Regulatory news on medical devices in Ukraine

We highlight important regulatory news regarding medical devices in Ukraine in late 2022 and early 2023.

1. Electronic register of class I medical devices and devices for in-vitro diagnostics 
Register 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. 

Notification is submitted by an electronic system through the user’s 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. 

The transition period for submission of notifications in paper format is set until April 10, 2023.

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.

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. 

Links:

• the new address of the register of persons responsible for the placing of medical devices,
• user manual,
• user’s cabinet.

Access to the previous registry in Excel format is obsolete. 

2. Unscheduled state market surveillance inspections
On December 6, 2022, amendments were made to Resolution No. 303 dated March 13, 2022 “On the termination of measures of state supervision (control) and state market supervision under martial law” which unblocked unscheduled inspections of state supervision (control) during the period of martial law in the following cases:

• in the presence of a threat to human rights, legitimate interests, life, and health;
• environmental protection;
• ensuring state security;
• to fulfill Ukraine’s international obligations.

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.

3. Changes to the rehabilitation products 
On January 18, 2023, changes were made to the Order of the Ministry of Social Policy No. 1208 dated August 6, 2019 “On the organization of providing certain categories of the population with technical and other rehabilitation products”:

• the names and codes of the products are aligned with DSTU EN ISO 9999:2021 “Assistive products for persons with disabilities. Classification and Terminology”;
• marginal prices for assistive products of rehabilitation (technical and other rehabilitation products) were increased; 
• the section “Product code and/or manufacturing options” has been deleted.

We remind you that from July 1, 2022, amendments to the Law of Ukraine “On the Rehabilitation of Persons with Disabilities in Ukraine” established that rehabilitation products fall under medical device regulation. 
Rehabilitation 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. 

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. 

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. 

“Cratia” 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. 

In addition to the main services, we are also ready to offer:

• Outsourcing of the service of the Authorised Representative of the manufacturer in Ukraine;
• Legal support of the manufacturer, authorised representative or distributor (importer);
• Development and implementation of QMS according to ISO 9001 and ISO 13485; 
• Development technical and medical documentation, conduction of testing and research; 
• Construct an effective protection against gray imports (counterfeit products).

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: info@cratia.ua, or visit our office.