Brazil: Interpretation of RDC 185

pittmatj

Involved In Discussions
#1
From Part 3 Procedures for Registration:


3. New presentations of a medical product set already registered and in intact individual packaging are hereby exempt from registration, provided that its label and instructions for use contains the information about the registration of the corresponding medical products.


Does this mean that the items in a set of medical devices registered with ANVISA can be be sold separately so long as they have the proper IFU/labelling?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
This translation is wrong, the correct translation is:

3. New presentations which consists of a set of devices which are separately registered and in intact individual packaging are hereby exempt from registration, provided that its label and instructions for use contains the information about the registration of the corresponding medical products.

It means that if your set is composed of devices which are already registered (separated), the set does not need a new registration.
 

pittmatj

Involved In Discussions
#3
I see, there's often confusion that if a registered device changes model numbers (or in this case is in included in a set) that there will be need for an amendment to the Cadastro/Registro.

It seems that a registered devices can undergo a clerical change without going through the registration or amendment process again.
 

Marcelo

Inactive Registered Visitor
#4
It seems that a registered devices can undergo a clerical change without going through the registration or amendment process again.
Yes, but depending on the modification, you have to file a change with ANVISA.
 

tibon74

Involved In Discussions
#5
Hello,

Sometimes, when an instrument (included in a set) is worn for example, the manufacturer send a new one in an unitary packaging to replace it. Should we declare that to ANVISA or this instrument is exempt from registration?
For information, individual references of the instruments appears in the registration license.

thank you!
 

Marcelo

Inactive Registered Visitor
#6
Sometimes, when an instrument (included in a set) is worn for example, the manufacturer send a new one in an unitary packaging to replace it. Should we declare that to ANVISA or this instrument is exempt from registration?
For information, individual references of the instruments appears in the registration license.
If it already has it?s own registration, as I mentioned before, you don?t need to declared anything.
 
Thread starter Similar threads Forum Replies Date
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
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 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