On November 21, 2025, the Ministry of Health of Ukraine (MoH) approved Order #1771 “On the Approval of the Guideline on Health Technology Assessment (HTA) for Medical Devices” (Guideline).
Experts of AmCham Ukraine Working Group on Healthcare Hardware & Medical Devices Manufacturers provided high-quality expertise and proposals to refine the provisions of the Guideline, including:
- Incorporating the new Regulation 2021/2282 of the European Parliament and Council dated December 15, 2021, on HTA, particularly regarding joint clinical assessments in the requirements for dossier content;
- Expanding the scope of the Guideline to cover in vitro diagnostic medical devices of class D and active implantable medical devices, with clarification on the necessity of conformity assessment;
- Adding the concept of “specific modifications (versions)” of medical devices;
- Specifying indications for inclusion in the Program of Medical Guarantees;
- Replacing the term “generic” medical device with “equivalent.”
AmCham consistently supports the implementation of HTA as an important tool to enhance the efficiency and transparency of decision-making in healthcare.
We are grateful to the MoH and the State Expert Centre of the MoH for considering the business community’s position and for maintaining an open dialogue.
