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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

On February 24, 2021, the Government of Ukraine considered the draft resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine of December 3, 2009 № 1301”

Thus, amendments to the Resolution of the Cabinet of Ministers of Ukraine of December 3, 2009 № 1301 “On Approval of the Procedure for Providing Persons with Disabilities and Children with Disabilities by Technical and Other Means” were developed to expand the list of medical devices and other aids for persons with disabilities. disability and certai [...]

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On 24.02.2021, the Government of Ukraine considered the draft resolution of the Cabinet of Ministers “Some issues of implementation of the Law of Ukraine“ On transplantation of anatomical materials to humans ”on bioimplants, xen implants, medical and biological requirements for animals, conditions of their detention»

The act provides for the approval of: - procedure for manufacturing, quality control and circulation of bioimplants; - procedure for manufacturing, quality control and circulation of xen implants; - medical and biological requirements for animals, conditions of their keeping, the order of extraction of anatomical materials from animals for the m [...]

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On February 17, the government adopted Resolution 32132 “Some issues of procurement of medicines, medical devices and their aids purchased in 2021

This act approves: the list of medicines, medical devices and auxiliaries to them, which are purchased for the implementation of relevant agreements (contracts) concluded by the person authorized to procure in the field of health care for the implementation of programs and implementation of centralized health care measures by areas of use budget [...]

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Resolution of the Cabinet of Ministers of 15.02.2021 № 118 amended the list of goods (including medicines, medical devices and / or medical equipment) necessary to implement measures aimed at preventing the occurrence and spread, localization and elimination of outbreaks, epidemics and pandemics of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2, operations on import of which into the customs territory of Ukraine and / or operations on supply in the customs territory of Ukraine are exempt from value added tax (hereinafter – the List)

The document came into force on February 19, 2021 in connection with the publication in the newspaper "Governmental Courier" 34 of February 19, 2021. The changes affected the section "Consumables for medical care for patients with COVID-19 and medical devices for vaccination against COVID-19". Thus, the position of "disposable, sterile syringes [...]

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The Cabinet of Ministers of Ukraine has approved the Technical Regulations for cosmetic products

As noted in the explanatory note to the resolution, the Technical Regulation on cosmetic products sets new requirements for the circulation and safety of cosmetic products and provides for the use of the latest technological developments, alternative methods of testing cosmetic products, market surveillance of product compliance. At the same time, [...]

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Ihor Petrashko held an interdepartmental meeting on the progress of preparations for the conclusion of industrial visa-free regime

February 1, 2021, the Ministry of Economic Development, Trade, and Agriculture was the venue for an interdepartmental meeting dedicated to the progress of preparations for the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA). The event was chaired by the Minister of Economic Development, Trade, and Agriculture of Ukra [...]

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Ministry of Finance presents a detailed analysis of the use of the COVID Response Fund in 2020 by the main budget institutions

In 2020, the number of funds allocated from the COVID-19 Response Fund made up UAH 78.4 billion out of UAH 80.9 billion. In particular, from the general fund there was used UAH 63.7 billion out of the allocated UAH 72 billion, the special fund - UAH 2.8 billion out of the allocated UAH 6.4 billion. The largest recipients of funds were: • The Stat [...]

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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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