While debates related to clinical research and its legal
foundations within Turkey continues, a special regulation has been
issued pertaining to Medical Device clinical research. With the
path opened through this regulation, Turkey is foreseen to be a
continuously developing white hope market.
The 2008 dated Regulation Pertaining to Clinical
Researches, which has become subject of a lawsuit upon
objections of Turkish Medical Association ("TMA"), also
included clinical researches made with medical devices, and as the
mentioned regulation is still in effect as result of the lawsuit
process, no change with regard to the coverage of this regulation
On the other hand, the arguments set forth within the above
mentioned lawsuit forced the lawmaker to enact a law regarding
clinical researches and by way of adding an article to the
Principal Law on Health Services on April 6, 2011 the general frame
of clinical researches is drawn with a legal text. This Additional
Article 10 also covers researches made with clinical devices.
Following those developments, a special provision regarding
medical device clinical researches is included within the Medical
Device Regulation which has come into effect by being published on
the Official Gazette dated June 07, 2011; Article 15 of the
Regulation is on medical device clinical researches. This new
regulation has been issued in order to harmonise the national
regulation with the 93/42/EEC Directive, by exactly adopting the
principles within the directive. With the said article, different
regulations than all other clinical researches that are in scope of
the Regulation Pertaining to Clinical Researches are
foreseen for medical device clinical researches. In line with these
specific provisions, a requirement to inform the European Union
Commission has been introduced in cases such as refusal, cease,
suspension, significant alteration demand, and early termination of
medical device clinical researches. In such way, the medical device
researches are maintained to be monitored in an international
Issuance of new rules for medical device clinical researches,
while the Regulation Pertaining to Clinical Researches
including medical devices is still in force, may lead to problems
and the solution of these problems in practice will require proper
legal analysis to be conducted with the guidance of the
implementers. However, Turkey's willingness and objective to
attract research and development projects and to transfer know-how
and technology from developed countries is generally considered as
a moving spirit for solving such problems.
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guide to the subject matter. Specialist advice should be sought
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