We have issued digest regarding regulatory environment for medical devices in Ukraine:
1. Accreditation and designation of three conformity assessment bodies for medical devices has been cancelled in 2018: SE “SMCC”, SE “Cherkasystandartmetrolohiya”, “Politoks” LLC. We have summarised their stories and suggested specific actions for the manufacturer or it’s Authorised representative to be taken towards the conformity assessment certificate issued by mentioned bodies.
2. Some medical devices are falling under the scope of certain Technical regulations that recently came into force:
- Technical regulation of legally regulated measuring instruments approved by Resolution No. 94 of the CMU dated 13.01.2016.
- RoHS2: Technical regulations on the restriction of the use of certain hazardous substances in electrical and electronic equipment approved by Resolution No.139 of the CMU dated 10.03.2017;
- RED: Technical regulation on radio equipment approved by Resolution No. 355 of the CMU dated 24.05.2017.
3. Labelling of medical devices placed on the market of Ukraine from 01.01.2019 must comply with requirements of the Order No. 914 of the Ministry of Economic Development dated August 4, 2015 (labelling with SI units).
4. To the end of October half of EU notified bodies for MDD 93/42/EEC signed Agreements on recognition with Ukrainian conformity assessment bodies. List of the EU notified bodies is given in the full text of the digest.
5. We invite you to participate in the seminar on protection against gray import and counterfeit products at December 7, 2018.