We provide a rundown of the most critical regulatory news regarding medical devices in Ukraine.
From February 24 Ukraine defends from the armed aggression of the Russian Federation; the country is under martial law. Every day the aggressor strikes civilian infrastructure with rockets. On July 4, 2022, the Office of the UN High Commissioner for Human Rights reported 4,889 dead and 6,263 wounded civilians in Ukraine. It is noted that the real numbers are much higher, as each case is confirmed, and obtaining information is significantly complicated. As of the beginning of July, 817 healthcare institutions were damaged, of which 122 were completely destroyed.
Cratia fully restored operations in the middle of March, and as of today, we perform all types of regulatory activities.
We are grateful to the international community for its support, thanks to which we can defend ourselves and believe in a brighter future. We are grateful to our partners who provide the humanitarian aid that is so important for today's healthcare system. We are grateful to everyone in the world who has empathy and helps Ukrainians. We are endlessly grateful to the Armed Forces of Ukraine and the Civil Defense, doctors and medical workers, infrastructure workers, volunteers and many others.
Rehabilitation and assistive products
From July 1, 2022, changes that excluded provisions of Part 8 of Article 26 of the Law of Ukraine "On the Rehabilitation of Persons with Disabilities in Ukraine" (hereinafter the Law) entered into force. Changes cancel the requirements for the qualification conditions established by the Ministry of Social Policy for enterprises that implement the state program for free supply of rehabilitation products upon individual application of a person with a disability. At the same time, the Law establishes that the Technical regulation on medical devices regulates rehabilitation and assistive products.
Under the amendments of April 12, 2022 to Resolution No. 321, rehabilitation products intended for the free supply to persons with disabilities, children with disabilities, and other persons at the expense of the state budget are manufactured and supplied by enterprises that must be included in the Register of persons responsible for placing of medical devices on the market.
Thus, manufacturers of prosthetic and orthopedic products must perform the conformity assessment of rehabilitation products with the requirements of the Technical regulations for medical devices, approved by Resolution of the CMU No. 753 of October 2, 2013.
We remind you that class I medical devices should follow the conformity assessment according to Annex 8, and custom-made medical devices follow the procedure defined in Annex 9 to the Technical Regulations. Medical devices must comply with the requirements in Annex 1, that means the presence of appropriate documentation (technical file) that contains evidence for each applicable provision. The manufacturer must keep the relevant documentation accessible for the state market surveillance authority for at least five years (15 years for implantable products).
Unregistered medical devices and labeling in the state language
We remind you that by Letter No. 24-04/5396/2-22 dated February 25, 2022, the Ministry of Health of Ukraine allowed import and placing on the market medical devices without meeting the requirements of the relevant Technical Regulations. This letter also allows the labeling of medical devices without complying with the requirements of the Law of Ukraine "On Ensuring the Functioning of the Ukrainian Language as a State Language". Please note that the regular VAT rate of 20% is applied to such medical devices during customs clearance and circulation (instead of 7% VAT for devices that comply with the requirements of technical regulations) and there may be other restrictions during sale and participation in public procurement procedures.
By Letter No. 15.1.4-10/6024 dated June 2, 2022, the State Service of Ukraine for Food Safety and Consumer Protection informs that exceptions to labeling were applied to avoid a critical situation and shortage at the beginning of martial law, but in connection with gradual adaptation to new conditions, the competent authority informs on the need for strict compliance with the requirements of consumer rights legislation.
EC certificate recognition procedure
The changes of March 29 introduced simplifications to the conformity assessment of medical devices through the recognition of EC certificates. The recognition procedure allows the Ukrainian conformity assessment body to recognize the results of the European notified body (MDD or MDR, IVDD or IVDR) replacing certification and annual surveillance audits with assessment of the protocols.
We remind you that Article 45 of the Law of Ukraine "On Technical Regulations and Conformity Assessment" allowed recognition and acceptance of the results of conformity assessment performed in the EU under the Agreements on recognition with EU notified bodies. As of the beginning of July, Ukrainian conformity assessment bodies have Agreements on recognition with more than 30 notified bodies from the EU.
Cancellation of the list of critical imports
On July 7, the Cabinet of Ministers of Ukraine adopted amendments to Resolution No. 153 of February 24, 2022, which cancel the list of critical import goods. This means the ability to make payments in foreign currency to non-residents for any products.
Ban on Russian and Belarusian medical devices
Resolution of the CMU dated April 9, 2022 No. 426 prohibits the import of goods from the Russian Federation into the territory of Ukraine. Also, on the basis of letters from the Ministry of Economy of Ukraine and the National Accreditation Agency of Ukraine, conformity assessment bodies cancel certificates for products of operators registered in the Russian Federation and the Republic of Belarus.
Moratorium on state market surveillance and product control
By Resolution of the CMU No. 303 of March 13, 2022, planned and unplanned measures of state control and state market surveillance have been temporarily suspended. In addition, the Resolution of the CMU dated May 3, 2022 No. 550 suspended state control of non-food products by customs authorities. The moratorium is valid until the end of martial law in Ukraine.
Computer program interface and websites
From July 16 of this year, parts 2 and 6 of Article 27 of the Law of Ukraine "On Ensuring the Functioning of the Ukrainian Language as a State Language" come into force.
According to the Law, a computer program with a user interface installed on devices must have a user interface in national language equivalent to the foreign language version (some exemptions apply). Websites, web pages in social networks of bodies and business entities provided for in Part 6 of the Law must also be provided in Ukrainian language.
Electronic instructions for medical devices
Continuing the topic of digital technologies and digital transformation, Cratia has developed a solution that allows you to switch from paper to electronic instructions. The consumer (user) receives instant access to the current version of the electronic instruction for use (manual) via the QR code or the website https://e-ifu.com.ua and can order free delivery of the paper document.
That service will facilitate your business and increase the safety of medical devices due to:
- reducing costs and increasing competitiveness;
- simplifying user access to the current version of the manual and improving the overall safety of the product;
- reducing the time for bringing products on the market;
- simplifying the labeling process, improving compliance with regulatory requirements, simplifying inspections of state market surveillance bodies;
- reducing the environmental burden.
The decision was developed in accordance with the legislation of Ukraine, considering the requirements of GHTF/SG1/N70:2011, agreed with the position of the Ministry of Health of Ukraine and the market surveillance body regarding electronic instructions.
For medical devices supplied to Ukraine as humanitarian aid, we provide the service free of charge, except for the costs of printing and postal delivery.
Ukraine is a candidate state for EU membership
On June 23, Ukraine acquired the status of a candidate state for joining the European Union. The status of the candidate legally determines the movement of Ukraine towards full membership in the EU. This movement envisages the further approximation of the legislative system, infrastructure, principles and practices of Ukraine to the European Union.
Forum of medical device market operators
We invite you to participate in the 11th Ukrainian Forum of Medical Devices Market Operators, which will be held on August 26 at Premier Hotel Rus, Kyiv.
The Ukrainian Forum of Medical Products Market Operators provides manufacturers, suppliers, distributors, and importers of medical products with a platform for solving all urgent issues, discussions, recommendations, and sharing valuable business experience during martial law.
Cratia will speak on electronic instructions for medical devices in Ukraine and conformity assessment of nationally manufactured medical devices to the requirements of the European Union (EU Regulation 2017/745).
Registration on the Forum’s website: https://ukrcomexpo.com/medical-devices-2022/
Have any questions or want to know more? Contact us:
+38 044 364 33 55
+38 044 361 48 28
17-21 Baggovutivska str., 6th floor, 04107, Kyiv, Ukraine