MEDICAL DEVICES REGISTRATION IN UKRAINE
NEWS
25 November 2023
TECHNICAL REGULATIONS FOR AEROSOL SPRAYS
HAS ENTERED INTO FORCE!
On 25.11.2023, the Resolution of the Cabinet of Ministers of Ukraine On Approval of the Technical Regulation on Aerosol Sprays No. 154 dated 21.02.2023 came into force.
The TR was developed on the basis of EU Council Directive 75/324/EEC dsted 20 May 1975.
The TR applies to aerosol sprays with a volume of 50 ml or more.
From now on, the product must be labeled:
-
The mark of conformity to TR 154 - the symbol "inverted epsilon" (indicated in the annex to the TR)
-
Information about the company that puts the product on the market.
-
Net weight and capacity.
-
Information on how much % of the mass is flammable.
-
Warning words.
It is not required to issue a Declaration of Conformity with the requirements of Technical Regulation No. 154. If the medical device, which is an aerosol spray, originates from the EU, testing of such a device in an accredited laboratory is also not required. However, the company placing the product on the market shall analyze, store and provide, upon request of the state market surveillance authorities, documentation of the tests conducted in the EU.
The market surveillance authority that controls the circulation of aerosol sprays is the State Emergency Service of Ukraine (SES).
Link to the relevant Technical Regulation on the website of the Verkhovna Rada of Ukraine: https://zakon.rada.gov.ua/laws/show/154-2023-%D0%BF#n12
15 June 2023
NEW NATIONAL CLASSIFIER OF MEDICAL DEVICES NK 024:2023
HAS ENTERED INTO FORCE!
On June 15, 2023, the Resolution of the Ministry of Economy № 4139 dated May 24, 2023, on the approval of the national classifier NK 024:2023 and the cancellation of NK 024:2019 came into force.
What changes have been implemented: NK 024:2023 is harmonized with the international nomenclature of medical devices Global Medical Device Nomenclature (GMDN).
Why is it important to determine the identification code of a medical device according to the National Classifier: this code must be indicated for registering medical devices with the State Service of Ukraine on Medicines and Drugs Control, as well as when manufacturer or distributor is applying for participation in public procurement/tenders. At the same time, when determining the subject of procurement, NK 024:2023 should be used together with DK 021:2015 "Unified Procurement Dictionary".
The Clients of MED-IMPORT LLC have already received the new National Classifier in PDF format by e-mail. We take care to promptly inform our Partners about changes in Ukrainian legislation.
A link to the corresponding Resolution № 4139 of the Ministry of Economy of Ukraine: https://zakon.rada.gov.ua/rada/show/v4139930-23#Text
01 April 2022
DISPENSING OF ANTIBIOTICS FROM APRIL 1
IS LEGAL ONLY WITH AN ELECTRONIC PRESCRIPTION!
OTHER DRUGS AND SOME MED DEVICES ARE NEXT!
From today April 1, 2022 prescriptions for antibiotics must be issued in the electronic form only.
To get an e-prescription patient should do the following:
-
register in the electronic health care system eHealth (ehealth.gov.ua);
-
contact a doctor of required specialization who is registered in eHealth. It doesn’t matter whether the patient signed a declaration with this doctor or not;
-
apply to a pharmacy that works with eHealth.
Further plan of the Ministry of Health:
-
from August 1, 2022 Ministry has plan to introduce an electronic prescriptions for opiates;
-
from October 1, 2022 - for all other prescription drugs. E-prescriptions most probably will be required for medical devices that are selling with prescription. Prescriptions for med devices are necessary in case of their dispensing free of charge or on preferential terms.
Links to the corresponding Orders of the Ministry of Health:
https://zakon.rada.gov.ua/laws/show/z1371-21#Text
https://zakon.rada.gov.ua/laws/show/z0782-05#Text
24 February 2022
SUPPORT THE ARMED FORCES OF UKRAINE!
