Pi reads the paste
It checks the supplied evidence against this form’s field descriptions.

Prepare the device-registration fields in the Word attachment linked by COFEPRIS as FF-COFEPRIS-21. The downloaded document currently displays FF-COFEPRIS-01 internally, so the applicable procedure and identity must be confirmed before filing. Keep the regulator’s original editable file instead of receiving a generic AI report.
Use notes, an email, a product description, company details, or copied dossier content. The agent maps reliable facts into this form’s fixed JSON contract, then a deterministic writer fills the official DOCX template.
The current COFEPRIS form catalog separates the two tasks: the generic authorizations, certificates, and visits form is now FF-COFEPRIS-01 and medical device registration and renewal (registro sanitario y prórroga de dispositivos médicos) has its own dedicated FF-COFEPRIS-21. The form footer states V1.0 and publication on 14 August 2026; 04AGO2026 in the download filename is retained as a file identifier, not the publication date. This tool targets the dedicated device form.
The agent can reason over unstructured notes without being trusted to modify the document package. The expected JSON is the handoff contract.
It checks the supplied evidence against this form’s field descriptions.
Every one of the 33 expected keys is present; missing evidence is null.
A deterministic adapter writes accepted values into fixed locations in the stored official template.
Paste product and company information and receive an AI-prepared copy of ANVISA’s Class III and IV medical device petition form.
Turn pasted company and device facts into a review-ready draft of ANVISA’s official Ficha de Enquadramento V2 Word form.
Paste an unstructured portfolio or product list and download the official ANVISA model-list spreadsheet populated with extracted model names.
Use the same paste-first workflow to prepare editable cover letters, authorization or representation letters, powers of attorney, declarations, truthful statements, and Free Sale Certificate requests.
Open regulatory document buildersThis tool does not create an authority account, pay fees, sign, certify, or submit a filing. It transcribes the evidence you paste into the stored official template so your team can review and finish the draft.