The Resolution of the Cabinet of Ministers of Ukraine of March 20, 2020 No. 226 became effective on Saturday, March 21.
The full text of the Resolution is available at the following link.
Main provisions of amendments:
For the duration of items 4 and 5 of section I of the Law of Ukraine of March 17, 2020 No. 530-IX “On Amendments to Certain Legislative Acts Aimed at Prevention of the Occurrence and Spread of Coronavirus Disease (COVID-19)” the effect of medical Technical regulations shall not apply to medical devices included in the list of pharmaceutical products, medical devices and/or medical equipment necessary for the implementation of measures aimed at prevention of the occurrence and spread, localization and elimination of outbreaks, epidemics and pandemics of coronavirus disease (COVID-19) that are exempt from import duties and importation of which into the customs territory of Ukraine is exempt from VAT taxation (hereinafter referred to as the List).
The applicant submits an application to the Ministry of Health for putting into circulation and/or operation of medical devices included in the referred List.
The application must include the following information:
- Import purpose,
- information about the manufacturer,
- names of medical devices,
- batch number or serial number,
- batch quantity,
- intended use of the device and its mode of operation.
After considering the results of the handling of submitted documents, the Ministry of Health issues to the applicant a notice about putting into circulation and operation of the medical devices that don’t meet the requirements of the technical regulations, but the use of which is necessary for health care.
Documents’ review and issuance of the notice are free of charge.
The Resolution doesn’t set the timeframe for document review and issuance of the notice, as well as the grounds for leaving the application undecided/refusal of the application.
The Ministry of Health of Ukraine emphasizes that notices about putting into circulation and operation will be issued exclusively for certain medical devices that don’t meet the requirements of the technical regulations, but the use of which is necessary for health care.
In order to speed up the receipt of notice about putting into circulation and operation of certain medical devices that don’t meet the requirements of the technical regulations, but the use of which is necessary for health care from the Ministry of Health of Ukraine, if available it is necessary to attach to the application certificates/declarations of conformity, obtained according to the procedure specified in technical regulations, approved by the CMU Resolutions No. 753, No. 754, No. 755 of October 2, 2013, or a letter confirming that the products didn’t pass the conformity assessment.
The Ministry of Health notes that the fitting criterion for the medical devices that are supplied specifically to health care institutions providing medical treatment to patients with COVID-19 can be:
- contract (agreement) for the supply of goods concluded between the applicant and the buyer,
- confirmation letter from the Department of Health or the Health Authority of State Administrations,
- confirmation letter from the health care institution,
- etc.
The document also amended the Resolution of the Cabinet of Ministers of Ukraine of August 27, 2008 No. 761 “On Approval of the Technical Regulation of Personal Protective Equipment”.
Similar to medical devices, in order to put the personal protective equipment into circulation, included in the referred List, the applicant must submit to the State Labor Service an application indicating the purpose of import, information about the manufacturer, names of medical devices, batch number or serial number, batch quantity, as well as information about the purpose of the device and its mode of operation.
After considering the results of the handling of submitted documents, the State Labor Service issues to the applicant a notice about putting into circulation of certain personal protective equipment that doesn’t meet the requirements of the technical regulations, but the use of which is necessary for health care.
Document review and issuance of the notice are free of charge.