Help Ukraine defend itself against military aggression of Russia! The National Bank of Ukraine has opened a special fundraising account to support the Armed Forces of Ukraine. DETAILS:
Donation in USD:
SWIFT Code NBU: NBUA UA UX
JP MORGAN CHASE BANK, New York
SWIFT Code: CHASUS33
Account: 400807238
383 Madison Avenue, New York, NY 10179, USA
UA843000010000000047330992708
Donation in GBP:
SWIFT Code NBU: NBUA UA UX
Bank of England, London
SWIFT Code: BKENGB2L
Account: 40000982
Threadneedle Street, London EC2R 8AH, UK
UA843000010000000047330992708
Donation in EUR:
SWIFT Code NBU: NBUA UA UX
DEUTSCHE BUNDESBANK, Frankfurt
SWIFT Code: MARKDEFF
Account: 5040040066
IBAN DE05504000005040040066
Wilhelm-Epsteinn-Strabe 14, 60431 Frankfurt Am Main,Germany
UA843000010000000047330992708
Donation in UAH:
Bank: The National Bank of Ukraine
Identification Number of the Bank: 300001
UA843000010000000047330992708
USREOU code: 00032106
Beneficiary: The National Bank of Ukraine
10 December 2021
PUBLIC PROCUREMENTS THROUGH INTERNATIONAL ORGANIZATIONS
WILL BE PROLONGED FOR ONE YEAR!
On December 10, 2021, the Bill №6416 was registered in the Verkhovna Rada of Ukraine. There is proposed to prolong public procurement through specialized international organizations for 1 year in the Bill.
Ukraine is currently cooperating with the United Nations Development Program (UNDP) and Crown Agents Limited. The purchase of drugs and medical devices through these companies is allowed until April 30, 2022.
Every year the list of drugs and medical devices purchased through international organizations decreases. Next years the functions of public procurement should be fully transferred to the State Enterprise "Medical Procurement of Ukraine".
A link to the current Law of Ukraine:
https://zakon.rada.gov.ua/laws/show/269-19#Text
A link to the Bill №6416:
http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=73408
18 August 2021
MORATORIUM ON DRUGS AND MEDICAL PRODUCTS ADVERTISING!
The President of Ukraine signed Decree No. 369/2021, which enters into force the Decision of the National Security and Defense Council of Ukraine dated July 30, 2021 about minimizing the harmful effects of self-medication on health.
The Decision provides implementation of a moratorium on the indication of any advertising statements about drugs, medical devices, methods of prevention, diagnosis, treatment and rehabilitation in television and radio, as well as in other mass media from January 1, 2024.
Mass media includes: press (newspapers, magazines, books and other printed publications), Internet media (social media, email, websites, ets.), cinema, radio, television, sound recordings, video recordings, billboards and panels.
26 April 2021
DEADLINE FOR MDR AND IVDR IMPLEMENTATION
IN THE EU COUNTRIES!
For the Notified bodies of the European Union the transition period from the Directives (93/42 / EEC; 98/79 / EC; 90/385 / EEC) to the Regulations expires. Implementation of the Medical Device Regulation №745 began 26 May 2020, In-vitro diagnostic Regulation will begin 26 May 2022. What does this mean for Ukrainian importers, distributors and authorized representatives of medical products manufactured and certified in EU countries?
-
If the products were certified in Ukraine according to the CE certificates recognition procedure and European certificate was changed, the Ukrainian documents will also have to be changed. Products that were certified in accordance with Directives 93/42 / EEC; 98/79 / EC; 90/385 / EEC, can still be imported and distributed on the territory of Ukraine till May 26, 2024.
-
Changes in instructions for use and labels. Not all European notified bodies have received accreditation to provide conformity assessment procedure according to MDR and IVDR. If the manufacturer had to change the notified body, who certifies its products, then there is also necessary to change the notified body identification number on the instructions and labels in Ukraine. The number is indicated next to the CE mark.
You can get more information regarding MDR & IVDR on the European Commission website:
04 January 2021
CHANGES IN THE ORDER OF MAINTENANCE OF THE REGISTER OF PERSONS RESPONSIBLE FOR MEDICAL DEVICES IMPLEMENTATION IN UKRAINE!
On January 4, 2021, the Order of the Ministry of Health of Ukraine No. 2485 dated November 02, 2020 entered into force.
The Order concerns manufacturers of medical devices that are subject to the procedure for self-declaration and entering data into the «Register of persons responsible for the introduction of medical devices, active medical devices for implantation and devices for in-vitro diagnostics into circulation on the territory of Ukraine» (hereinafter the «Register»).
These are the 1st risk class devices (not sterile, without measurement function), as well as devices for in-vitro diagnostics (not for self-control and not included in Lists A, B).
