of November 9, 2004 No. 1497
About approval of the Procedure for state registration of medical equipment and products of medical appointment
According to the Presidential decree of Ukraine of February 7, 2003 N 91 "About measures for improvement of providing the population with medicines and products of medical appointment, and also increase in efficiency of public administration in this sphere" the Cabinet of Ministers of Ukraine decides:
Approve the Procedure for state registration of medical equipment and products of medical appointment it (is applied).
Prime Minister of Ukraine
Approved by the Resolution of the Cabinet of Ministers of Ukraine of November 9, 2004, No. 1497
1. This Procedure determines mechanisms of carrying out state registration of medical equipment and products of medical appointment (further - medical products).
The medical products made in Ukraine and imported according to the list which is determined by MZ are subject to state registration.
Import to customs area, realization and application in Ukraine of medical products is allowed only after their state registration, except the cases determined by MZ in accordance with the established procedure.
2. Terms which are used in this Procedure have the following value:
medical products - devices, complexes, systems, the equipment, devices, tools, devices, implants, accessories, materials or other products, including invasive medical products; medical products for diagnostics of in vitro; medical products which do not achieve the main provided objective in human body or on it by means of pharmacological, immunobiological or metabolic means, but to functions of which such products can promote; medical products which are used as separately, and in connection among themselves, including the software necessary for their proper use, for the purpose of providing:
- prevention, diagnostics, treatment, observation or simplification of condition of the patient in case, injuries, mutilations or their compensations;
- researches, replacements or modifications of structure (anatomy) of bodies, fabrics or physiological processes;
- fertilization process control;
delivery products - the products and devices intended as components for direct application in complex with certain medical products according to their functional purpose;
modifications of medical products - kinds of medical products which have the general constructive signs developed based on the main product for the purpose of expansion and/or specialization of the sphere of its use;
regulating documents - standards, specifications, directives, installations, other normative and technical documents on products, and also regulations, rules, norms which are determined by criteria of quality and safety of medical products and condition of their production and application;
registration materials - materials of preclinical studying, clinical testing, regulating documents on specific medical items and other specifications and technical documentation;
harm - deterioration in the state of health of the patient, personnel, damage or deterioration in functioning of the equipment or rendering negative environmental impact;
safety of medical products - set of the normalized properties of medical products which provide prevention of harm from their application;
danger - potential source of harm;
risk of application of medical products - the probable frequency of emergence of danger or probable strengthening of severity of condition from caused to the person or the environment of harm;
the applicant - legal entity or physical person which gives in accordance with the established procedure set of documents for state registration of medical products;
expert organization - the legal entity involved by Gosleksluzhboy for conducting examination (testing) of medical products;
examination of medical products - establishment of compliance of characteristics of medical products, their indicators, the registration materials including declared by the applicant, to regulating documents and the legislation concerning functioning, quality and safety for health of the person, the circle of its activity;
testing - determination of criteria, indicators by carrying out researches;
classification of medical products - reference or confirmation of belonging of product to one of safety classes depending on degree of potential risk of application;
advisory body - scientific advisory council concerning state registration of medical products which is created by Gosleksluzhboy for joint decision of questions in the sphere of turnover of medical products;
qualification test - monitoring test of samples of medical products for evaluating readiness of production to issue such products and determinations of their compliance to requirements of regulating documents.
3. State registration of medical products is performed by Gosleksluzhba by results of expertize and in case of need testing which are carried out by expert organizations.
4. State registration of medical products is carried out based on the statement and the corresponding document package provided to Gosleksluzhbu by the applicant who bears responsibility for production, safety, quality and efficiency of medical products.
Such data are noted in the statement:
the name of medical products (in Ukrainian and in English languages), number according to the catalog;
name of the applicant (country of incorporation of the applicant, address, phone, telefax, e-mail address). If the applicant is not producer, together with the statement the document which confirms its powers on state registration on behalf of the producer, with indication of name of a consignee of the certificate on state registration and its owner is filed;
name of the producer (country of incorporation of the producer, address, phone, telefax, e-mail address);
class of safety of medical products depending on degree of potential risk of application;
the paragraph of the seventh is excluded according to the Resolution of the Cabinet of Ministers of Ukraine of 20.06.2012 No. 548
5. Are enclosed to the application:
1) installation (instruction) for operation (application) of medical products;
2) certificate of origin of medical products;
3) the certificate of conformity of medical products to quality requirements and safety for health of the person;
4) copies of regulating documents, information concerning standards, the regulatory base based on which medical products are produced;
5) materials concerning determination of class of safety of medical products depending on degree of potential risk of application, and also materials of their preclinical and clinical studying and/or testing;
6) catalog of medical products;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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The document ceased to be valid since July 1, 2015 according to the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753