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UA’ MARKET LEADER IN
CRO & REGULATORY POLICY
OF MEDTECH MARKET, WE OPEN UKRAINE
FOR YOU MORE QUICKLIER
THAN OTHERS

GET CONSULTATION

WELCOME TO JERELO!

If you are looking for a competent partner to manage your clinical research project in Ukraine, JERELO is at your service.

JERELO represents a contract research and development organization providing a full range of services for the medical device launch on the  market.

JERELO offers a wide variety of services, including but not limited to the following: organization and implementation of a clinical trial through phases I to IV, a full life cycle of medical products (design development, the product launch on the market), engineering and consulting services for further development of medical devices.

We provide services not only in the field of clinical trials but also regarding the medical device regulatory compliances in Ukraine.

Having in-depth knowledge of regulations and guidelines relevant to the medical device industry, we are qualified to assist you with setting up the device, improving the production process, and making the device suitable for the industry.

We are JERELO – your reliable and trustworthy partner for medical device business development!

WANT TO GET CONSULTATION?

Daria Abulova
Regulatory Affairs Specialist

daria.abulova@jerelo.eu

+380 (95) 692 26 08

Our services include the following:

Product Development R&D

The combination
of the mentioned services in one CRO, enables

MISSION:

Our mission is to promote technological innovations in the field of medical devices, to facilitate access to the medical device market in Ukraine, and ease successful pathways through all stages before the product launch.

VISION:

Our vision is to contribute in improving patients life, by helping
and encouraging the manufacturers to develop advanced devices meant
to increase people’s quality of life

WHY SHOULD I CONDUCT CLINICAL STUDIES IN UKRAINE ?

Why to conduct clinical studies With JERELO?

There have been significant improvements in legislative and regulatory aspects over the past few years.

Therefore, Ukraine provides a beneficial environment for conducting clinical trials:



High quality
of data


confirmed by numerous FDA/EMA audits

800 specialists
A large pool of highly
motivated, experienced,
and GCP-trained clinicians


International standardsfor medical care


2500
Public healthcare system comprising over 2,500 public healthcare facilities


A large pool
of potential study subjects

Based on the results of the European Business Association investment research, the Ukraine’s investment potential has finally been overturned and is currently demonstrating an increasing growth.

Ongoing medical reform is another major step that is currently being implemented in Ukraine. The new model proposed by the MOH is based on the UK’s healthcare system and includes implementation of state funded medical insurance for all Ukrainians and establishment of a safe, stable, and guaranteed system, which will raise the Ukrainian healthcare level.

JERELO collaborates with:

Ukrainian Children’s
Cardiac Center (UCCC)

Kiev Heart Center

A. A. Shalimov National Institute
of Surgery and Transplantology

Kiev City Oncology Hospital

Hospital
Management

Veterinary clinic
VetLab

Area
of expertise

Our expertise covers from class I to class III devices in a wide range of disciplines:

Interventional Cardiology Oncology
Dentistry Orthopedics
Gastroenterology Surgery
Neurology & Neurovascular Vascular other (Venous, Peripheral)

JERELO possesses extensive experience in medical device studies in various therapeutic areas. Thorough knowledge and understanding of specific device characteristics ensure successful outcomes of your clinical trial. The establishment of a vast network of Key Opinion Leaders in Ukraine enables us to select the right conditions for your research project.

OUR EXPERTISE THROUGHOUT THE MEDICAL DEVICE LIFE CIRCLE

Bench
tests
Animal
Study
Manufacture
Conformity Assessment
Concept
Design
Feasibility
and Proof
of Concept
Quality
System
Launch
Clinical Study
Post Market

JERELO represents a full-range CRO that provides services starting from the medical device development to the regulatory submissions in Ukraine. Furthermore, the product launch on the Ukrainian market and post-market surveillance management is also included in the service.

We can provide simple advisory assistance as well as the full strategic analysis of the regulatory requirements on clinical studies and submissions.

The level of expertise ensures our partners to get smooth access to the Ukrainian market.

JERELO is qualified to accurately identify the issue and offer a relevant solution to develop the plan of action efficiently.

MORE TO READ

WE ARE TRUSTED BY :

Testimonials

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We believe that expectations are higher for CRO’s able to identify issues early, offer solutions, and efficiently implement changes

This is what JERELO adheres to

BLOG
NEWS

The State Medical Service of Ukraine has published a sectoral plan of state market supervision for 2021

The document is available for download at the link. During the development of the sectoral plan, DLS takes into account the affiliation of products to a high degree of risk, the results of monitoring the causes and number of cases of harm to human health due to consumption (use) of products, analysis of information obtained through international r [...]

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The Ministry of Health is developing a mechanism to reimburse the cost of medical devices for patients with diabetes

According to the Ministry of Health of Ukraine dated 20/11/2020, under the chairmanship of the First Deputy Minister of Health of Ukraine Iryna Sadovyak, a meeting was held on the introduction of a pilot project of state regulation of prices for medical devices for diabetics and reimbursement. The event was attended by experts from the Ministry of He [...]

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The Government of Ukraine adopted a resolution dated December 16, 2020 № 1251 “On the allocation of funds to provide health care facilities in hospital districts with medical equipment, namely X-ray diagnostic systems of general purpose (digital) and ultrasound diagnostics.”

