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Licensing of Medical Equipment Production

Sample of license for medical equipment production

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;
  • Scanners;
  • 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

Required Documents:

  • Registration and incorporation documents of the company (Charter, certificate of incorporation, the provision on the establishment of the organization and the appointment of the Director, the certificate on the state registration of the legal entity, the certificate on accounting in tax Department, the certificate on registration of changes in the event of a change of CEO or change in the constituent documents, company details, certificate of incorporation and codes of the state statistics Committee);
  • Documents confirming the qualification of employees and their experience in the field of production and maintenance of medical equipment (diploma, employment history, certificate of qualification, labor contract, letter of employment, a document on the change of surname in case of marriage);
  • Documents confirming the right of ownership of the organization on premises used for the production and maintenance of medical equipment (lease agreement or certificate of title, floor plan of the premises, acceptance certificate);
  • Documents for the equipment (the nomenclature and the list of manufactured medical equipment, copies of patents or licensing agreements that allow its production and sale, the documents confirming the registration of the manufactured equipment on the territory of Russia);
  • Documents confirming the availability of organizational-technical conditions and facilities for the production and maintenance of medical equipment (invoice, packing list, inspection certificate of inspection, equipment lease certificate).
  • State duty payment receipt;
  • Power of Attorney.

Procedure of Licensing

  1. Acceptance and primary analysis of the submitted documents and information;
  2. Documents check for compliance with legal requirements;
  3. Transmission of package of documents to the Federal Service of Supervision in Healthcare with documents inventory list and documents acceptance certificate;
  4. Documents inspection by the Federal Service of Supervision in Healthcare in the RF;
  5. 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.

Legal Norms

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.

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How to order this service?

To do that you are requested to leave an application.
Within 5 minutes our specialists shall call you to make a proposal (price).

Order service

You have questions?

Our specialists are ready to provide consultation. Call us the below phone numbers or order a call and out specialists shall get in contact with you within 5 minutes.

8 800 333-25-40
Free call over the territory of Russia