FAQ
The word “dismissed” may appear during some process request from ANVISA, so it is important to know what the term means so that you have the tools to act appropriately, in order to gain registration with the regulatory agency.
When a request is dismissed it means that it has been denied. Therefore, you will not be able to finalize your order because some problem prevented it from continuing. The reasons for the rejection can vary greatly, depending on the type of request or the proposed action.
Lack of proof of safety and efficacy requirements in accordance with RDC No 546/21.
Health products must be designed and manufactured in such a way that its use does not compromise the clinical status and safety of patients, nor the safety and health of operators or - where applicable, other people, when used under the conditions and purposes provided.
The existing possible risks must be acceptable in relation to the benefit provided to the patient and must be reduced to a degree compatible with the protection of health and safety of people.
Failure to comply with RDC No 185/01 due to the absence of document required by current regulations (free trade certificate applicable to all models object of the petition)
RDC No 185/01, replaced by RDC 751/22, establishes that, for imported medical products, it must be presented for registration purposes, proof of registration or free trade certificate or equivalent document, granted by the competent authority of countries where the medical product is manufactured or commercialized.
It should be observed whether the document was prepared by the competent authority of countries where the medical product is marketed or manufactured, as recommended by the current resolution. Thus, not having been issued by the competent sanitary authority, the document does not meet the criteria established by the same.
We emphasize that the document must be submitted to Hague Apostille or Consularized at the Brazilian Embassy in the country of origin and, if the document is not fully written in Portuguese, Spanish or English, it must be accompanied by a sworn translation into Portuguese.
A copy containing the apostille or consular legalization of the following documents indicated in Part 3 of Technical Regulation of the RDC No 185/01, mandatory for the purposes of registration of imported medical products, was not presented: proof of registration or free trade certificate or document equivalent; and manufacturer’s declaration.
The Manufacturer’s Declaration is the document by which the Legal Manufacturer expressly authorizes the registration holder company to represent and commercialize itsr products in Brazil, in addition to declaring that it knows and meets the requirements of Good Manufacturing Practices for Health Products established in the RDC No 665/22, or regulation that replaces it. This statement must:
- Be presented in Portuguese, English or Spanish or, in case of a different language, be accompanied by a sworn translation into Portuguese;
- Be within the validity of 2 (two) years from the date of issue;
- Be signed by the responsible designated by the legal manufacturer and submitted to the Hague Apostille or Consularized in a Brazilian Consular Entity of the manufacturer’s place of origin.
Did not comply with Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA, not presenting the documents digitally signed by the Legal and Technical Officers in accordance with the company’s AFE.
In 2022, ANVISA determined through the Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA that the signatures of the Legal and Technical Responsible for all submitted documents should be replaced by the Digital Certificate in the ICP-Brasil standard, in order to guarantee the integrity and authenticity of the documents object of the submissions. To ensure that the signatures are duly valid, we recommend that the documents have their signatures validated on the website http://validar.iti.gov.br, which is the official validator of the Brazilian Government. This is the only way to ensure that summary rejections due to signature errors will be avoided.
On the other hand, there are some cases where we can have a rejection for the same reason, with a valid signature on iti, but that was signed by someone else, other than the RT or the current legal representative. This can occur when the AFE is not yet up to date, and the Technical Representative has changed recently.
