
| 8 |
Operational documentation on medical equipment under maintenance; |
| 9 |
The list of working staff corresponding to the licensed requirements; |
| 10 |
Documents details confirming the availability of designed and functioning quality management system according to the GOST ISO 13485-2017. Certificate GOST ISO 13485-2017 |
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Power of attorney for submission of documents; |
| 12 |
Application form |
| 13 |
Inventory |
We will provide all the necessary services for customers intending to start the procedure of license obtaining for medical equipment maintenance from «Zero point level»:
| 1 STEP | We will registrate juridical entity or individual entrepreneur status |
| 2 STEP | We will open a current account |
| 3 STEP |
We will registrate a medical purpose device |
| 4 STEP |
We will assist to find appropriate premises |
| 5 STEP |
We will find experts and train them |
| 6 STEP |
We will assist to purchase and rent the equipment |
| 7 STEP |
We will develop quality management system according to the GOST ISO 13485-2017and obtain the certificate GOST ISO 13485-2017. We will prepare the whole set of the necessary documents for the licensing procedure |
| 8 STEP |
We will carry out Roszdravnadzor on-site check |
| 9 STEP | License obtaining |
All the licenses for medical equipment production and maintenance obtained with the compliance of the requirements of the Resolution № 469 dated 03.06.2013 are the subject to renewal with the compliance of the requirements of acting Regulation №1445 dated 15.09.2020 up to 31.12.2023.
If there is an Appendix in the license regarding the implementation of activities in the field of technical maintenance of medical equipment, licensees are obliged to reissue the licensed, taking into account the group of medical equipment by classes of potential risk of use and other licensing requirements.
For the license renewal procedure the following reasons are considered
| 1 |
in case of carrying out juridical entity reorganization procedure in the form of transformation; |
Renewal term of 10 working days |
| 2 |
in case of juridical entity name change, individual entrepreneur name change, actual location address; |
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| 3 |
In the event of a change in the addresses of places where legal entity or an individual entrepreneur carries out a licensed type of activity, the list of work performed, services provided that constitute the licensed type of activity. |
Renewal term of 30 working days |
| 4 |
Termination the activity at one of the addresses |
Renewal term of 10 working days |
The list of the documents on the license renewal in case of carrying out juridical entity reorganization procedure in the form of transformation in case of juridical entity name change, individual entrepreneur name change, actual location address:
| 1 |
Application form; |
| 2 |
Acting license original ; |
| 3 |
Information/documents indicating changes made ; |
| 4 | Payment order for the state fees payment of 750.00 roubles (link) |
The list of the documents on the license renewal in case of carrying out the activity on medical equipment production and maintenance at the address of the place of implementation, not indicated in the license.
| 1 |
Application |
| 2 |
Acting license original; |
| 3 |
Information on documents confirming ownership or other legal basis for the use of premises, buildings, structures at the place of implementation of the licensed type of activity, necessary for implementation of activities for the production and maintenance of medical equipment ; |
| 4 |
Registration certificate with the current production address |
| 5 |
Information about the availability of employees who meet the licensing requirements; |
| 6 |
Certificate of verification of measuring instruments. Information on the availability of auxiliary equipment, operational documentation for serviced medical equipment; |
| 7 |
Details of manufacturer’s operational documentation required for the maintenance of the declared groups of medical devices by classes of potential risk of use (if any); |
| 8 |
Details of documents confirming that the licensee has a quality management system that meets the requirements of the interstate standard GOST ISO 13485-2017; |
| 9 |
Payment order for the state fees payment of 3500.00 roubles. (link) |
The list of the documents for reissuing a license in case of the licensee’s intention to perform new work, provide new services that constitute the production and maintenance of medical equipment
| 1 | Application form |
| 2 | Acting license original; |
| 3 |
Information on documents confirming ownership or other legal basis for the use of premises, buildings, structures at the place of implementation of the licensed type of activity, necessary for implementation of activities for the production and maintenance of medical equipment; |
| 4 |
Registration certificate with the current production address |
| 5 |
Information about the availability of employees who meet the licensing requirements; |
| 6 |
Certificate of verification of measuring instruments. Information on the availability of auxiliary equipment, operational documentation for serviced medical equipment; |
| 7 |
Details of manufacturer’s operational documentation required for the maintenance of the declared groups of medical devices by classes of potential risk of use (if any); |
| 8 |
Details of documents confirming that the licensee has a quality management system that meets the requirements of the interstate standard GOST ISO 13485-2017; |
| 9 |
Payment order for the state fees payment of 3500.00 roubles. (link) |
The list of the documents for reissuing a license in case of termination of activities at one of the addresses:
| 1 |
Application form; |
| 2 |
Original valid license; |
| 3 | State duty payment order of 750.00 roubles (link). |
In case of medical equipment production containing sources of ionizing radiation (generating), besides Roszdravnadzor’s license for medical equipment production it is necessary to obtain Rospotrebnadzor’s license for designing and engineering, production of sources of ionizing radiation (generating).
Our company is ready to provide the whole scope of services to obtain an appropriate Rospotrebnadzor’s license document.
