Brazil: Interpretation of RDC 185

[pittmatj]

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?

 

[Marcelo]

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]

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]

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]

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]

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.

 

[tibon74]

thank you !