The Product Tracking System may require Technical Files in certain cases. There needs to be some sort of predefined cycle between the manufacturer and such entities as a Notified Body and National Competent Authority (i.e., the Medicines and Medical Devices Agency of Turkey acting under the Ministry of Health) running to tell whether a product is a medical device or not. The Ministry of Health may demand for the provision of certain information and documents to assess, with absolute certainty, whether or not a given or group of products either intended for registration or already registered in the PTS possess (es) the quality and nature of a medical device. Such information and documents are compiled in the so-called Technical File meant for storage in archival folders. The manufacturers are responsible for preparing them.
SA FREQUENTLY ASKED AND SUBMITTED DOCUMENT
The Technical File is a content merely supplied on request, when doubt arises especially about the classification of a particular medical device on the Product Tracking System of the Medicines and Medical Devices Agency of Turkey, which may also be created by manufacturers at option. Judging by its general use and the frequency of uploads to the PTS, it goes without saying that every bit of information contained in the Technical File is vastly utilized, which is why, it ranks the top among most frequently asked and submitted documents. Preparing the technical file so as to include as much information and documents as possible is a procedure of key importance leading to actual identification of a given medical device product's class, and establishment of document requirements accordingly, not to mention how influential it can be on receipt of reimbursements.
HIGH SIGNIFICANCE ATTACHED TO CLINICAL EVALUATION REPORTS
The clinical evaluation report described in
Annex
X of the
Medical Device Directive 93
/42
/EEC is now
a
must have for any
technical file to be drawn and submitted
with respect to
a
medical device product. What's
more
, the regulation
mandates that
all information and documents on the effect
or action
mechanism
,
machinery and
equipment used in the
manufacture
, target
population and indications of
a
medical
device product and applicable standards
-
compliant
management system
s adopted
and employed by its
manufacturer should
be added in this context
, as well
. Another
obligation superimposed by this Directive
and naturally reflected in subsequent
issues of relevant Notices is the submission
of whole contents of the technical file to the Medicines and Medical Devices Agency of
Turkey in
a clear wording wielded in
Turkish
. Especially any error or flaw found
with Turkish translations so submitted is
prone to consequent application or process
denials owing to potential encounters of
oddities in
a given product's classification
details. Finally, the content thus drawn is to
be delivered through the EIS to conclude
the procedure
.
W e only aim for your best satisfaction !