Thus, according to the text of the resolution, the Ministry of Health was allocated 1,049,650,000 hryvnias (development expenditures) on a non-refundable basis from the COVID-19 Acute Respiratory Disease Fund caused by SARS-CoV-2 coronavirus and its consequences for certain measures aimed at preventing the occurrence and spread, localization and elim [...]

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The fifth meeting of the EU-Ukraine Association Committee took place in the trade composition: the Ministry of Economy of Ukraine

On December 8-9, 2020, the fifth meeting of the EU-Ukraine Association Committee took place in the trade composition by video conference from Kyiv to Brussels. During the intensive two-day work, the parties discussed a range of issues related to the implementation of Section IV "Trade and Trade-Related Issues" of the EU-Ukraine Association Agreeme [...]

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The Draft Law on Amendments to the Criminal Code of Ukraine on Liability for Counterfeiting of Medical Products and Similar Crimes Threatening Health Care has been registered

The Draft Law on Amendments to the Criminal Code of Ukraine on Liability for Counterfeiting of Medical Products and Similar Crimes Threatening Health Care (hereinafter referred to as the Draft) has been registered. The project was registered in the Verkhovna Rada of Ukraine on 14.12.2020 № 4491, the text and accompanying documents are posted at th [...]

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The Ministry of Health has approved an action plan for the preparation of draft regulatory acts for 2021

The Ministry of Health of Ukraine by order of 15.12.2020 № 2885 approved the Action Plan of the Ministry for the preparation of draft regulatory acts for 2021 (hereinafter - the Plan). The full text of the Plan is available at the link. In particular, during 2021 in the market of medical devices the Ministry of Health plans to develop: in [...]

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The Government amended item 12 of the Resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 № 333 “Some Issues of State Regulation of Prices for Medicinal Products and Medical Devices”

On December 16, 2020, the Government of Ukraine adopted Resolution of the Cabinet of Ministers № 1253. The text is posted at the link. The text of the act stipulates that the requirements of the Resolution of the Cabinet of Ministers of Ukraine № 333 of 25.03.2009, in particular, do not apply to the procurement of goods, works and services nece [...]

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FAQ

State regulation of prices for some goods and anti-epidemic goods: up-to-date.

Comment

On May 18, the Resolution of the Cabinet of Ministers of April 22, 2020 № 341 came into force, which defines the mechanism for declaring changes in retail prices for goods of significant social significance and anti-epidemic goods. Declaration of changes in retail prices is introduced in case of price increase, compared to the price […]

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How to indicate what MD’s are subject to self-declaration?

Comment

According to Technical Regulations on medical devices, class I medical devices, non-sterile and without a measuring functions are subject to self-declaration. In line with the Technical Regulations on medical devices for in vitro diagnostic, all MD’s which don’t fall under the list A and list B classification and are not intended for self-control are subject to self-declaration

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Which act should govern a medical device with a medicinal substance?

Comment

The operation of medicines in Ukraine is covered by the Law of Ukraine «On Medicines». I have already defined in previous videos that MD’s are subject to Technical Regulations and other acts. And the Law of Ukraine «On Medicines» doesn’t cover on medical devices (neither in vitro diagnostic devices, nor active implantable devices).

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I don’t have a conformity assessment certificate according to Technical regulations. Can I place on market a medical device without applying to the CAB to proceed a CAP?

Comment

Yes, you can put your MD into circulation in Ukraine without involving a CAB in one and the only case – your medical device is I class risk (non-sterile and without measuring function).

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Is it possible to obtain a certificate without the on-site audit?

Comment

There are two options to proceed the CAP and to avoid on-site audit of the manufacturer: 1. Recognition of CE Certificate. 2. Proceeding batch certification.

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Do I have to proceed with a CAP in Ukraine if I already have a CE Certificate?

Comment

The existence of CE Certificate doesn’t provide any preferences — Ukrainian legislation requires to proceed the conformity assessment procedure under the Ukrainian TR’s even for those manufacturers that possess a CE Certificate.

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Who is the Authorized representative?

Comment

The essential requirement for the manufacturer which is not the resident of Ukraine, is to appoint the authorized representative.

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What is the procedure of conformity assessment?

Comment

Conformity assessment procedure – any procedure used to determine that prescribed requirements in relevant technical regulations or standards are fulfilled.

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What regulations govern the conformity assessment procedure in Ukraine?

Comment

Since 1 July 2015, it has become
a mandatory requirement that medical devices, must be subject
to the assessment of conformity with the Technical regulations (TR) before being placed on the Ukrainian market.

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Who is entitled to proceed the conformity assessment procedure of medical devices in Ukraine?

Comment

In accordance with the Law of Ukraine
“On Technical Regulations
and Conformity Assessment”,
the conformity assessment procedure
is made by the Conformity Assessment Body, an organization which confirmed its competence, proceeded
the accreditation procedure,
and therefore can perform conformity assessment.

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CONTACT Us

33B, Shota Rustaveli str., Kyiv, 01033, Ukraine

+380 (95) 692 26 08

daria.abulova@jerelo.eu

Mon - Sat | 9am - 8pm

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