Major changes:
-
From now, the manufacturer / authorized representative in the tables of Annexes 1 and 2 to the Procedure for maintaining the "Register", approved by the Order of the Ministry of Health of Ukraine dated 02.10.2017, must indicate the codes and names of products according to the National classifier NK 024:2019;
-
A period of 10 working days has been approved for submitting a clarifying notification to the State Service of Ukraine on medicines and drugs control. Clarifying notification concerns changes in the initial notification data and / or documents;
-
A detailed procedure for excluding information from the "Register" is approved (in other words, Ministry of Health approved a new procedure for canceling the registration of medical devices that were registered by self-declaration).
You can get information regarding all the innovations in self-declaration from the MED-IMPORT specialists.
A link to the corresponding Order of the Ministry of Health:
https://zakon.rada.gov.ua/laws/show/z1258-20#Text
07 September 2020
NEW LIST OF SPECIALIZED ORGANIZATIONS
THAT WILL PURCHASE IN 2020!
On September 7, 2020, the Cabinet of Ministers of Ukraine approved the list of specialized (international) organizations that will procure medical products from the state budget 2020. The list includes two organizations:
-
Crown Agents Limited
-
United Nations Development Programme
The UNICEF Children’s Fund, which previously also procured goods and services from the state budget of Ukraine, was not included in the list.
A link to the corresponding Resolution No. 790 on the website of the Cabinet of Ministers of Ukraine:
https://zakon.rada.gov.ua/laws/show/790-2020-%D0%BF#Text
01 December 2020
MANDATORY USE OF "INTERNATIONAL SYSTEM OF UNITS"
AT PRODUCT LABELING!
To the attention of manufacturers of medical devices, medical equipment, personal protective equipment, disinfectants! The transition period for application of measurement units other than SI system in labels and in instructions for use is expiring!
From January 01, 2021, in the labeling of these products, the measurement units must be indicated according to the "International System of Units" SI.
Please contact our company specialists to ensure that your products are properly labeled, and attached instructions are in line with current regulations. We will help you to introduce all necessary corrections.
If devices with labeling not following internationally accepted SI system were imported into Ukraine before January 01, 2021, they can be freely sold until the expiration date. Penalties are not applied in this case.
A link to the corresponding Order of the Ministry for Development of Economy and Trade №914:
https://zakon.rada.gov.ua/laws/show/z1022-15#Text
01 July 2020
TECHNICAL REGULATION OF PERSONAL PROTECTIVE EQUIPMENT No. 761
To the attention of manufacturers and importers of personal protective equipment (masks, respirators, protective suits, etc.)!
To participate in public procurement, your products must be certified in Ukraine in accordance with Technical Regulation No. 761, approved by the Resolution of the Cabinet of Ministers of Ukraine of August 27, 2008. The Ministry of Health of Ukraine has determined the Certificate of Conformity as a necessary part of the tender documentation.
Contact "MED-IMPORT" and get information about the certification procedure. Our experts will help to prepare the documentation properly and to get the Certificate of Conformity as soon as possible.
06 May 2020
CHANGES IN THE TECHNICAL REGULATIONS №753, 754, 755
On May 6, 2020, the Cabinet of Ministers of Ukraine approved Resolution №347. It amends the technical regulations for medical devices. The changes concern the conformity assessment procedures and will apply for the period of operation of the Law of Ukraine "On Amendments to Certain Laws of Ukraine to Ensure Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations"
A link to the corresponding Resolution:
03 April 2020
THE TRANSITION TO CERTIFICATION UNDER REGULATIONS
MDR (Medical Device Regulations) & IVDR (in-virto Diagnostic Regulations)
HAS BEEN POSTPONED IN EU COUNTRIES UNTIL 26 MAY 2021!
To the attention of foreign manufacturers and Ukrainian distributors!
The transition from MDD – Medical Device Directives to MDR and IVDR has been extended until 26 May 2021!
This means that medical equipment and medical devices manufactured and certified in the European Union in accordance with Directives 93/42/EEC; 98/79/EC; 90/385/EEC, will be able to be certified in Ukraine under the simplified system - by recognition of the European Certificate by 26 May 2021.
A link to the corresponding regulation:
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589
For more information, contact MED-IMPORT LLC at +38 097 100 00 62 or send us an e-mail: office@med-import.com.ua
01 January 2020
CHANGES IN THE RECOGNITION PROCEDURE
OF CE CERTIFICATES IN UKRAINE!
