01
Pi reads the paste
It checks the supplied evidence against this form’s field descriptions.
Free ANVISA official form tool
Free ANVISA Medical Device Classification Form Filler
Turn pasted company and device facts into a review-ready draft of ANVISA’s official Ficha de Enquadramento V2 Word form. Keep the regulator’s original editable file instead of receiving a generic AI report.
Paste any text formatForm-specific expected JSONEditable DOCX downloadUnsupported fields stay blank
Paste the source material you already have
Use notes, an email, a product description, company details, or copied dossier content. Formatting does not matter. The agent maps reliable facts into this form’s fixed JSON contract, then a deterministic writer fills the official DOCX template.
Do not paste patient-identifying, payment-card, password, or highly confidential information.0 / 50,000
File privacy: the generated document is stored at a hard-to-guess public download URL. Anyone with that URL can access it. Do not use this free tool for patient data, passwords, trade secrets, or material you are not authorized to share.
Current official source
Ficha de Enquadramento V2
ANVISA currently lists this form for medical device classification questions.
Checked: 2026-08-12
Stored source SHA-256: 6ec211c9aeba9ab71b671e4ee54e045fa057b747ae06c6369b0e38bae8955edb
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
How it works
Agent reasoning, deterministic file writing
The agent can reason over unstructured notes without being trusted to modify the document package. The expected JSON is the handoff contract.
02
The JSON contract validates
Every one of the 34 expected keys is present; missing evidence is null.
03
The DOCX writer runs
A deterministic adapter writes accepted values into fixed locations in the stored official template.
Other free official form tools
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Paste an unstructured portfolio or product list and download the official ANVISA model-list spreadsheet populated with extracted model names.
COFEPRIS registration form filler
Paste applicant, establishment, product, and manufacturer facts and receive a preliminary filled copy of the current COFEPRIS authorizations Word form.
Prepare the supporting administration
Need the letter that accompanies this form?
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 buildersOfficial form filler FAQ
Does the AI edit the Word form directly?
No. Pi produces a validated, form-specific JSON object. A deterministic writer then places only accepted non-null values into fixed positions in the stored official Word or Excel template.
What happens when information is missing?
The field remains blank and appears in the review list. The agent is instructed not to guess identifiers, classifications, addresses, signatures, or other unsupported facts.
Is the downloaded form ready to submit?
No. It is an editable AI-prepared draft. Confirm the current official form, instructions, procedure, evidence, language, signatures, attachments, and every populated field before use.
Does this tool submit anything to the regulator?
No. It does not create an authority account, pay fees, sign, certify, or submit a filing.