of October 2, 2013 No. 753
About approval of the Technical regulation of rather medical products
According to article 5 of the Law of Ukraine "About technical regulations and assessment of conformity the Cabinet of Ministers of Ukraine decides:
1. Approve the Technical regulation of rather medical products and the actions plan on its use which are attached.
2-1. Determine that in the market and/or commissioning of the medical products which underwent state registration which are entered in the State register of medical equipment and products of medical prescription and are resolved provision for use in the territory of Ukraine and were introduced into circulation before date of obligatory use of the technical regulation it is allowed without passing of assessment procedure of compliance and marking by national mark of conformity.
Also no more than five years from the date of issuance, without passing of assessment procedure of compliance and marking by national mark of conformity are allowed to provide such medical products in the market before the expiration of their period of validity.
2-2. Determine that till January 1, 2016 action of the Technical regulation approved by this resolution does not extend to technical and other means of rehabilitation of serial production from among medical products according to the list of technical and other means of rehabilitation for disabled people, handicapped children and other separate categories of the population approved by the resolution of the Cabinet of Ministers of Ukraine of April 5, 2012 No. 321 (The Official Bulletin of Ukraine, 2012, No. 31, of the Art. 1146).
2-3. Determine what for the period of operation of the Law of Ukraine "About introduction of amendments to some laws of Ukraine concerning ensuring timely access for patients to necessary medicines and medical products by implementation of public procurements with involvement of the specialized organizations conducting procurement" issuance of the medical products which are subject to purchase according to the purchase agreements signed by the Ministry of Health with the specialized organizations which conduct procurements concerning which requirements of Items 15 - 19 Technical regulations are not fulfilled approved by this resolution is allowed on condition of recognition by the appointed conformity assessment body of results of the assessment of conformity which is carried out by foreign accredited bodies on assessment of conformity according to requirements of part three of article 45 of the Law of Ukraine "About technical regulations and assessment of conformity".
3. Recognize invalid resolutions of the Cabinet of Ministers of Ukraine according to the list which is attached.
4. This resolution becomes effective in six months from the date of publication, except Items 1, 3-6, 8, of the 9 and 11 list of resolutions of the Cabinet of Ministers of Ukraine, invalid, approved by this resolution which become effective since July 1, 2015.
Prime Minister of Ukraine
Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013, No. 753
1. Action of this Technical regulation extends to medical products and supportive applications to them (further - medical products). For the purposes of this Technical regulation supportive applications are considered as medical products.
This Technical regulation No. 93/42/EEC on medical products is developed on the basis of the Directive of the EU Council of June 14, 1993.
2. The terms used in this Technical regulation have the following value:
1) putting into operation - readiness of medical product before the first use to destination the end user and/or the consumer;
2) issuance - the first emergence of medical product, except the medical products intended for clinical trials or assessment of characteristics in the market of Ukraine for the purpose of distribution and/or use to destination irrespective of whether this medical product is new or completely recovered;
3) the medical product made to order - any medical the product, specially made according to written doctor's instructions or person having appropriate level of professional qualification determines specific constructional characteristics of this medical product intended only for the specific consumer.
The medical product of serial production which change of characteristics is performed for satisfaction of individual needs of person practising medicine or any other professional user is not the medical product made to order;
4) the producer - the legal entity or the physical person - the entrepreneur, is responsible for development, production, packaging and marking of medical product before its input in the address under own name irrespective of, the specified actions by such person or the other person, representative are made to be effective from her name.
Obligations of producers are also carried out by legal entities or physical persons - entrepreneurs who collect, pack, completely reconstruct and/or mark one or more finished medical goods and/or determine their appointment as medical products for the purpose of introduction of such products in the address under own name, except persons who collect medical product already extends in the market, or adapt it for needs of the specific consumer;
5) supportive application - the product which is not medical product, but is intended by the producer especially for use with medical product for proper use of such product to destination;
6) general group of medical products - the group of the medical products having identical or similar scopes of application or are characterized by similarity of technologies;
8) clinical data - data on safety and/or operational characteristics of medical product which come to light during its proper use. Source of clinical data are:
clinical research / clinical trials of the corresponding product;
clinical research / clinical trials or other researches concerning similar product for which equivalence with product and which results are published in scientific literature can be confirmed;
the published and/or unpublished reports on other clinical experiences concerning this or similar product for which equivalence with product can be confirmed;
9) medical product - any tool, the device, the device, the device, the software, material or other product applied as separately and in combination among themselves (including the software provided by the producer for use especially for the diagnostic and/or therapeutic purposes and which is necessary for proper functioning of medical product), the expected action of which intended by the producer for use for the purpose of ensuring diagnosis, prevention, monitoring, treatment or simplification of disease of the patient in case, diagnoses, monitoring, treatment, simplification of condition of the patient in case of injury or disability or their compensation, research, replacement, modification or maintenance of anatomy or physiological process, control of process of fertilization and the main in organism or on human body it is not reached by means of pharmacological, immunological or metabolic means, but to functioning of which such means can promote;
10) the medical product intended for clinical trials - medical product (except medical products for diagnosis of in vitro), held for use the health worker having the corresponding qualification during conduct of clinical trials;
11) medical product disposable - the medical product intended for use only once only for one patient;
12) subcategory of medical products - the group of the medical products having identical scope of application to destination or are characterized general technology;
13) the authorized representative - any legal entity or the physical person - the entrepreneur who is resident of Ukraine or registered according to the legislation of Ukraine, representative office of overseas enterprise, having properly confirmed powers from the producer to make the legal acts from his name in the line of duty for bonds with producers established by this Technical regulation.
