CONFORMITY ASSESSMENT OF MEDICAL DEVICES IN UKRAINE
+380(44)355-50-30
WELCOME to the official website of the socially responsible body for conformity assessment IMPROVE MEDICAL UA.TR.120, which is accredited by the National Accreditation Agency of Ukraine and appointed by the Ministry of Economy of Ukraine to carry out work to assess the conformity of products within the requirements of technical regulations of the medical devices marketed in Ukraine.
IMPROVE MEDICAL fully supports the European path of Ukraine’s development and welcomes the steps that our country is taking in this direction.
IMPROVE MEDICAL guarantees the performance of work at the level of European standards and principles: openly, impartially and in strict accordance with the letter of the law.
OF COOPERATION
WITH IMPROVE MEDICAL
- Save your time and money by using our wide network with certification and conformity assessment bodies abroad
- Get your products on the market faster by taking advantage of our ability to dispatch your products effortlessly by taking using our service to quickly conduct the necessary trials or service testing.
- Increase the value of your products with the Improve Medical mark, a reliable brand in the field of conformity assessment of medical devices with technical regulations and certification of quality systems.
- Stay updated on all the official industry innovations with our well-established system for informing customers about new regulatory requirements.
The IMPROVE MEDICAL team adheres to the following fundamental principles in its work:
- RESPONSIBILITY We are meticulous about our work and are ready to vouch for the result.
- COMPETENCE High qualification and experience of employees guarantee the reliability of proven results of our work.
- PARTNERSHIP Our employees are ready to answer all your questions regarding both conformity assessment procedures and quality system certification.
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GREETINGS FROM THE HEAD
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BENEFITS
OF COOPERATION
WITH IMPROVE MEDICAL -
HOW WE WORK?
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ISO 9001 QUALITY CERTIFICATION
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ISO 13485 QUALITY CERTIFICATION
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ASSESSMENT OF COMPLIANCE WITH TECHNICAL REGULATIONS ON THE MARKET OF MEDICAL DEVICES
iso 9001:2018 quality management
ISO 9001 QUALITY CERTIFICATION
IIMPROVE MEDICAL has all the necessary powers to carry out the certification procedure in accordance with DSTU EN ISO 9001:2018 Quality Management Systems. Requirements (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT); DSTU EN ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT); ISO 9001:2015 Quality management systems – Requirements) for enterprises operating in such sectors of the economy as:
– healthcare;
– education, etc.
iso 13485:2018 quality management
ISO 13485 QUALITY CERTIFICATION
IMPROVE MEDICAL is an accredited body for the certification of production in accordance with the standards of DSTU EN ISO 13485:2018 Medical devices. Quality Management System. Regulatory requirements (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT); ISO 13485:2016 (Medical devices – Management systems) in the following technical areas:
– active and inactive medical devices;
– implantable medical devices;
– medical devices for laboratory diagnostics in vitro;
– sterilization methods for medical devices;
– products in which special substances/technologies are used.
iso 9001:2018 quality management
ASSESSMENT OF COMPLIANCE WITH TECHNICAL REGULATIONS ON THE MARKET OF MEDICAL DEVICES
IMPROVE MEDICAL is an accredited and conformity designated assessment body for medical devices under the following Technical Regulations:
– Technical regulations for medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2012;
– Technical regulation of medical devices for in vitro diagnostics, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2012;
– The technical regulation on active implantable medical devices was approved by the Resolution of the Cabinet of Ministers of Ukraine No. 755 dated 02.10.2012.
Seminar
IMPROVE MEDICAL specialists will explain the nuances of the current legislation and the practical aspects of their application.
As part of the policy pursued by IMPROVE MEDICAL of the greatest assistance to business entities, the Information Services Centre has been established in the company. By contacting our Centre, manufacturers and suppliers of medical devices are guaranteed to receive comprehensive advice on the following issues:
01.
