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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 Government supported the amendments to the Customs Code of Ukraine proposed by the Ministry of Finance to determine the country of origin of goods

On April 7, 2021, the Cabinet of Ministers of Ukraine supported the draft Law "On Amendments to the Customs Code of Ukraine to bring the procedure for determining the country of origin of goods in line with the Customs Code of the European Union" developed by the Ministry of Finance and the State Customs Service. Within the framework of the Associ [...]

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Ukraine introduces a customs information exchange system with the EU, thereby allowing to minimize abuse at customs

The meeting on the reform of the State Customs Service chaired by Prime Minister Denys Shmyhal was held on April 8. Participating in the event were Deputy Prime Minister for European and Euro-Atlantic Integration Olha Stefanishyna, Minister of Finance Serhii Marchenko, Head of the State Customs Service Pavlo Riabikin, and others officials. During [...]

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The Government of Ukraine has established the National Investment Fund

On behalf of the President of Ukraine, the Government established the state enterprise “National Investment Fund of Ukraine” (“National Investment Fund”) and approved its charter. The relevant decision was made at a meeting of the Cabinet of Ministers on March 31. The purpose of the National Investment Fund is to create favorable conditions for [...]

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The State Regulatory Service of Ukraine has issued an explanation regarding the ban on conducting scheduled inspections of business entities by state supervision (control) bodies during quarantine

The prohibition on carrying out planned measures of state supervision (control) in the sphere of economic activity is established by the Law on Support of Taxpayers. However, the current legislation no longer provides for a total ban on business inspections, as it was before. Therefore, today it is forbidden to conduct scheduled inspections by sta [...]

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The Antimonopoly Committee of Ukraine has provided explanatory notes on the content of advertising of medicines

The indications and properties of the medicinal product must be correctly stated in the advertising message and correspond to the information specified in the instructions for use of the medicinal product. This is stated in the recommendations of the Committee on the application of the provisions of Article 15-1 of the Law of Ukraine "On Protectio [...]

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The Ministry of Health of Ukraine has submitted for public discussion the draft of the updated National Classifier NC 024: 2019 “Classifier of medical devices”

On April 6, 2021, the draft of the updated National Classifier NC 024: 2019 “Classifier of Medical Devices” (hereinafter - NC 024: 2019) was published on the website of the Ministry of Health of Ukraine. The current version of NC 024: 2019 was approved by the order of the Ministry of Economic Development and Trade of Ukraine dated 05.02.2019 № 159 [...]

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Crown Agents and UNDP will purchase drugs and medical devices in 2021

During the Government meeting on March 31 adopted a resolution that approved the list of specialized organizations that carry out procurement of drugs and medical products in 2021. They are: Crown Agents Limited, United Nations Development Program (UNDP). The act is published at the link. [...]

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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.

read more

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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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