Laboratory Testing of Medical Devices
Laboratory testing of medical devices that share a similar form with cosmetic products
CoLab is a modern testing laboratory in Kyiv specializing in the testing of cosmetic products and raw materials, medical devices, and cosmetic products for animals.
Some medical devices have a dosage form and method of use similar to cosmetic products (creams, gels, solutions, sprays). The CoLab laboratory carries out laboratory testing of such medical devices, in particular for inclusion in the technical documentation for certification purposes.
Our test reports form the basis for regulatory documentation, safety assessment, and substantiation of a product's claimed properties. We carry out laboratory testing whose results are used to demonstrate the conformity of products with the requirements of the technical regulations of Ukraine, the European Union, the United Kingdom, and other international markets.
Forms of medical devices we test:
Regulatory Requirements
In Ukraine, medical devices are regulated by the Technical Regulation on Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 of 02.10.2013, and are subject to a mandatory conformity assessment procedure before being placed on the market.
As part of the conformity assessment, a technical file must be developed for the medical device, containing:
National Standards
In accordance with clause 9 of the Technical Regulation, medical devices that meet the requirements of the national standards included in the list are deemed to comply with the requirements of the Technical Regulation. The list includes monographs (pharmacopoeial articles) of the State Pharmacopoeia of Ukraine.
Regulatory Documents
- Resolution of the CMU No. 753 Technical Regulation on Medical Devices (02.10.2013)
- ДФУ 2.8 State Pharmacopoeia of Ukraine
- Eur Ph 11.8 European Pharmacopoeia
Organoleptic Parameters
Organoleptic parameters are fundamental characteristics of medical devices that are assessed at all stages of the life cycle. They play a critically important role both in terms of stability and in terms of safety and consumer perception.
Physicochemical Parameters
Microbiological Parameters
Stability and Compatibility
Order Medical Device Testing
The CoLab laboratory carries out comprehensive testing of medical devices, the results of which form a scientifically substantiated body of evidence and serve as the basis for the technical documentation (technical file) for the conformity assessment procedure.