Brazil - Import Medical Device Spare Parts - Without license

apuigvert

Involved In Discussions
#1
Hello all!,

I was hoping you can help me with a situation. We have a valid license for a device in Brazil. This license will end soon and we are not planning on further market this specific device in Brazil (but a succeeding model).

BUT we already sold some of the devices in Brazil and we are now wondering what will happen to the accessories/disposables which were listed on the license?

Are we still allowed to deliver those accessories/disposable to their clients who bought the main device?

Thank you very much in advance!
 
Elsmar Forum Sponsor

apuigvert

Involved In Discussions
#5
If the part is not a medical device, it's not regulated by ANVISA, so you would not need an ANVISA permit or anything to do so.
Actually, some consumables could be considered a medical device (i.e. infusion guides). If those consumables were included in the license that expired, should we submit a new license for them? Thanks!
 

Marcelo

Inactive Registered Visitor
#6
Actually, some consumables could be considered a medical device (i.e. infusion guides). If those consumables were included in the license that expired, should we submit a new license for them? Thanks!
When you say license, do you mean product registration (or cadastre in the case of Class I and II), right?

If so, you need to have valid product registrations to sell to Brazil.
 
Thread starter Similar threads Forum Replies Date
P Import of medical devices to Brazil without registration possible ? Other Medical Device Regulations World-Wide 5
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 0
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
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
A Brazil IVD Registration Fees Other Medical Device Regulations World-Wide 3
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
L Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil Other Medical Device Regulations World-Wide 2
S Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil Other Medical Device Regulations World-Wide 2
P IVD Classification in Brazil and Anvisa Guidance Other Medical Device Regulations World-Wide 10
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
R Medical Device Approval in Brazil - Understanding INMETRO and ANVISA Other Medical Device Regulations World-Wide 127
M Medical Device News INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets Other Medical Device Regulations World-Wide 7
B IVD ANVISA Registration Process in Brazil and Registration Change Other Medical Device Regulations World-Wide 11

Similar threads

Top Bottom