FREQUENTLY ASKED QUESTIONS

 

01- Can you apply for registration of a product on behalf of a foreign company?

No. The registration of products should always be requested on behalf of a company duly authorized in Brazil.

02- What is the difference between the processes of CADASTER and REGISTRATION of products for health?

Basically, the following differences are as follows:

CADASTER REGISTRATION
EQUIREMENT of GOOD PRACTICES CERTIFICATION by MANUFACTURER N/A MANDATORY
VALIDITY INDETERMINATE 05 YEARS
RISK CLASS I & II III & IV
EFFICIENCY AND SAFETY CHECK Generally only required for innovative products Mandatory presentation
03- Is the risk classification of health products adopted by ANVISA the same as that adopted in other countries?

No, ANVISA has specific regulations. Although some criteria are similar, there are particularities that must be followed, which vary according to the product in need of registration / cadaster.

04- Is the registration/cadaster process with ANVISA for products that already have FDA or CE MARK approval faster?

No. The fact that a product already has approval in other countries does not facilitate nor expedite approval in Brazil.

05- Does the product that has already been previously approved by ANVISA and needs to be registered again by another company have any kind of priority in the analysis?

No, ANVISA will treat it as a new process and will analyze all the documentation again. Priority of analysis is granted only in specific cases, according to the current legislation.

06- How long does ANVISA take to approve a product?

The legal deadline for process analysis is 90 days, however it may happen that a process is analyzed before or after this deadline. This period varies according to the demand of processes received by ANVISA and the type of product.

07- If a product goes through a modification does it require a new registry or can we modify the existing registry?

It is possible to modify the existing registry. The vast majority of modifications are subject to notification and approval by ANVISA, prior to implementation in Brazil.

08- When the Technical Manager is modified is it necessary to update the registries in ANVISA?

No. In this case, the company should only update the information of the Technical Manager along with the Class Council and together with COVISA (operating license) and ANVISA (electronic ordering system).

09- In cases of modification of the importer’s address (registration holder), is it necessary to update the registries in ANVISA?

No. In this case, the company should only update the address information together with COVISA (operating license) and ANVISA (electronic ordering system).

10- In cases of change of the Manufacturer’s address (NATIONAL or INTERNATIONAL), is it necessary to update the registration in ANVISA?

Yes. This change must be formalized and approved by ANVISA, before its implementation in Brazil.

11- What is the deadline to request the registration renewal?

The ratification must be formalized within at least 1 year and a maximum of 6 months before the registration expiration

12- Is it possible to group different products in the same process?

Yes, however, it is necessary to observe the requirements in the current legislation, regarding the grouping of products in family / system / set.

13- What is the deadline for compliance?

The company has 120 days to comply with ANVISA requirements. This period is counted from the date of reading of the requirement.

14- Is it possible that ANVISA issues more than one requirement per process?

Yes, it is possible, although it is usually 1 requirement per process.

15- What is the deadline for a rejected appeal protocol?

The company has 10 calendar days to file the rejected application in ANVISA. This period is counted from the date of publication of the rejected process in DOU.

16- Does ANVISA accept Certificates of Good Practices (e.g. ISO 13.485, FDA, etc.) issued by other countries that replace international inspection?

No, ANVISA has specific legislation related to Certificates of Good Practices. For this reason, ANVISA inspects the manufacturers, following the scopes of the Brazilian legislation. There is the MDASP Pilot Project, which is currently in progress.

17- If another company has already applied for the inspection of an international manufacturer and obtained the certification, can I use this same certificate for my registries or do I have to pay a new fee and have a new inspection linked to my company?

The certificate of Good Manufacturing Practices issued by ANVISA is linked to the Brazilian company requesting certification and cannot be used by another company. In the case that more than one company requires a certificate from the same manufacturer, it is necessary for each company to request and pay for its certification.

19- The product already has a Certificate of Compliance in its country of origin, is it possible to use this same certificate to apply for registration with ANVISA?

No. The compliance certification that is accepted by ANVISA must be performed in Brazil according to the standards made available by INMETRO.

20- What is the registration fee amount of ANVISA?

The ANVISA registration fee amounts depend on the size of the company and the type of the process to be registered. It is necessary to consult the legislation to discover the value applicable to each case.

21- Is it possible to transfer registries/cadasters?

Yes, it is possible; however, it is necessary to observe the requirements in the current legislation, related to the transfer of ownership. The transfer is only possible in specific cases as mergers, splits, incorporations, assignments of rights and commercial operations between companies, not being applicable in any case.