Greetings from the designated conformity assessment body IMPROVE MEDICAL UA.TR.120.
The Information Services Center of IMPROVE MEDICAL specifically for you has summarized the main regulatory news in the market of medical devices since release of the previous digest 2020.
Please see below the third news digest in 2020 in the field of “medical devices”.
- On April 15, the amendments envisaged by Resolution of the Cabinet of Ministers of Ukraine of April 08, 2020, No. 271, came into effect.
The Ministry of Finance of Ukraine notes that pursuant to the provisions of the Law of Ukraine of March 30, 2020, No. 540-IX on providing additional guarantees in connection with the spread of coronavirus disease, the Government has improved the provisions of certain laws and regulation on the import into Ukraine and/or the introduction of certain anti-epidemic and medical devices the import and/or delivery transactions of which are exempt from taxation.
Resolution of the Cabinet of Ministers No. 271 amended 6 resolutions, according to which:
- the list of goods and equipment has been expanded both when imported into Ukraine and when manufactured in the territory of Ukraine, which are exempt from VAT;
- it is allowed to confirm compliance with the technical regulations of medical devices, equipment and personal protective equipment both according to standard and available documents (declaration of conformity), and by receiving confirmation letters from the Ministry of Health and the State Labor Service;
- some items on the list of anti-epidemic goods, which are not allowed to be exported by citizens, are supplemented by separate codes on the UCGFEA;
- criteria for classifying goods as anti-epidemic goods for the purpose of prohibiting the export by the citizens from Ukraine;
- unequivocal grounds have been identified for classifying medical devices and medical equipment as those exempted from import duties and VAT.
The above act amended the Technical Regulations for medical devices No. 753, 754 and 755 of October 02, 2013, establishing the mechanism for putting into circulation the products from the preferential List approved by the Government Resolution of March 20, 2020, No. 224, for which the requirements of the Technical regulations were not met.
It is permitted to put into circulation and/or operation the medical devices:
- if the goods comply with the requirements of technical regulations;
- on the basis of a notification to the Ministry of Health about putting into circulation for medical devices for which the requirements of technical regulations were not met, but the use of which is necessary in the interests of healthcare.
In its clarification of April 16, the Ministry of Health reports that a simplified procedure for introducing certain medical devices into circulation and tax benefits were introduced not only for the import of goods, but also for the circulation of medical devices in the domestic market of Ukraine.
The rule applies to imported products and Ukrainian producers.
In addition, the Government Resolution No. 271 cancelled the mandatory requirement to supply medical devices exclusively to healthcare facilities providing care to patients with COVID-19.
Further the Government Resolution No. 271 changed the procedure for submitting a package of documents to the Ministry of Health for putting into circulation and/or operation of such medical devices on the basis of a notification from the Ministry of Health. In addition, the applicant submits an application to the indicated authority (in any format) indicating the purpose of putting into circulation and/or operation, information about the manufacturer, product names, lot or serial number, lot size, product purpose and mode of action, also the statement should be added with
- a document of conformity issued outside Ukraine (if any)
- a letter of confirmation from the applicant stating that the conformity assessment of medical devices for which the applicant is submitting an application has not been carried out.
According to the Government Resolution No. 271, the technical regulations for medical devices No. 753, 754 and 755 of October 2, 2013 also stipulated the authority vested in the State Service of Ukraine regarding the exclusion (deletion) of information from the Register of persons responsible for introducing medical devices, active implantable medical devices and in vitro diagnostic medical devices into circulation approved by Order of the Ministry of Health of February 10, 2017, No. 122.
Such exclusion (deletion) from the Register will occur on the basis of an order of the State Service of Ukrainian Medicines and Drugs Control issued in accordance with the decision of the Service approved without the participation of the Ministry of Health.
The following circumstances shall be the grounds for such exclusion from the Register:
- termination of activities of the person responsible for the introduction of devices into circulation;
- non-compliance of devices with the established requirements;
- provision of false information by the person responsible for the introduction of devices 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, agreement, contract, etc.);
- written statement of the person responsible for putting the devices into circulation.
In addition to amendments to the technical regulations, the Government Resolution No. 271 introduces a number of corrective changes on taxation of products from the preferential list (Resolution of the Cabinet of Ministers of Ukraine of March 20, 2020, No. 224).
Thus, in addition to updating the name of the list, the list of devices itself was expanded. The medical devices exempted from VAT now also include computer tomographs, video bronchoscopes, diagnostic x-ray machines, portable electrocardiographs, defibrillators and ultrasound machines with a set of sensors.
Resolution No. 271 stipulates that in order to confirm the intended use of medical devices / personal protective equipment to combat COVID-19, there should be:
- a declaration of conformity has been submitted and applied to the product or its packaging, as well as to accompanying documents, if such documents are stipulated by the appropriate technical regulations, a mark of compliance with the technical regulations in accordance with the rules and conditions for its application specified in the technical regulations;
- a notice was submitted by the Ministry of Health about putting into circulation and/or operation of medical devices (medical devices for in vitro diagnostics, active implantable medical devices), for which the requirements of technical regulations are not met, or a communication from the State Labor Service about putting into circulation of personal protective equipment for which the requirements of technical regulations are not met.
