The State Expert Center continues its series of meetings with stakeholders. On 19 March, a meeting was held with representatives of manufacturers of medical devices and medical equipment.
The focus of the discussion was changes in the field of technical regulation, in particular in the context of the accession of State Enterprise "Politekhmed" to the State Expert Center of the Ministry of Health of Ukraine.
During the meeting, the parties discussed:
- the current status of integration
- continuity of procedures
- fulfilment of obligations to applicants
- further organization of work.
The key message conveyed was: the provision of conformity assessment services for medical devices remains uninterrupted.
A topic that is currently of active interest to the market was also touched upon separately: health technology assessment (HTA) for medical devices. The prerequisites for implementation and possible approaches were discussed. Currently, state HTA for medical devices is carried out on a voluntary basis – by the applicant submitting an application and a dossier to the authorized body and paying for expert services.
In conclusion, it was emphasized that the Center is open to discussion and feedback from the market, as this is a necessary condition for predictable and clear processes. We continue to work to ensure that all changes are implemented transparently, clearly and in constant dialogue with the professional community.