– The main aspects of the implementation and application of the Technical Regulations for specific medical products. Features and choice of procedure for assessing compliance with TR. Product labelling requirements.
03.
— Regarding the application of the norms of the current Ukrainian legislation on the circulation of medical devices.
02.
– Features of development, implementation and certification procedures according to ISO 9001:2018/DSTU ISO 9001:2018 and ISO 13485/DSTU ISO 13485 for medical devices in Ukraine.
ПОЛІПШИТИ КЕРОВАНІСТЬ ПІДПРИЄМСТВОМ
Система менеджменту якості дозволяє організувати ефективну схему комунікації між усіма підрозділами компанії і, як наслідок, підвищити ефективність управлінських рішень
ПОЛІПШИТИ якість виробленої продукції
Система менеджменту якості дозволяє організувати ефективну схему контролю якості продукції, що випускається і, як наслідок, забезпечити стабільність якісних показників на всіх етапах виробництва
ПОЛІПШИТИ ОБСЛУГОВУВАННЯ КЛІЄНТІВ
Cистема менеджменту якості дозволяє організувати ефективну схему "зворотного зв'язку" з кінцевим споживачем продукції і, як наслідок, підвищити рівень довіри клієнтів до вашої марки медвиробів
INCREASE PROFITABILITY
Industry average profitability
Profitability of certified companies
INCREASE SALES
Industry average sales volume
Sales volume of certified companies
INCREASE PROFIT
Profit per employee, industry average
Profit per employee in certified companies
LEARN THE COST OF WORK
for certification and assessment of compliance with the Technical Regulations on the market of medical devices
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Medical Device Certification in Ukraine: Full Support from Improve Medical
Bringing a medical device to the Ukrainian market is impossible without passing the conformity assessment procedure established by law. Improve Medical is a conformity assessment body for medical devices that supports manufacturers and suppliers at every stage — from consultation on the applicable technical regulation to obtaining the certificate and registering the device.
What Is Conformity Assessment of Medical Devices
Conformity assessment is the official procedure confirming that a medical device meets the safety, quality, and performance requirements set out in Ukraine's technical regulations, which are harmonized with EU directives and the Medical Device Regulation. Without a positive conclusion from a conformity assessment body, a device cannot be placed on the market or put into service in Ukraine.
Our Services
- ISO 9001 and ISO 13485 quality management system certification — confirming that a manufacturer's quality management system meets international standards.
- Conformity assessment of medical devices — covering all risk classes of medical devices.
- Medical device testing laboratory — performing the required tests directly in Ukraine, without delays for shipping samples abroad.
- Registration and consulting — assistance with technical documentation, declaration of conformity, and registration in the relevant registries.
- Training and webinars — regular educational events for quality specialists, regulatory affairs professionals, and technical directors of manufacturing companies.
Why Choose Improve Medical
- Accredited by the National Accreditation Agency of Ukraine — an official conformity assessment body status.
- Experience working with manufacturers of all device classes — from consumables to complex diagnostic equipment.
- Faster time to market thanks to clear support at every stage of the procedure.
- A transparent public registry of issued certificates that can be verified online.
- Personal case manager support from the first inquiry through to receiving your documents.
Frequently Asked Questions
How long does medical device certification take?
The timeline depends on the device's risk class and the completeness of the submitted documentation. It typically ranges from several weeks to a few months.
What documents are needed for conformity assessment?
The basic package includes technical documentation for the device, clinical evaluation data (if applicable), information about the manufacturer's quality management system, and samples for testing.
Do I need ISO 13485 certification if the device already has a CE mark?
Yes. Placing a device on the market in Ukraine requires conformity assessment by a Ukrainian body under the current technical regulations, regardless of existing European marking.
Can device testing be performed in Ukraine?
Yes, Improve Medical operates its own medical device testing laboratory, so you don't have to wait for laboratories abroad.
Still have questions? Contact our specialists — we offer a free consultation on the optimal certification path for your specific device.
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