- On April 19, the amendments envisaged by the Law of Ukraine “On Amending the Law of Ukraine “On Public Procurement” and some other legislative acts of Ukraine regarding the improvement of public procurement” became effective.
Details of the amendments are given in the publication of the Public Company “PROZORRO” at link.
The Ministry of Economy published earlier a public procurement report for 2019.
- To the attention of importers and domestic business entities that introduce personal protective equipment that prevents the spread of COVID-19
In accordance with the List of Product Types for which market surveillance authorities carry out state market surveillance, approved by the Cabinet of Ministers of Ukraine of December 26, 2016, No. 1069, the State Labor Service is designated as the state market surveillance authority with respect to personal protective equipment.
Resolution of the Cabinet of Ministers of Ukraine of March 20, 2020, No. 226 ratifies the amendments to the Technical Regulations of Personal Protective Equipment, approved by Resolution of the Cabinet of Ministers of Ukraine of August 27, 2008, No. 761.
According to the above amendments, for the duration of paragraphs 4 and 5 of Section I of the Law of Ukraine of March 17, 2020, No. 530-IX “On amending some laws and regulations of Ukraine aimed at preventing the emergence and spread of coronavirus disease (COVID-19)”, the technical regulation does not apply to personal protective equipment included in the preferential list approved by Resolution of the Cabinet of Ministers of Ukraine of March 20, 2020, No. 224.
To put in circulation personal protective equipment included in the specified list, the applicant submits an application to the State Labor Service specifying:
- import purposes,
- information about the manufacturer,
- product names, code according to UCGFEA,
- lot or serial number,
- lot size,
- data on the purpose of the product and method of action.
The application is submitted remotely by e-mail (or in another way) to the territorial authority of the State Labor Service at the place of state registration of the applicant.
The State Labor Service developed a standard application form, which can be downloaded at link.
According to the results of processing the submitted documents, the State Labor Service gives the applicant a notice on putting of individual protective equipment into circulation, for which the requirements of technical regulations are not met, but the use of which is necessary in the interests of healthcare.
- To the attention of market operators involved in the import and supply of disinfectants in the customs territory of Ukraine.
The Government approved Resolution of the Cabinet of Ministers of Ukraine of March 25, 2020, No. 232 “On Amending paragraph 4 of the Procedure for State Registration (Re-registration) of Disinfectants”, envisaging the possibility of registering disinfectants on the basis of positive findings of the state sanitary and epidemiological examination before the entry into force of new procedures for the study of specific activity, safety, quality (effectiveness) of disinfectants and their testing in practice.
To accelerate the process of registration (re-registration) of those disinfectants that received or will receive the conclusion of the state sanitary and epidemiological examination in accordance with paragraph 4 of the Procedure, registration (re-registration) of means will be carried out according to a simplified procedure.
To do this, the applicant shall submit a letter to the Ministry of Health of Ukraine regarding the registration (re-registration) of the disinfectant with the addition of a certified copy of the conclusion of the state sanitary and epidemiological examination to the letter.
After checking the submitted documents for compliance with the requirements established in the Procedure for state registration (re-registration) of disinfectants, the Ministry of Health of Ukraine within 30 days puts the disinfectant on the State Register of Disinfectants.
According to paragraph 3 of the Procedure for state registration (re-registration) means is considered to be registered from the moment it is entered in the State Register of Disinfectants, which is posted on the official website of the Ministry of Health of Ukraine in the “Open Data” section.
- The European Commission postpones application of MDR due to coronavirus for one year.
On April 3, the European Commission published on its website the accepted the proposal on the postponement of the mandatory application of MDR for one year (until May 26, 2021), so that member states, healthcare institutions and economic entities can give priority to combating the coronavirus pandemic.
This decision takes into account the unprecedented problems of the coronavirus pandemic and the need to increase the availability of vital medical devices throughout the EU, while continuing to ensure the health and safety of patients until new legislation comes into force.
This proposal will not affect the date of application of IVDR, which will enter into force on May 26, 2022.
- In April, IMPROVE MEDICAL held a webinar that focused on changes in the technical regulation of medical devices in a pandemic of COVID-19. The speaker discussed the following issues in the report:
- What regulations have been introduced to regulate the circulation of medical devices in connection with the COVID-19 pandemic? Their essence, scope and summary;
- How will the new regulations affect the import and supply of medical devices in the customs territory of Ukraine?
- How to ensure the proper functioning of an integrated system for monitoring the safety and effectiveness of medical devices put into circulation?
- Post-marketing surveillance of medical devices during and after the COVID-19 pandemic.
The video of the event is available at link.
- On May 14, IMPROVE MEDICAL will hold a free webinar “Risk analysis and management in accordance with the requirements of DSTU EN ISO 13485”.
The agenda will include, in particular, the following points:
- Risk analysis and management system: how to stop being afraid of it?
- Risk management plan.
- Risk assessment for each dangerous situation.
- Risk management report.
- What does effective risk management depend on?
- How to make risk management a mechanism for continuous improvement?
Registration is open here link.
For participation in our training events, please contact 044 355 50 30 or е-mail firstname.lastname@example.org
Best regards, sincerely yours, Svetlana Zgonnik and the team of improvemed.com.ua