The Information Services Center of IMPROVE MEDICAL has prepared specially for you next news digest in respect of “medical products”, where we inform you about the following:
- In order to reduce administrative pressure on businesspeople, elimination of the excessive state intervention in the economic processes and deregulation of medical products pricing, from March 13, 2019, medical products prices regulation was abolished in respect of those that are purchased at the expense of budget funds.
Relevant changes were made to the Resolution No. 955 of the Cabinet of Ministers of Ukraine of October 17, 2008 “On measures to stabilize the prices of medicines and medical devices” by the Resolution No. 184 of the same name of March 6, 2019, the text of which is published at link.
Consequently, it is expected that the abolition of surcharges for medical products will offer an opportunity for the development of competition in the market, consequently expanding the range and improve the quality of products when it comes to procurements.
Besides the complete abolition of the medical products prices controls, in particular, the amendments provide for the mandatory monitoring of the medical products prices, and functionally charging with it the Ministry of Health of Ukraine.
Information on results of the monitoring and proposals for improving of the state regulation of medical products prices should be submitted to the Cabinet of Ministers of Ukraine within a year – before March 1, 2020.
According to the Association AMOMD, which furthered this initiative, the item was a requirement of the Ministry of Finance of Ukraine during adoption of these amendments.
You can learn more details at link.
- On February 5, 2019, the Order No. 159 of the Ministry of Economic Development and Trade of Ukraine approved NC 024: 2019 “Classifier of medical devices”.
The Classifier of medical devices is designed to introduce the naming system used for interchange of information about medical devices; it is fully harmonized with the Global Medical Device Nomenclature (GMDN).
The objects of classification are medical devices used to diagnose, prevent, monitor, treat or alleviate human diseases and injuries.
Maintenance of NC 024: 2019 is carried out by the State Ukrainian Association “Politekhmed”.
Currently, the Classifier is informational, in the future – development of a specific regulatory framework and introduction of these codes into the PROZORRO system for public procurement and specification of the subject of the medical products procurement is planned.
The Qualifier is available at link.
- The State Service of Ukraine on Medicines and Drugs Control published its Report on market supervision in 2018.
In 2018, regional offices of the State Service of Ukraine on Medicines and Drugs Control performed 867 planned and 220 extraordinary inspections of products characteristics. According to the results of the performed inspections of products characteristics, 344 decisions were made on restrictive (corrective) measures.
As the Association AMOMD informs, punitive sanctions are imposed on 155 economic agents at the rate of 806,320 UAH.
The Report is available at link.
- The State Enterprise “Ukrainian Research and Training Center of Standardization, Certification and Quality” (SE “UkrNDNC”), being the national standardization body, will conduct inspections of national regulatory documents according to the published plan.
The State Standards of Ukraine in respect of medical devices and disinfectants are among these documents.
According to the Plan, verification of these standards is expected to be completed by December 2019.
More detailed information on inspection plans is available at link.
- On the website of the Ministry of Health of Ukraine, the Order is posted approving new lists of National Standards, compliance with which provides the presumption of products conformity to the Technical Regulations for medical devices, active medical devices, implantable medical devices, diagnostic and in vitro diagnostic medical devices (No. 294 of February 05, 2019 “On amendments to some Orders of the Ministry of Health of Ukraine”)
The list is available at link.
- The procurement of medicines and medical devices with the involvement of international organizations was extended until December 31, 2020.
Relevant changes have been made to the Order of Ukraine “On the Government Budget of Ukraine for 2019”.
As a result, amendments were also introduced into the relevant to the medical market Technical Regulations by the Resolution No. 279 of the Cabinet of Ministers of Ukraine of March 27, 2019:
- No. 753 of October 02, 2013 – “On approval of the Technical Regulations for medical devices”;
- No. 754 of October 02, 2013 – “On approval of the Technical Regulations for in vitro diagnostic medical devices”;
- No. 755 of October 02, 2013 – “On approval of the Technical Regulations for active implantable medical devices”.
The amendments provide for the possibility of introducing into circulation medical devices purchased by organizations without affixing a conformity mark, subject to recognition of the results of conformity assessment with the requirements of technical regulations performed by accredited foreign conformity assessment bodies.
These amendments came into force on April 1, 2019 and will be in effect until March 31, 2020.
The Law of Ukraine “On Technical Regulations and Conformity Assessment” stipulates that national conformity assessment bodies have the right to recognize such results of conformity assessment on the basis of contracts concluded with foreign conformity assessment bodies, provided that:
– National accreditation bodies for conformity assessment bodies, both in Ukraine and in another state, are members of an international or regional accreditation organization and / or have entered into an agreement on mutual recognition with such an organization regarding relevant types of conformity assessment activities;
– on the basis of a Certificate of conformity issued by a foreign conformity assessment body, the designated body applies a conformity assessment procedure or a part of it, and issues a conformity Certificate provided for by this procedure on its own responsibility.
