Ukraine | Draft Order of the Ministry of Health of Ukraine "On approval of the Procedure for putting into circulation and operation of certain medical devices, in vitro diagnostic medical device...

Title of document
Draft Order of the Ministry of Health of Ukraine "On approval of the Procedure for putting into circulation and operation of certain medical devices, in vitro diagnostic medical devices and active implantable medical devices, in respect of which the requirements of technical regulations are not fulfilled, but the use of which is necessary in the interests of health care" (9 page(s), in Ukrainian)

Description
The draft Order provides that certain medical devices, in vitro diagnostic devices and active implantable medical devices, in respect of which the requirements of technical regulations are not fulfilled, but the use of which is necessary in the interests of health care, may be put into circulation and operation without right of their sale in cases: - participation in international technical assistance programs; - emergency situation; - individual use and/or exploitation by individuals for the purpose of preserving their life and health; - medical support (medical application) of military servicemen and persons in the rank and file and commanding officers who execute tasks during the fulfilment the activity to ensure national security and defence during the military activities, emergency state, special period; - medical care for units of the armed forces of other states, which are admitted to the territory of Ukraine in accordance with the legislation; - humanitarian aid.

Notifying member: Ukraine

Notification: G/TBT/N/UKR/167

Objective tag
Protection of human health or safety

Documents

• 20_4485_00_x.pdf
• 20_4485_01_x.pdf

Agency responsible
Ministry of Health of Ukraine

Timing:

• Submission: 24/07/2020
• Reception: 24/07/2020
• Distribution: 24/07/2020
• Final date for comments: 22/09/2020
• Proposed date of adoption: N/A