We would like to share an important regulatory alert regarding the maintenance of the Inmetro certification linked to processes with Anvisa, in accordance with Inmetro Ordinance No. 384, applicable to equipment under sanitary surveillance.
We have observed cases where the Inmetro certificate remains valid with the OCP/Inmetro, but the document attached to the Anvisa process is outdated.
For example, still linked to Ordinance No. 54/2016 instead of the current Ordinance No. 384.
In such situations, Anvisa may consider the product as lacking a valid certification within the regulatory process, which may result in the expiration or cancellation of the registration/notification.
Additionally, to update the certificate with Anvisa, it is essential that the document complies with the current Normative Instruction, currently IN No. 283, including the updated versions of the technical standards applicable to the product.
We recommend periodically verifying:
- Whether the certificate attached to the Anvisa process corresponds to the valid certificate held with the OCP/Inmetro;
- Whether the certificate is updated according to the applicable Inmetro Ordinance;
- Whether the certificate complies with the current technical standards required by the applicable Normative Instruction (currently IN No. 283).
This preventive verification helps avoid regulatory risks and potential impacts on product commercialization.
If you have any questions, please contact us — we are at your disposal.