The Turkish Medicine and Medical Device Institution has amended
requirements for notifying the local health authority about staff
changes for medical device sales and promotion support. Changes
also apply to where medical device sales centres can be located,
generally lifting certain restrictions acceptable locations.
The Regulation Amending the Regulation on Sale, Advertising and
Promotion of Medical Devices ("Amendment
Regulation") was published in Official Gazette number
29835 on 22 September 2016, entering into effect on the same
Notable amendments introduced by the Amendment Regulation
Sales centres which have only one
staff member for sales and promotion support must now notify the
Local Health Authority within five working days if that person is
no longer working at the centre (due to resignation, dismissal or
loss of qualifications). The deadline is 15 working days if the
relevant staffmember has died. New personnel should be assigned to
this position within one month.
Education activities for health
professionals and technical personnel working in the medical
devices department of health institutions and organizations
executed in simulation centres and cadaver study centres will no
longer be considered scientific and educational activities.
The scope of prohibited locations for
sales centres is reduced and this restriction no longer applies
Clinics and laboratory diagnosis
centres which merely provide examination and imaging services.
Hearing aid centres.
Prosthesis and orthosis centres.
Dental prosthesis laboratories.
Except for the above exemptions,
medical device sales centres cannot be opened in the buildings
(including its yard) and its extensions in which a health
institution and organization is located. The restriction on
establishing a sales centre in places zoned for healthcare which
are owned by the serving health facility has now been removed.
Please see this link for full text of the Amendment
Regulation (only available in Turkish).
Information first published in the MA | Gazette, a fortnightly legal
update newsletter produced by Moroğlu Arseven.
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