From May 26 2020 in the European Union countries Directives 93/42 EEC; 90/385 EEC; 98/79 EC will be replaced by:
-
MDR - medical device regulations 2017/745
-
IVDR - in-vitro diagnostic regulations 2017/746
MDR and IVDR are newly developed regulations with toughened requirements for medical devices and medical equipment.
-
The requirements for manufacturers and their authorized representatives will be tighten up.
-
For certain devices, the risk class will be increased.
-
Medical devices cluster will include some products that have not yet been recognized as medical devices (for example: colored contact lenses, disinfectants, devices for laser hair removal, liposuction, etc.).
-
In the EU countries, the UDI system (Unique Device Identifier) will be implemented - a unified system for identifying medical devices.
How these changes will influence the Ukrainian market?
Certificates issued by Ukrainian conformity assessment bodies according to the procedure of “recognition of CE certificates” till 26th of May 2020, will be valid until the end of the CE certificate expiry date. Devices covered by such certificates may be imported to Ukraine up until certificate expires.
CE certificates issued by European notified bodies according to the new Regulations (MDR and IDDR) from 26th of May 2020 will not be recognized in Ukraine. Certification of such products will be possible only through a standard conformity assessment procedure with auditing the manufacturing site.
10 July 2019
TO THE ATTENTION OF MANUFACTURERS OF MEDICAL DEVICES
WITH A MEASURING FUNCTION!
On 10 July 2019, the Cabinet of Ministers of Ukraine approved resolution No. 598. According to the decree, Technical Regulation No. 94 will no longer apply to legally regulated measuring instruments, which are medical devices and/or medical devices for in vitro diagnostics. These changes will come into force on 19 January 2020.
The following items will be excluded from the scope of Technical Regulation No. 94:
-
Medical analyzers: biochemical, hematologic, electrolytes and blood gas, enzyme immunoassay, fluorescent, chemiluminescent, electrochemical.
-
Blood pressure monitor
-
Medical pipet and piston-type dispensers.
-
Electrocardiography.
-
Encephalography.
-
Cardiac defibrillator.
-
Patient monitor.
-
Medical thermometer.
-
Devices for measuring relay protection and automation in the subway.
-
Rheographers.
-
Ultrasonic diagnostic devices.
-
Ophthalmometers.
-
Conductometers, pHmeters, titrators, ionomers used in medical control laboratories (for environmental, phytosanitary and veterinary control the norm remained unchanged).
Since 19 January 2020, these medical devices are subject only to Technical Regulations No. 753 and 754.
25 April 2019
THE VERKHOVNA RADA OF UKRAINE ADOPTED THE NEW LAW «ON PROVISION OF THE FUNCTIONING OF THE UKRAINIAN LANGUAGE AS THE STATE»
The marking, packaging and instructions of medical devices must be aligned with the requirements of this Law. The law comes into force on 16 July 2019. Manufacturers are given a transitional period of 18 months to translate all consumer information into Ukrainian (instructions, packaging, markings, web pages ...). The deadline is 16 January 2021. The clients of MED-IMPORT always know in due time about the specific changes that must be made in the documentation to ensure uninterrupted supplies to Ukraine.
A link to the corresponding Resolution:
06 September 2024
INSPECTIONS OF MEDICAL DEVICES ARE BACK!
Due to the martial law in Ukraine, the market surveillance authorities have not conducted inspections of medical devices since February 24, 2022. Since today, inspections have resumed. After all, the CMU Resolution No. 1052 dated September 06, 2024 came into force, which canceled the moratorium on inspections.
The state body that conducts inspections is the State Service of Ukraine on medicines and drugs control. Places of inspection of medical devices: manufacturers, authorized representatives, importers, distributors, warehouses, pharmacies, healthcare facilities, places of sale and commissioning, fairs, exhibitions, etc.
If violations are detected, the State Service of Ukraine on medicines and drugs control may decide to ban the sale of a medical device in Ukraine, withdraw the product from the market, and impose fines on a business entity (distributor, importer, authorized representative, manufacturer, etc.).
Most often, violations are found in the labeling of a medical device, in the instructions for use, and in the declaration of conformity. To bring these and other documents in compliance with Ukrainian legislation and avoid fines, please contact us at +380971000062 or by e-mail med.import.ukraine@gmail.com
A link to the Resolution No. 1052 on the website of the Cabinet of Ministers: