Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

[tibon74]

thank you !

 

[Amy Wong]

Hello Marcelo,

We are looking for some information about importing Veterinary MRI into Brazil. While searching on ANVISA?s web, we cannot find any related information about animal machines. However, from some other forum and agencies, some feedback says Veterinary medical machine should also register under ANVISA.
So, based on your professional knowledge, is there any regulation related to vet machines? import, export, distribute and sales within Brazil?
If not, do we have to other voluntary actions such as registration if we want to sale our product in Brazil?

Look forward to your reply.

Amy Wong

 

[somashekar]

• Verify that the manufacturer has established and maintains procedures to ensure the retention of components, raw materials, in-process products and returned products until inspections, tests or other specified verifications have been performed and documented [RDC ANVISA 16/2013: 5.3.3].

From the MDSAP audit model

What is the meaning of this requirement in the RDC 16. What is the manufacturer expected to have in the procedure or documented procedure ...

 

[Marcelo]

We are looking for some information about importing Veterinary MRI into Brazil. While searching on ANVISA’s web, we cannot find any related information about animal machines. However, from some other forum and agencies, some feedback says Veterinary medical machine should also register under ANVISA.
So, based on your professional knowledge, is there any regulation related to vet machines’ import, export, distribute and sales within Brazil?
If not, do we have to other voluntary actions such as registration if we want to sale our product in Brazil?

Hi, veterinary products are not regulated by ANVISA so you do not have to register the device in ANVISA. You may need to comply with MAPA (ministry of Agriculture) requirements, but I would not know which since this is not my area of expertise.

 

[Marcelo]

Quote:
• Verify that the manufacturer has established and maintains procedures to ensure the retention of components, raw materials, in-process products and returned products until inspections, tests or other specified verifications have been performed and documented [RDC ANVISA 16/2013: 5.3.3].

From the MDSAP audit model

What is the meaning of this requirement in the RDC 16. What is the manufacturer expected to have in the procedure or documented procedure ...

This is the product/components/raw materials inspection procedure.

 

[somashekar]

RDC 16 / 2.5.5. An agreement shall be documented in which the suppliers undertake to notify the manufacturer about any change in the product or service, so that the manufacturer can determine if the change affects the quality of the finished product.

Does ANVISA look for a specific signed agreement from all supplier, or if the same is captured in the PO terms and conditions, it would suffice meeting 2.5.5 requirement.

RDC 16 / 3.1.5. Records of changes to documents. Each manufacturer shall maintain records of changes to documents, including a description of the change, identification of the changed documents and the affected documents, identification of the responsible person, date of approval and date on which the change shall enter into force. A list of valid documents shall be maintained in order to identify their current status and ensure that only updated and approved documents are in use.

So ANVISA will expect to see a "Master list of documents" ? This has never been a shall requirement in the ISO or FDA ...
If the change details and approval / date is within each document, perhaps in the last page of each document, will it meet the intent of ANVISA ?

 

[Marcelo]

Quote:
RDC 16 / 2.5.5. An agreement shall be documented in which the suppliers undertake to notify the manufacturer about any change in the product or service, so that the manufacturer can determine if the change affects the quality of the finished product.
Does ANVISA look for a specific signed agreement from all supplier, or if the same is captured in the PO terms and conditions, it would suffice meeting 2.5.5 requirement.

From all suppliers.

Quote:
RDC 16 / 3.1.5. Records of changes to documents. Each manufacturer shall maintain records of changes to documents, including a description of the change, identification of the changed documents and the affected documents, identification of the responsible person, date of approval and date on which the change shall enter into force. A list of valid documents shall be maintained in order to identify their current status and ensure that only updated and approved documents are in use.
So ANVISA will expect to see a "Master list of documents" ? This has never been a shall requirement in the ISO or FDA ...
If the change details and approval / date is within each document, perhaps in the last page of each document, will it meet the intent of ANVISA ?

Nope.

 

[Marcelo]

This has never been a shall requirement in the ISO or FDA ...

And just a clarification, a list (or equivalent procedure) was a requirement in older versions of standards.

 

[tibon74]

Hi Marcelo,

If a medical device include vitamin E, is it considered as medical device or drug in Brazil?
What is its classification, class IV? Is there a specific requirements for this kind of medical device ?
thank you !

 

[Marcelo]

If a medical device include vitamin E, is it considered as medical device or drug in Brazil?
What is its classification, class IV? Is there a specific requirements for this kind of medical device ?
thank you !

It?s the same as in the EU, meaning, it depends wether the intended use is as a drug or device.

The class is based on the same rule 13 of the MDD (All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III), so if it would class IV in Brazil if he rule is applied.