Licensing of technical maintenance and manufacturing of medical equipment
General information regarding licensing of technical maintenance of medical equipment.
Legal entities and individual entrepreneurs must have a license in order to conduct maintenance and repairing jobs of medical equipment (except those cases when these jobs are conducted to meet the own needs of the legal entities or individual entrepreneurs).
- This license is issued by the Federal Supervisory Service in healthcare and social development;
- This licence is valid for 5 years;
- Purpose of licensing:
- It is the main legal document for conducting activity of maintenance and repairing of medical equipment, when this equipment is used for its general purpose;
- This license defines the list of medical equipment for technical servicing and maintenance.
We provide a wide range of services in order to assist you to obtain medical activity license on the territory of RF:
- Preparation and filing of license package to Roszdravnadzor (Russian Federation Healthcare Authority);
- Referring and enrolling your specialists to the training and qualifications upgrade courses;
- Rent of control-measurement and testing equipment for the purpose of licensing.
Our consultants are ready to answer your individual questions regarding licensing of the activity involving the use of ionizing radiation sources. Do not hesitate to contact us in case you need more information.
General information regarding licensing of medical equipment manufacturing
In order to conduct activity of medical equipment manufacturing, including industrial manufacturing and individual production of medical equipment, legal entities and individual entrepreneurs must obtain a licence for medical equipment manufacturing.
- This licence is issued by the Federal Supervisory Service in healthcare and social development;
- This licence is valid for 5 years;
- Purpose of licensing:
- It is the main legal document for conducting activity of medical equipment manufacturing, including industrial production and individual manufacturing of medical equipment, which is carried out by legal entities and individual entrepreneur
- It defines the list of medical equipment for production on the territory of RF;
Our services of assisting in obtaining medical equipment production licence on the territory of RF are as follows:
- Preparation and filing of license package to Roszdravnadzor (Russian Federation Healthcare Authority);
- Referring and enrolling your specialists to the training and qualifications upgrade courses;
- Rent of control-measurement and testing equipment for the purpose of licensing.
Our consultants are ready to answer your individual questions regarding licensing of the activity involving the use of ionizing radiation sources. Do not hesitate to contact us in case you need more information.