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We highlight important regulatory news regarding medical devices in Ukraine in late 2022 and early 2023.<\/p>\n
1. Electronic register of class I medical devices and devices for in-vitro diagnostics\u00a0<\/strong> Notification is submitted by an electronic system through the user\u2019s account, attaching files and applying a qualified electronic signature (QES). Notifications for medical devices manufactured outside Ukraine are signed by an Authorized representative of the manufacturer.<\/p>\n The transition period for submission of notifications in paper format is set until April 10, 2023.<\/p>\n New fields for additional information have been introduced: code and name according to the National Classifier NC 024:2019 and optional fields for the account number and product code according to DSTU EN ISO 9999:2021.<\/p>\n Data transfer from the previous register was carried out by the developers of the electronic system using special software. Complete information on the lists of medical devices in each implemented cell is available only temporarily until April 10, 2023. After this period the data will be deleted from the registry. We recommend market operators review records and resubmit data to maintain access to medical devices in the Ukrainian market.<\/p>\n Links:<\/p>\n Access to the previous registry in Excel format is obsolete.<\/p>\n 2. Unscheduled state market surveillance inspections<\/strong> Unscheduled measures of state supervision (control) are carried out based on decisions of central executive bodies that ensure the formation of state policy in the relevant areas.<\/p>\n 3. Changes to the rehabilitation products\u00a0<\/strong> We remind you that from July 1, 2022, amendments to the Law of Ukraine \u201cOn the Rehabilitation of Persons with Disabilities in Ukraine\u201d established that rehabilitation products fall under medical device regulation. Most rehabilitation products are either class I devices and follow the conformity assessment according to Annex 8, or custom-made medical devices and follow the route set in Annex 9 of the Technical Regulation. All medical devices must comply with the requirements set out in Annex 1 (Essential Requirements), which means the presence of appropriate documentation (Technical File) that contains confirmation of each applicable requirement. The manufacturer must keep the relevant documentation accessible to the state market surveillance authority for at least 5 years after the last product was placed on the market.<\/p>\n Accordingly, we recommend updating the information in the Register of medical devices according to the latest changes in the Order of the Ministry of Social Policy No. 1208 and assuring that all requirements of the Technical Regulations for medical devices are met.<\/p>\n \u201cCratia\u201d offers services of conformity assessment (certification) of medical devices to Technical regulations. We have the necessary knowledge, experience and skills to carry out all the necessary works, perfectly speak and write in English. We will take responsibility for organization of the process, help to form the dossier according to legislation requirements and perform the conformity assessment procedure in the shortest possible time.\u00a0<\/strong><\/p>\n In addition to the main services, we are also ready to offer:<\/p>\n All preliminary consulting are free of charge, contact us by tel.: +38 (044) 364-33-55, 364-30-03, or write to our e-mail:\u00a0info@cratia.ua<\/a>, or visit\u00a0our office<\/a>.<\/p>\n <\/p>","protected":false},"featured_media":1743,"parent":0,"template":"","meta":[],"news_category":[10],"class_list":["post-1983","news","type-news","status-publish","has-post-thumbnail","hentry","news_category-novosti"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news\/1983","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media\/1743"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=1983"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/news_category?post=1983"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nRegister of class I medical devices and IVDs has been transferred into electronic format following changes to Order 122 of the Ministry of Health of Ukraine effective from January 26, 2023. The changes affect the register format which is now no longer an Excel file and the procedure for submitting a notification.<\/p>\n\n
\nOn December 6, 2022, amendments were made to Resolution No. 303 dated March 13, 2022 \u201cOn the termination of measures of state supervision (control) and state market supervision under martial law\u201d which unblocked unscheduled inspections of state supervision (control) during the period of martial law in the following cases:<\/p>\n\n
\nOn January 18, 2023, changes were made to the Order of the Ministry of Social Policy No. 1208 dated August 6, 2019 \u201cOn the organization of providing certain categories of the population with technical and other rehabilitation products\u201d:<\/p>\n\n
\nRehabilitation products intended for free supply to persons with disabilities at the expense of the state budget should be manufactured and supplied by entities included in the Registry of persons responsible for placing of medical devices on the market.<\/p>\n\n