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Health technology supervision transfer to Fimea underway

23 Apr 2019, 19:41 ( 1 Month ago) | updated: 23 Apr 2019, 20:50 ( 1 Month ago)

DF Report
City of Helsinki photo by Kimmo Brandt.

The transfer of the duties concerning health technology supervision from Valvira to Fimea, also including the transfer and reforms of related registers,  are proceeding as planned,said the National Supervisory Authority for Welfare and Health-Valvira in a press release.

The duties that are to be transferred are the supervision of health care devices and equipment (medicinal devices and in vitro diagnostic devices), duties related to the guidance, supervision and registration of biobanks, the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues that currently belong  to Valvira, duties related to embryo research, and the supervision duties related to the Gene Technology Act.

The duties and affiliated personnel will be relocated to Fimea by 31 December 2019.

The aim is to also have the reform project of the register for health care devices and equipment completed by 31 December 2019, after which potential reform projects will be initiated for the biobank and gene technology registers as well.