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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 Ministry of Economy of Ukraine has developed a draft resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Description of the Mark of Conformity to Technical Regulations”

The draft act was published on the website of the Ministry of Economy on September 11, 2020, at the link. Thus, it is proposed to make the following changes to the description of the mark of conformity to technical regulations, approved by the Cabinet of Ministers of Ukraine dated December 30, 2015, № 1184 “On approval of the form, description of [...]

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The Government has published the text of the August resolution of the Cabinet of Ministers on the development of the emergency medical care system in 2020

Resolution of the Cabinet of Ministers № 818 "Some issues of development of the emergency medical care system in 2020" came into force on September 12, 2020. The act, in particular, approved the list of medical devices and accessories for them, systems of medical devices, procedural kits purchased from the state budget for the development of emerg [...]

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The draft sectoral plan of state market supervision for 2021 has been published.

On October 29, 2020, the State Medical Service of Ukraine as a body of state market supervision of medical devices published a draft sectoral plan of state market supervision for 2021, adding a justification to it. Thus, during the development of the draft sectoral plan of DLS, the types of products are considered to be at increased risk, the resu [...]

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The government has finally abolished the list of medical devices whose supply operations in the customs territory of Ukraine and importation into the customs territory of Ukraine are subject to value added tax at the rate of 7 percent.

Thus, the relevant resolution of October 28, 2020 № 1009 "On repealing resolutions of the Cabinet of Ministers of Ukraine of September 3, 2014 № 410 of November 11, 2015 2015 923" is repealed from the system of obsolete regulations acts that do not contain a functional load and legal value, but could only confuse market operators with their validity. [...]

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State Medical Service starts unscheduled inspections of medical devices intended for in vitro diagnostics COVID-19

The State Service of Ukraine for Medicinal Products and Drug Control (hereinafter - the State Medical Service) informs that the territorial bodies of the State Medical Service have started unscheduled inspections of the characteristics of introduced products intended for in vitro diagnosis of acute respiratory disease COVID-19 caused by SAR. In pa [...]

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The Ministry of Health has developed changes to the procedure for state registration (re-registration) of disinfectants

On November 5, the Ministry of Health of Ukraine published for public discussion a draft resolution of the Cabinet of Ministers of Ukraine "On Amendments to the Procedure for State Registration (Re-registration) of Disinfectants" (hereinafter - the draft resolution). The accompanying documentation to the project states that the current procedure o [...]

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STS launches a new service “infoTAX”

Starting November the State Tax Service of Ukraine launches a new electronic service "infoTAX". This was announced by Chairman of the State Tax Service Oleksii Liubchenko during a joint briefing with the Deputy Prime Minister - Minister of Digital Transformation Mykhailo Fedorov. At the first stage of this service, payers with the help of Telegram [...]

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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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+380 (95) 692 26 08

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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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