Medical Device Certification Process of Argentina and Russia

Roland chung

Trusted Information Resource
#1
Hello all,

We are going to sell product to Argentina and Russia market. But I am new for these two regulators. Could you please share some experiences on the certification process of Argentina and Russia?

I will much appreciate your inputs.

Regards,
Roland
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
Hi Roland,

At the bottom of this page there are a couple of links to discussion threads on registration of devices in Russia.

In this thread http://elsmar.com/Forums/showthread.php?t=41256&highlight=registration+argentina you can find links to information regarding various South American countries, including Argentina. Additionally, you can take a look here at Emergos Website: http://www.emergogroup.com/resources/regulations-argentina (I am not affiliated with them) where you can find more information.

:bigwave:
 
Thread starter Similar threads Forum Replies Date
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
B Medical device manufacturer - Product certification (Small businesses) EU Medical Device Regulations 2
W Indonesia - Medical device certification / registration Other Medical Device Regulations World-Wide 3
R Is INMETRO certification suitable for medical device components? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Medical Device IDE - IEC 60601-1 Certification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
K List of Recognized product certification by country for Medical Device Various Other Specifications, Standards, and related Requirements 4
S Retrospective Medical Device Certification ISO 13485:2016 - Medical Device Quality Management Systems 1
H CMDCAS Certification and Canadian Medical Device Regulations Various Other Specifications, Standards, and related Requirements 4
M RAC Certification - R.A. Specialist in a Medical Device company Professional Certifications and Degrees 16
L Canadian Certification Required for a USA-Based Class I Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical device name in different countries EU Medical Device Regulations 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
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
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1

Similar threads

Top Bottom