Licence for manufacturing and assuring maintenance of medical products

When a licence is required

A licence is indispensable for various types of activities related to medical devices, such as manufacturing, servicing and repairing. A licence is issued to legal entities or entrepreneurs that do not make part of any legal entities.

Below you will find a list of the main types of medical devices that require a licence for their manufacturing, repairing and servicing:

  • appliances and equipment for traumatology and mechanotherapy;
  • hospital equipment;
  • comprehensive medical centres;
  • pharmaceutical equipment;
  • cosmetology equipment;
  • disinfection equipment;
  • medical furniture;
  • sterilisation equipment and desinfection equipment;
  • balneology and hydrotherapy equipment;
  • diagnostic and treatment equipment and appliances (excluding equipment and appliances for radioisotopic diagnostics);
  • devices, appliances and equipment for: ophthalmology, otolaryngology, dentistry, surgery and neurosurgery, radiology and tomography, urology and extracorporeal blood purification; physiotherapy, functional diagnostics; laser (therapeutic and surgical) intervention, when practised during laboratory and morphological analyses and by sanitary and epidemiological centres;
  • anaesthetic and respiratory equipment and intensive care equipment, machines and appliances;
  • ambulance car and mobile ICU equipment;
  • obstetrics, gynaecology and neonatology devices and equipment;
  • hear aids and endoscopic equipment.

Who issues the licence

The licences for manufacturing, servicing and repairing medical devices are issued by the Federal Service for the Oversight in Healthcare (Roszdravnadzor).