SBS - The Best Value in QMS software

IVD Registration - Use of Prospective Study Data

Mallappa

Involved In Discussions
#1
Hello all,

It would be very helpful if you could address below query regarding the regulatory aspects of IVD device registration in South Africa, Kenya and Tanzania.

Q1. Would it be possible to use prospective study data for in-country registration of an IVD? If yes, can you please let us know how to proceed with the registration of IVD?

Product: IVD, class D
 
Elsmar Forum Sponsor

Mallappa

Involved In Discussions
#2
Hello everyone,

Need your kind help for the below query.

Product: IVD, class D
Indication: used for the detection of TB.
Regulatory status: CE marking under process.

Q1. Would it be possible to use prospective study data - performance evaluation data for the registration of IVD in Tanzanai? If yes, can you please let me know how to proceed with the registration of IVD?
 
Thread starter Similar threads Forum Replies Date
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
F EU IVD Registration - Spain / Italy / France / Germany etc EU Medical Device Regulations 7
F Automated Platform (IVD) Classification/Registration (New to RA) EU Medical Device Regulations 3
A Brazil IVD Registration Fees Other Medical Device Regulations World-Wide 3
D Global market registration requirements for IVD's Other Medical Device and Orthopedic Related Topics 2
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
M IVD (in vitro diagnostic) Registration in Argentina Registrars and Notified Bodies 1
M Argentina IVD Registration Requirements Other Medical Device Regulations World-Wide 2
E IVD Diagnostic Kit Product Registration in Turkey - IVD Diagnostic Kits EU Medical Device Regulations 1
W IVD Medical Device Registration in Indonesia Other Medical Device Regulations World-Wide 2
R IVD Registration requirements in Russia Other Medical Device Regulations World-Wide 1
E IVD Medical Device Product Registration in Myanmar Other Medical Device Regulations World-Wide 3
E IVD Medical Device Product Registration in Indonesia Other Medical Device Regulations World-Wide 2
C 2012 Registration Tax for Medical Devices and IVD in France EU Medical Device Regulations 0
S IVD Device Registration in France by our local AR EU Medical Device Regulations 5
B IVD ANVISA Registration Process in Brazil and Registration Change Other Medical Device Regulations World-Wide 11
P IVD registration requirements in Middle East and African countries Other Medical Device Regulations World-Wide 1
D UAE IVD Registration (Professional Use Only, Non-A, Non-B of EU Regulation) Other Medical Device Regulations World-Wide 7
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
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
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
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
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10
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 11
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

Similar threads

Top Bottom