Turkey Product Barcoding Requirements

C

chloep17

#1
Dear All,

We are a UK Medical Device Manufacturer or Class IIa and III products looking to get help from anyone with experience with selling into Turkey. We currently have one distributor and are hoping to register our products with a second distributor. Unfortunately we have been told that we must have separate barcodes for each distributor.

Does anyone have any experience with multiple distributors in Turkey and the barcode requirements for registration?

Any help would be greatly appreciated.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Dear All,

We are a UK Medical Device Manufacturer or Class IIa and III products looking to get help from anyone with experience with selling into Turkey. We currently have one distributor and are hoping to register our products with a second distributor. Unfortunately we have been told that we must have separate barcodes for each distributor.

Does anyone have any experience with multiple distributors in Turkey and the barcode requirements for registration?

Any help would be greatly appreciated.
A unique product number is used in the National Databank. Read attachments and look into gs1 for more information about barcode requirements.
Somebody is mistaken. There will be one barcode for one product.
If you are having the same product branded as xxxxxxxxx for a distributor xxx and as yyyyyyyyy for an other distributor yyy, the bar codes will be different, since they are two different products.
 

Attachments

Last edited:
B

BigManP

#3
Hi, this thread may be a little old, but we are just getting into distribution in Turkey and I have some questions. Is it possible to show the barcode in 2D Datamatrix format? Also, when comparing to the FDA requirements for UDI, Turkey is only interested in the Product Identifier portion of the code, right? Meaning, just the static code and not the expiration date/lot number portion.

Thanks a lot for the guidance!

Paul
 
Thread starter Similar threads Forum Replies Date
E IVD Diagnostic Kit Product Registration in Turkey - IVD Diagnostic Kits EU Medical Device Regulations 1
J Product Labeling and IFU Language requirements for Turkey Other Medical Device Regulations World-Wide 6
M EU Representative needed for Turkey? EU Medical Device Regulations 4
L Registration of an Imported Medical Drug in Turkey Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
ScottK Exporting a medical device to Turkey Other Medical Device Regulations World-Wide 2
E TURKEY: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 2
X In Vitro Diagnostic Medical Device in Turkey Registration Other Medical Device Regulations World-Wide 4
C Apostille of French Commercial Documents for the Republic of Turkey EU Medical Device Regulations 5
J European Laboratories which can do IEC/EN 60601-2-50 Testing? (Close to Turkey) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q ISO 9000 Conference Istanbul-Turkey - Looking for Speakers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Selling Directly to Physicians in Turkey EU Medical Device Regulations 4
C Medical Device Registration in Turkey EU Medical Device Regulations 41
S MDDI article on UAE, Saudi, Belarus, Ukraine, Turkey, Russia Regulations Other Medical Device Regulations World-Wide 0
J0anne GMDN (Global Medical Device Nomenclature) Australia, Japan, Turkey, Brazil Other Medical Device Regulations World-Wide 3
G What is the proper Thanks Giving turkey sampling size? Coffee Break and Water Cooler Discussions 9
amjadrana Importing Medical Devices with Computers as part of the device in Turkey Other ISO and International Standards and European Regulations 1
P CE Marking - Turkey & European Authorized Representative - Class IIa Medical Devices EU Medical Device Regulations 2
S RAB Approved Lead Auditor Training on AS 9001 in Asia? E.G Dubai, Turkey, China? Training - Internal, External, Online and Distance Learning 4
Marc Convection Oven Cooking - If you have one, do you like it? Cooked a turkey yet? Coffee Break and Water Cooler Discussions 17
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 8
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1

Similar threads

Top Bottom