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).