Brazil IVD Registration Fees

QMS for Medical Device Companies
Elsmar Forum Sponsor
G

GLM12345

#3
#3
Marcelo - can you tell me what the regs are for "ammendment" to a registration in Brazil?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B IVD ANVISA Registration Process in Brazil and Registration Change Other Medical Device Regulations World-Wide 11
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
L Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil Other Medical Device Regulations World-Wide 2
P IVD Classification in Brazil and Anvisa Guidance Other Medical Device Regulations World-Wide 10
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
J Brazil Registration Holder Other Medical Device Regulations World-Wide 0
O Radio modular approval in Brazil Other Medical Device Regulations World-Wide 2
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
M Brazil forced degradation study requirements Reliability Analysis - Predictions, Testing and Standards 0
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
M Can Brazil approval be used for other countries in Latin America? Other Medical Device Regulations World-Wide 2
A Brazil: Termination of business relations with BRH – what happens to registrations? Other Medical Device Regulations World-Wide 1
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
J INMETRO process of Hypodermic Needle in Brazil Other Medical Device Regulations World-Wide 2
J Brazil GMP license work with multiple BRH? Other Medical Device Regulations World-Wide 3
J Brazil - Submitting Technical Files Other Medical Device Regulations World-Wide 2
C Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations Other Medical Device Regulations World-Wide 2
E Brazil - RDC 183 - Finished device - Definition Question Other Medical Device Regulations World-Wide 1
S Compliance to Brazil GMP requirements Other Medical Device Regulations World-Wide 12
A Brazil - New RDC 183 - CBPF (GMP) question Other Medical Device Regulations World-Wide 6
A Brazil - Import Medical Device Spare Parts - Without license Other Medical Device Regulations World-Wide 5
J MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device License Transfer in Brazil Other Medical Device Regulations World-Wide 2
T Cadastro according RDC40/2015 (Brazil) Cadastro Registration Requirements Other Medical Device Regulations World-Wide 1
E Sending disassembled medical device to Brazil to be re-assembled there 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
pittmatj Brazil - Electronic Registration with ANVISA Other Medical Device Regulations World-Wide 10
L IEC 60601-1 Amendment 1 3rd Edition and Brazil ABNT NBR IEC 60601-1:2010 IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
pittmatj Brazil: Interpretation of RDC 185 Other Medical Device Regulations World-Wide 6
pittmatj Are New Brazil Class I Medical Device Regulations Expected? Other Medical Device Regulations World-Wide 10
M US FDA "Single Audit Program" and Brazil Other Medical Device Regulations World-Wide 3
Y Local Agent and Sales Rights in countries like Brazil and Russia Other Medical Device Regulations World-Wide 2
E BRAZIL: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 3
M What is the Brazil - ABIMED Registration Process Other Medical Device Regulations World-Wide 6
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
Marc Medical Equipment Inmetro Certification Process in Brazil - Part 2 Other Medical Device Regulations World-Wide 3
M Informational Medical Device Registration Process in Brazil - Anvisa (Part 3) Other Medical Device Regulations World-Wide 133
B Providing a potential Customer with a Sample Medical Device in Brazil Other Medical Device Regulations World-Wide 1
K Would ANVISA (Brazil) inspect our new manufacturing site? Other Medical Device Regulations World-Wide 12
Y Can there be multiple Brazil Registration Holder (BRH) for same model ? Other Medical Device Regulations World-Wide 3
S Cadastre Process and Brazil Medical Device Registration Differences Other Medical Device Regulations World-Wide 7
E Brazil Medical Device Label Issues Other Medical Device Regulations World-Wide 3
J Electrical Safety Test Requirements for Brazil Other Medical Device Regulations World-Wide 10
B Brazil requirements to have translations of IFU to Portuguese certified Other Medical Device Regulations World-Wide 16
M Medical Device Registration Process in Brazil - Anvisa (Part 2) Other Medical Device Regulations World-Wide 71
AnaMariaVR2 ANVISA Strike to Delay Medical Device Reviews in Brazil Other Medical Device Regulations World-Wide 2
R Medical Device Registration in Brazil for Private Label Manufacture Other Medical Device Regulations World-Wide 6
S Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil Other Medical Device Regulations World-Wide 2
P Brazil's Registration Holder Fees Other Medical Device Regulations World-Wide 6
E Automotive: Local Content Suppliers in Morocco, Thailand, Brazil, and India Misc. Quality Assurance and Business Systems Related Topics 2

Similar threads

Top Bottom