IVD Diagnostic Kit Product Registration in Turkey - IVD Diagnostic Kits

E

esh14

#1
#1
Hi,

I would like to find out more details on the procedures needed for the registration of self-declared IVD diagnostic kits in Turkey.

What kind of legalization procedure needed for the Declaration of Conformity (DoC) and ISO certificate?
 
Paper to QMS ad
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
M IVD (in vitro diagnostic) Registration in Argentina Registrars and Notified Bodies 1
Q RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences EU Medical Device Regulations 6
P Risk Management Files for IVD (Invitro Diagnostic Reagent) Kits ISO 14971 - Medical Device Risk Management 3
L Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil Other Medical Device Regulations World-Wide 2
I IVD (in vitro diagnostic) Checklist for ISO 14971:2009 Annex H ISO 14971 - Medical Device Risk Management 3
S Pharma Code for Prescription Diagnostic Test IVD Other US Medical Device Regulations 1
W Insulation Grade for In Vitro Diagnostic (IVD) Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Comparative Study - 510(K) IVD (in vitro diagnostic) Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S IVD (in vitro diagnostic) Regulations in Srilanka Other Medical Device Regulations World-Wide 10
G IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues EU Medical Device Regulations 3
L Canadian Medical Device and IVD (In Vitro Diagnostic) Requirements US Food and Drug Administration (FDA) 3
bio_subbu USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Regulations for importing an IVD diagnostic test in India Other Medical Device Regulations World-Wide 16
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
G CE marking of MD and IVD set EU Medical Device Regulations 3
D List A IVD - Change to material supplier EU Medical Device Regulations 3
J IVD instrument as an accessory EU Medical Device Regulations 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J IVD CE transfer to another manufacturer EU Medical Device Regulations 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
M EU IVD Risk Determination of sample collection EU Medical Device Regulations 0
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
D RUOs in IVD products Other Medical Device and Orthopedic Related Topics 2
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
I IVD prototypes in EU market ISO 13485:2016 - Medical Device Quality Management Systems 2
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M IVD - Generating clinical data for IVD’s in the EU EU Medical Device Regulations 2
K Validation of coating plate (IVD) CE Marking (Conformité Européene) / CB Scheme 3
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
T MDD and IVD comparison Other Medical Device Regulations World-Wide 2
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom