Conformity Assessment in Ukraine
Заголовок
To pass the conformity assessment for medical devices in Ukraine, you need to meet the requirements of the Technical Regulations for medical devices No. 753, the Technical Regulation for in vitro medical devices No. 754, or the Technical Regulation for active implantable medical devices.
The primary method for introducing medical devices to the Ukrainian market is through the import of devices from abroad. In this case, you must have an Authorized Representative within Ukraine. If the manufacturer is located in Ukraine, an Authorized Representative is not required.
In both cases, you need to undergo a conformity assessment procedure with a conformity assessment body (for classes Is, Im, IIa, IIb, and III) or be included in the Register of entities responsible for the introduction of medical devices on the Ukrainian market (for class I).
Етапи співпраці
Консультація та підготовка
Спеціалісти проводять консультації з клієнтом для з'ясування всіх деталей та вимог стосовно реєстрації. Згідно з отриманою інформацією, підприємство готує всі необхідні документи та заявку на реєстрацію.
Реєстраційний процес
спеціалісти проводять реєстраційний процес згідно з вимогами місцевого законодавства та міжнародних стандартів. Це може включати як розробку документації системи управління якістю, так і заповнення різних форм, проведення досліджень та тестувань, формування декларацій, формування етикеток, та ін.
Пост-маркетинг
після реєстрації продукції, спеціалісти допоможуть впровадити систему нагляду за продукцією після виходу продукту на ринок (прийом та обробка скарг, відгуки тощо)
Заголовок
In the conformity assessment process, a state-accredited conformity assessment body evaluates the characteristics of the medical device and the manufacturer’s quality system. Based on the results, a certificate of conformity is issued for your product. There are two main methods for conducting the conformity assessment by the body:
- Recognition of the conformity assessment results performed in the EU (recognition of CE certificate)
- On-site audit (or remote audit)
Each method has its own advantages and disadvantages. Below is a comparative table of CE certificate recognition and on-site (remote) audit:
| Recognition of CE Certificate | On-site Audit | ||
| Advantages | Disadvantages | Advantages | Disadvantages |
| Does not require an on-site visit | Issued for the duration of the CE certificate | Certificate is issued for 5 years | Requires an on-site visit |
| Faster process | Cannot include products not covered by the European certificate | All product groups can be included in one certificate | Additional travel and accommodation costs for auditors |
| Lower cost compared to on-site audit | Cannot combine multiple CE certificates from the same manufacturer into one | Most documents can be reviewed at the facility | Certification audit takes at least 2-3 days |
Заголовок
News
The Director of Med Quality conducted a training on the requirements of ISO 13485:2016 on April 2, 2025.
Med Quality's CEO Vladyslav Kasyanenko hosted webinar on the topic "Conformity assessment of medical devices in Ukraine"