For the purposes of this Technical regulation the term "national standards" is used in the value given in the Law of Ukraine "About standardization", terms "conformity assessment body", "risk", "technical regulation" - in the value given in the Law of Ukraine "About technical regulations and assessment of conformity", the term "medicines" - in the value given in the Law of Ukraine "About medicines".
3. If the medical product is intended for introduction in medicine human body, action of this Technical regulation extends to such product.
If the specified meditsinsy product is introduced into circulation in such a way that the medical product and medicine form single complete product and medical product is intended only for use in the corresponding combination and not intended for reuse, such product is subject to regulation of the Law of Ukraine "About medicines". Requirements to the medical products given in appendix 1, extend only to the characteristics of medical product testimonial of its safety and efficiency.
4. If medical products contain as integral part substance which in case of its separate use can be considered as medicine and which effect on organism is auxiliary concerning action of medical product, such medical products are subject to assessment of conformity and issuance according to this Technical regulation.
If medical products contain as integral part substance which in case of separate use can be considered as component of medicine or as the medicine received from blood or blood plasma of the person and which impact on organism is auxiliary concerning action of medical product such medical products are subject to assessment of conformity and issuance as medical products according to this Technical regulation.
5. Action of this Technical regulation does not extend on:
1) medical products for diagnosis of in vitro;
2) active medical products which implant;
3) medicines on which operation of the Law of Ukraine "On medicines" expatiates. The main criterion in case of reference of product to medicines or to medical products is the basic principle of action of product;
5) blood of the person, drugs which receive from blood of the person, plasma or blood cells of the person, and also product which at the time of issuance contain such blood preparations, plasma or cells, except the products specified in the paragraph the second item 4 of this Technical regulation;
6) anatomic materials of human origin, and also the medical products containing anatomic materials of human origin or made of them, except the products specified in the paragraph the second item 4 of this Technical regulation;
7) anatomic materials of animal origin, except cases when the medical product is made with use of impractical tissues of the animals or products made of impractical tissues of animals.
6. If the producer determines medical product as individual protection equipment, such medical product shall meet also established requirements for labor protection and safe engineering established in the Technical regulation of individual protection equipment approved by the resolution of the Cabinet of Ministers of Ukraine of August 27, 2008 No. 761 (The Official Bulletin of Ukraine, 2008, No. 66, the Art. 2216).
7. Action of the Technical regulation on electromagnetic compatibility of the equipment approved by the resolution of the Cabinet of Ministers of Ukraine of July 29, 2009 No. 785 (The Official Bulletin of Ukraine, 2009, No. 58, the page 2028), does not extend to products to which action of this Technical regulation extends.
8. This Technical regulation does not exclude use of the Technical regulation of the closed sources of the ionizing radiation approved by the resolution of the Cabinet of Ministers of Ukraine of December 5, 2007 No. 1382 (The Official Bulletin of Ukraine, 2007, No. 93, the Art. 3408).
9. Issuance and/or operation of medical products it is allowed only if they completely conform to requirements of this Technical regulation, on condition of proper supply, installation, maintenance and their use to destination.
The medical products meeting the requirements of the national standards included in the list of the national standards conforming to the European harmonized standards and which voluntary use can be perceived as the proof of compliance of medical products to requirements of this Technical regulation are considered conforming to requirements of this Technical regulation.
The list of the national standards conforming to the European harmonized standards and which voluntary use can be perceived as the proof of compliance of medical products to requirements of this Technical regulation joins monographs (pharmacopoeian Articles) of the State pharmacopeia of Ukraine, in particular rather surgical suture material and interaction between medicines and materials, are applied in the products containing such medicines.
10. The equipment provided at the venue of fair, exhibition, display or is shown in a different way and does not meet the requirements of this Technical regulation, shall be followed by visible mark which shows that such equipment cannot be introduced into circulation or to operation without its reduction in compliance to requirements of this Technical regulation. Demonstration of operation of such equipment is possible only on condition of acceptance of proper measures for prevention of electromagnetic hindrances.
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