It should be emphasized, that in the portfolio of IMPROVE MEDICAL, there are already 25 signed agreements on recognition of results of the medical devices conformity assessment.
The list of medicines and medical devices procured under procurement agreements with specialized organizations that make such purchases in the areas of budget funds use in 2019 under the program “Ensuring the implementation of medical measures of certain government programs and comprehensive program activities” was approved.
Appropriate Resolution No. 255 of the Cabinet of Ministers of Ukraine of March 13, 2019 came into effect on April 3.
Altogether, 80 lines of procurement were approved, among which:
- medicines for children with nanism of various origins;
- medications for citizens suffering from Gaucher disease;
- medicines and small laboratory equipment to ensure the treatment of female infertility with methods of assisted reproductive technology;
- anti-D immunoglobulin to prevent haemolytic disease of the newborn;
- medicines for citizens suffering from mucopolysaccharidosis;
- medicines for citizens suffering from orphan metabolic diseases;
- medicines and medical devices for patients in the transplantation pre- and postoperative period;
- medicines for children with infantile cerebral palsy;
- medications for the treatment of patients with multiple sclerosis;
- medications, radiopharmaceuticals and accompanying medications for the treatment of cancer patients;
- medicines for treatment of children with haemophilia B, etc.
- IMPROVE MEDICAL UA.TR.120 remains actively seized of pushing back the limits in collaboration with international conformity assessment bodies
In February 2019, we signed agreement on unilateral recognition of compliance assessment results with BSI Group the Netherlands B.V. (John M. Keynesplein 9, Unit 4.2 1066 EP Amsterdam, the Netherlands), registration number NB 2797.
Manufacturers who have transferred from the notified body BSI Assurance UK Limited (0086) to the notified body BSI Group the Netherlands B.V. (2797), received EU Certificates, can be provided in IMPROVE MEDICAL Certificates about passing the conformity assessment procedure by recognizing the results of EU Certificates.
IMPROVE MEDICAL performs conformity assessment procedures by recognizing the results of international notified bodies and is prepared to prevent consultations, as well as the need for a practical case portfolio.
- At the 8th Ukrainian Forum of the Medical Devices Market Operators, Myroslava Boichuk, Director of IMPROVE MEDICAL, made a presentation on transition to the new version of the National Standards of Ukraine EN ISO 13485: 2018 (EN ISO 13485: 2016, IDT; ISO 13485: 2016, IDT).
In her presentation, Myroslava focused on complaints and reporting to regulatory authorities, and also answered participants’ questions that came up during her presentation.
You can watch the video-recording of M. Boichuk’s speech by clicking on the link.
If you have any clarifying questions or need an advice, you can contact the IMPROVE MEDICAL office.
- IMPROVE MEDICAL provided partner support in organizing and carrying out the 8th Ukrainian Forum of the Medical Devices Market Operators – a specialized annual event of the Association AMOMD, whose member IM has been since 2016
At the moment, the first part of a series of publications has been issued, where questions of the medical products market price and tax regulation, public procurement and implementation of the regulatory policy of the Ministry of Health in this market are revealed.
The article is available at link.
- the Information Services Centre of IMPROVE MEDICAL announces topical events:
– On April 11 (Thursday) at 11:00 am, a webinar on topical issues of post-marketing clinical evaluation and regulatory changes in the turnover of medical devices in 2018-2019 will take place.
The following questions will be revealed:
- What is a post-marketing clinical evaluation, and what is its importance with regard to the quality and safety of MD?
- Program and methods for post-marketing clinical assessment.
- Focal points to the plan and report of the post-marketing clinical assessment.
- Decisions taken by manufacturer in virtue of the results of post-marketing clinical evaluation.
- Examination by a conformity assessment body of post-marketing clinical assessment results.
- Control and supervision over medical products in 2018 and the trend of inspections in 2019.
- The status and prospects for the introduction of the Ukrainian Classifier of medical devices and the market impact.
- What should market operators know about the state of the new EU regulations with regard to medical devices implementation in Ukraine?
- Forecast of changes in the regulatory field of the medical products turnover in 2019.
Speakers of the Webinar:
- Svetlana Zgonnyk, Head of the Conformity Assessment Department of IMPROVE MEDICAL
- Darya Bondarenko, Executive Director of the Association AMOMD
Language: Ukrainian/Russian. Conditions of participation: event on a paying basis – 1000 UAH (exc. VAT).
The Webinar sign up is open at link.
– On May 16 (Thursday), at 11:00 am, the Webinar “Recognition of the results of medical devices conformity assessment performed in the EU” will take place, speaker – Svetlana Zgonnyk, Head of the Conformity Assessment Department of IMPROVE MEDICAL.
Language: Ukrainian/Russian. Conditions of participation: the ivent is charge-free.
The Webinar sign up – at link.
If you have any questions, do not hesitate to contact us by e-mail: email@example.com or by phone: +38073 355 50 30 (whatsapp, viber, telegram, wechat).