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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of October 2, 2013 No. 755

About approval of the Technical regulation of rather active medical products which implant

(as amended on 27-03-2019)

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 active medical products which implant, and the actions plan on its use which are applied.

2. To provide to public service on medicines and control of drugs use of the Technical regulation approved by this resolution.

2-1. Determine that provision in the market and/or commissioning of active medical products which implant, undergone state registration are entered in the State register of medical equipment and products of medical prescription and are permitted 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.

Such active medical products which implant 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 in the market before the termination of term them to the validity, but.

2-2. 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" introduction into circulation of the active medical products which implant 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 19 are not fulfilled - 21 Technical regulation 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:

the resolution of the Cabinet of Ministers of Ukraine of July 9, 2008 No. 621 "About approval of the Technical regulation of rather active medical products which implant" (The Official Bulletin of Ukraine, 2008, No. 52, the Art. 1737);

Item of 6 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of October 4, 2010 No. 902 (The Official Bulletin of Ukraine, 2010, No. 75, the Art. 2668);

Item of 5 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of November 16, 2011 No. 1171 (The Official Bulletin of Ukraine, 2011, No. 89, the Art. 3236);

Item of 2 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of August 28, 2013 No. 632 (The Official Bulletin of Ukraine, 2013, No. 69, the Art. 2533).

4. This resolution becomes effective in six months from the date of publication.

Prime Minister of Ukraine     

N. Azarov

 

Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013, No. 755

The technical regulation of carrying out active medical products which implant

General part

1. Action of this Technical regulation extends to active medical products which implant.

This Technical regulation No. 90/385/EEC on rapprochement of the legislation of state members regarding active medical products which implant is developed on the basis of the Directive of the EU Council of June 20, 1990.

2. The terms used in this Technical regulation have the following value:

1) active medical product - any medical product which work depends on availability of source of the electric power or any other energy source, except directly generated human body or gravity (gravitation);

2) active medical product which is implanted (further - product), - the active medical product intended for complete or partial introduction in the patient's body in surgical or other medical way or through natural foramen which shall remain in body after the end of procedure of introduction;

3) commissioning - readiness of product for the first use to destination;

4) issuance - the first emergence of product in the market of Ukraine for the purpose of distribution and/or use to destination, except the products intended for clinical trials or assessment of characteristics;

5) the product made to order - any product which is specially made according to written doctor's instructions or person having appropriate level of professional qualification who determines specific constructional characteristics of this product intended only for the specific consumer;

6) the product intended for clinical trials - product, held for use the health worker having appropriate level of professional qualification during conduct of clinical trials in the corresponding clinical conditions;

7) the product intended for assessment of characteristics - the product intended by the manufacturer for carrying out over it one or more researches of product characteristics in the laboratories which are carrying out medical analyses or in other proper conditions outside its own rooms;

8) the producer - legal entity or physical person - the entrepreneur which is responsible for development, production, packaging and marking of product before its input in the address under own name irrespective of, the specified actions by such person personally are made or other person, the representative to be effective from his name.

Obligations of producers shall carry out also legal entities or physical persons - entrepreneurs who collect, pack, completely reconstruct

and/or mark one or more finished products and/or determine their appointment as products for the purpose of introduction of such products in the address under own name, except persons who collect the product which is already extended in the market or adapt it for needs of the specific consumer;

9) use to destination - use of product according to the purposes specified by the producer in marking and/or the application instruction;

10) the application instruction - information provided by the producer for the purpose of informing the user or the consumer on appointment and the correct use of product and precautionary measures which shall be accepted in case of use;

11) clinical data - data on safety and/or operational product characteristics which come to light during its proper use. Source of clinical data are:

clinical trials of the product corresponding to it;

clinical trials which results are published in scientific literature, the products concerning similar to it for which equivalence with this product can be confirmed;

reports on practice of use of this or similar product for which equivalence with this product can be confirmed;

12) clinical trials - any systematic research which is performed when using product to destination by one or several consumers which purpose is assessment of safety or operational product characteristics;

13) the plan of clinical trials - the document in which reasons, the purposes, the offered analysis, methodology, monitoring, carrying out and documentation of clinical trial are stated;

14) the authorized representative - any legal or physical person entrepreneur who is resident of Ukraine or registered according to the legislation of Ukraine and also the representative office of overseas enterprise having properly confirmed powers from the producer to make legal acts from his name concerning the obligations of the producer 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 product is intended for introduction in medicine human body, action of this Technical regulation extends to such product.

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