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

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" issuance and/or operation 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 parts one and third article 45 of the Law of Ukraine "About technical regulations and assessment of conformity".

2-3. Determine that for the period of action of Item 71 of subsection 2 of the Section XX "Transitional provisions" of the Tax code of Ukraine and Item 9-6 of the Section XXI "Final and transitional provisions" of the Customs code of Ukraine, issuance and/or operation of active medical products which implant, included in the inventory (including medicines, medical products and/or the medical equipment), the actions, necessary for accomplishment, directed to prevention of origin and distribution, localization and liquidation of flashes, epidemics and pandemics of acute respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus which are exempted from payment of import duty and which transactions on import to customs area of Ukraine and/or transaction on delivery of which on customs area of Ukraine are exempted from the taxation by the value added tax, No. 224 approved by the resolution of the Cabinet of Ministers of Ukraine of March 20, 2020 (The Official Bulletin of Ukraine, 2020, No. 26, the Art. 971), is allowed:

if they do not meet the requirements of the Technical regulation approved by this resolution; or

based on the notification of the Ministry of Health on issuance and/or operation of separate active medical products which implant, concerning which requirements of technical regulations are not fulfilled, but use of which it is necessary for the benefit of health protection.

At the same time action of the Technical regulation approved by this resolution does not extend to active medical products which implant, on which such notification of the Ministry of Health is issued.

For issuance and/or operation based on the notification of the Ministry of Health of such medical products the applicant submits in the specified body the application with indication of the purpose of issuance and/or operation, information on the producer, names of products, batch number or serial number, amount of batch, purpose of product and method of action. Also are enclosed to the application:

the document on compliance issued outside Ukraine (in case of availability);

the comfort letter of the applicant that assessment of conformity of medical products is not carried out.

By results of processing of the submitted documents Ministry of Health issues to the applicant the adequate notice. Consideration of documents and issue of the notification are performed on free basis.

2-4. Determine what issuance and/or operation of active medical products which implant which are bought by person authorized on implementation of purchases in the field of health care according to the list determined by the Cabinet of Ministers of Ukraine 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 parts one and third article 45 of the Law of Ukraine "About technical regulations and assessment of conformity".

2-5. Ceased to be valid according to the Resolution of the Cabinet of Ministers of Ukraine of 25.11.2022 No. 1317

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.

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;

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