FREQUENTLY ASKED QUESTIONS
No. The registration of products should always be requested on behalf of a company duly authorized in Brazil.
Basically, the following differences are as follows:
|EQUIREMENT of GOOD PRACTICES CERTIFICATION by MANUFACTURER||N/A||MANDATORY|
|RISK CLASS||I & II||III & IV|
|EFFICIENCY AND SAFETY CHECK||Generally only required for innovative products||Mandatory presentation|
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.
No. The fact that a product already has approval in other countries does not facilitate nor expedite approval in Brazil.
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.
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.
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.
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).
No. In this case, the company should only update the address information together with COVISA (operating license) and ANVISA (electronic ordering system).
Yes. This change must be formalized and approved by ANVISA, before its implementation in Brazil.
The ratification must be formalized within at least 1 year and a maximum of 6 months before the registration expiration
Yes, however, it is necessary to observe the requirements in the current legislation, regarding the grouping of products in family / system / set.
The company has 120 days to comply with ANVISA requirements. This period is counted from the date of reading of the requirement.
Yes, it is possible, although it is usually 1 requirement per process.
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.
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.
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.
The validity period is 2 years.
No. The compliance certification that is accepted by ANVISA must be performed in Brazil according to the standards made available by INMETRO.
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.
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.