IVD (in vitro diagnostic) Registration in Argentina

M

missjenny

Hello,

We are looking to register our IVD in Argentina, which requires either a local distributor or a local consulting company to be a license holder. As we do not have a distributor yet, we would like to register through a competent consulting company with loads of experience with IVDs.

It would be great if you could recommend any that you have worked with or heard of.

Thank you.

Stephen
 
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 10
Q RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences EU Medical Device Regulations 11
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
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
sagai In Vitro Scanner Device (IVD) FDA Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Data Analysis Software classified as MDSW IVD? EU Medical Device Regulations 3
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
T IVD Self-Test Notified Body Conformity Assessment Process EU Medical Device Regulations 0
T Clinical Study Design for IVD Self-Test (lay user) Products UK Medical Device Regulations 0
M Multiple DMRs for IVD Medical Device and FDA Regulations and Standards News 0
A CE IVD Mark - Emission certifications for unexpensive product CE Marking (Conformité Européene) / CB Scheme 1
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
M IVD Device Design Change Medical Device and FDA Regulations and Standards News 2
BusyBee IVD relabeling UK Medical Device Regulations 2
R Selling same device as IVD and RUO US Medical Device Regulations 8
R Selling same device as IVD and RUO EU Medical Device Regulations 1
C South Korea - MFDS registration for a Chinese IVD factory Other Medical Device Regulations World-Wide 4
K IVD Usability IEC 62366 - Medical Device Usability Engineering 4
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
R RUO and IVD Medical Device and FDA Regulations and Standards News 1
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
M Labeling IVD Class III Medical Device and FDA Regulations and Standards News 0
R IVD Label Change China Medical Device Regulations 1
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D IVD Accuracy and Precision Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 1
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 4
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
S CE Marking components within IVD CE Marking (Conformité Européene) / CB Scheme 0
B IVD - GSPR checklist Other Medical Device Related Standards 0
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
T CE-IVD mark on packaging EU Medical Device Regulations 1
A Is computing Hardware part of the IVD CE Marking (Conformité Européene) / CB Scheme 3
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2

Similar threads

Top Bottom