In accordance with the valid legislation all medical equipment production and maintenance on the territory of the Russian Federation is subject to licensing. The producers of medical equipment shall have a license for medical equipment production and maintenance.
The license is issued by Federal Service for Healthcare (Roszdravnadzor) foe individual or serial production of medical equipment. Licensing is not required only in cases when the maintenance is carried out privately, for the own needs of the considered legal entity or individual entrepreneur.
The license has no validity limit.
The state duty for the registration of the license is 7 500 rubles.
Medical Equipment subject to licensing
- Equipment for x-ray studies;
- Dental instruments and devices;
- Surgical and neurosurgical instruments;
- Endoscopic equipment;
- Physiotherapeutic devices;
- Equipment for functional diagnostics;
- Laser medical devices;
- Equipment for sterilization of medical instruments and equipment;
- Equipment used in obstetrics, gynecology and neonatology;
- Hearing aid and equipment for otolaryngology;
- Equipment for the urology and blood purification;
- Ophthalmologic equipment;
- Equipment for traumatology and mechanotherapy;
- Equipment for laboratory tests subject to licensing.
Services subject to licensing:
- Installation and tuning of medical equipment;
- Control over the technical condition of medical equipment;
- Current and periodical maintenance and repair of medical equipment.
Licensing of medical equipment production and maintenance
Procedure of Licensing
- Acceptance and primary analysis of the submitted documents and information;
- Documents check for compliance with legal requirements;
- Transmission of package of documents to the Federal Service of Supervision in Healthcare with documents inventory list and documents acceptance certificate;
- Documents inspection by the Federal Service of Supervision in Healthcare in the RF;
- Issue of license for production and maintenance of medical equipment.
The process of license preparation takes about 45 days depending on the terms of submission of the documents.
Attek group is ready to provide you with service on licensing of production and maintenance of medical equipment. Our specialists will safe your time required for preparation and submission of all required documents, provide assistance on all stages of approval. To make an order fill in the online application form.