Registration of medical products is a state procedure, the purpose of which is to allow the release of high-quality and safe products to the Russian market.
Licenses for the production, maintenance and repair of medical equipment are issued by the Federal Service for Supervision of Health and Social Development (Roszdravnadzor), the requirements for all three licenses are identical.
The scope of medical services includes a variety of activities, but without modern medical equipment, such services can not be provided.
Since the law makes high demands on health standards, compliance with the procedure for obtaining a license to maintain and repair medical equipment is necessary.
The order of individual production and industrial production of goods that fall under this type of licensing is determined by Roszdravnadzor and the legislation of the Russian Federation. Before the release of a certain medical device, you must obtain the appropriate registration certificate of Roszdravnadzor and insert it into a special register.
After entering the market and using in an institution, medical equipment must be inspected by a specialist of appropriate qualification. This type of activity is licensed for the maintenance of medical equipment.
Any equipment needs to be repaired after a certain period of work. And the requirements for medical technology are hardly higher than even the requirements for the safety of industrial devices. If a device is found to be faulty, only the licensed organization can repair it. Any organization is obliged to assist in carrying out activities for industrial control of hazardous production facilities, otherwise the head is responsible up to the criminal one.
An indicative list of types of medical equipment subject to licensing - for production, repair and maintenance:
The license for the production and handling of medical equipment is a strictly regulated document. Maintenance and repair of medical devices must be done on time - not only to ensure the safety of patients' health, but also to maintain the reputation of the institution, and to comply with legal requirements. Without a contract for the maintenance of medical equipment, it is impossible to obtain a license for the provision of medical services.
Part 4 of Article 38 of the Federal Law No. 323-FZ of 21.11.2011 (as amended on 13.07.2015.) "On the fundamentals of protecting the health of citizens in the Russian Federation" establishes that treatment of medical devices registered in the order established by law The Government of the Russian Federation, the federal executive body authorized by it.
Examination of the quality, efficiency and safety of a medical device is carried out by an expert institution in stages (two stages are envisaged):
a) at the first stage, the examination of the application for registration and the documents specified in paragraph 10 of the Rules is carried out to determine the possibility (impossibility) of conducting clinical trials of the medical device;
b) in the II stage, the completeness and results of technical tests, toxicological studies, clinical trials, and tests for the approval of the type of measuring instruments (for medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved Ministry of Health of the Russian Federation).
There is a list of medical organizations conducting clinical trials of medical devices, which is also managed by Roszdravnadzor.
Refusal to register medical equipment is issued in the case when the risk of harm to the health of citizens and medical workers due to the use of a medical device exceeds the effectiveness of its use.
Westmedgrupp has licenses for the production and maintenance of medical equipment in the field of gas supply, cryogenic installations, structural elements of clean rooms, chemical and biological protection systems. Our engineers were trained directly on the Flow-meter S.p.A production sites. (Bergamo, Lombardy, Italy), Habitare S.p.A (Gattatico, Lombardy, Italy), HVM s.r.l. (Livorno, Tuscany, Italy), MILS (France).
Also, the employees of our company were trained in the program "Development, production, installation, adjustment, maintenance, repair, operation and quality control of medical equipment" in the FGBOU HPE "MSTU. N.E. Bauman. "
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