The Government of Ukraine adopted the Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” of April 8, 2020 № 271, which entered into force on April 15, 2020 due to publication in the Government Courier (hereinafter – Resolution № 271).
Resolution № 271, in particular, amended the Medical Technical Regulations № 753-755 of 02.10.2013 and the Technical Regulations of Personal Protective Equipment, approved by the Resolution of the Cabinet of Ministers of Ukraine of 27 August 2008 № 761.
Thus, the new version sets out the norm of resolutions on approval of the above regulations, which establish the mechanism of putting into circulation products from the List № 224, in respect of which the requirements of the Technical Regulations are not met, for the period of paragraph 71 of subsection 2 of section XX “Transitional Provisions” Ukraine and paragraph 96 of Section XXI “Final and Transitional Provisions” of the Customs Code of Ukraine.
Such an introduction is allowed
- if the goods meet the requirements of the Technical Regulation;
- on the basis of a notification from the Ministry of Health of Ukraine for medical devices and the State Labor Service on the introduction of certain personal protective equipment in respect of which the requirements of technical regulations are not met, but the use of which is necessary in the interests of health.
In this case, the effect of these Technical Regulations does not apply to medical devices / personal protective equipment, which have been issued such a notification by the Ministry of Health of Ukraine / State Labor Service.
For putting into circulation and / or operation on the basis of the notification of the Ministry of Health of such medical devices the applicant submits to the specified body an application indicating the purpose of putting into circulation and / or operation, information on the manufacturer, product name, batch number or serial number, volume batch, purpose of the product and mode of action.
The application is also accompanied by:
- document of conformity issued outside Ukraine (if any);
- letter of confirmation of the applicant that the conformity assessment of medical devices has not been carried out.
In addition to making these changes, Resolution № 271 is designed to correct existing legal conflicts (legislative misunderstandings) and double interpretations of the legislation on VAT on medical devices.
Thus, Resolution № 271 also changes the name of the List № 224, and a number of its provisions are brought in line with COVID laws.
The List № 224 itself has been updated and expanded, in particular, computer tomographs, videoobronchoscope, portable X-ray diagnostic electrocardiograph, defibrillator and ultrasound device with a set of sensors are now included in the VAT-exempt medical devices.
To confirm the intended purpose of medical devices / personal protective equipment for the fight against COVID-19 in accordance with Resolution № 271 must be:
- a declaration of conformity is submitted and affixed to the product or its packaging, as well as to the accompanying documents, if such documents are provided by the relevant technical regulations, the mark of compliance with technical regulations in accordance with the rules and conditions of its application; or
- a notification of the Ministry of Health on the introduction into circulation and / or operation of medical devices (medical devices for in vitro diagnostics, active implantable medical devices) in respect of which the requirements of technical regulations are not met, or a notification of the State Labor Service introduction into circulation of personal protective equipment for which the requirements of technical regulations are not met.
However, in addition to the above changes, the Government has supplemented paragraph 31 of the Technical Regulation on Medical Devices, paragraph 23 of the Technical Regulation on Medical Devices for In Vitro Diagnostics, paragraph 35 of the Technical Regulation on Active Implantable Medical Devices, which gives unprecedented powers to information from the Register on the basis of an order issued in accordance with the decision.
The grounds for exclusion of information from the Register are:
- termination of the activity of the person responsible for putting products into circulation;
- non-compliance of products with the established requirements;
- providing inaccurate information to the person responsible for putting products into circulation;
- expiration of the declaration of conformity and / or certificate of conformity;
- termination or expiration of the power of attorney from the manufacturer to the authorized representative (power of attorney, contract, contract, etc.);
- a written statement of the person responsible for putting the products into circulation.
The official website of the Ministry of Health of Ukraine states that for medical devices put into circulation and / or operation on the basis of a notification from the Ministry of Health of Ukraine, it is not necessary to draw up a declaration of conformity, mark technical regulations, as well as for certain medical devices. it is not necessary to submit information to the Register of persons responsible for the introduction of medical devices into circulation.
The Ministry of Health of Ukraine notes that the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” applies to products for which the requirements of technical regulations are not met, but the use of which is necessary for the interests of health care.
The full version of the press release of the Ministry of Health of Ukraine is available at the following link https://moz.gov.ua/article/health/onovlena-informacija-schodo-timchasovih-zmin-pravil-vvezennja-medichnih-virobiv.