Exclusive electronic channel
ANVISA states that Class I/II foreign-manufacturer cadastro actions — creation, change, and invalidation — are performed exclusively in Solicita using subject code 80326; the notice explicitly includes IVDs. ANVISA.
All topics
Brazil regulatory update / Solicita 80326 / Class I-II including IVD
Brazil ANVISA Update: Class I/II Foreign-Manufacturer Cadastro Is Now Electronic
ANVISA now requires Class I/II foreign-manufacturer cadastro, including IVDs, to be filed exclusively through Solicita under subject code 80326. Class III/IV GMP-linked filing is unchanged.
Officially published by ANVISA: 14 August 2026, 16:30 Brasília time.
Direct answer
For a Class I or II device or IVD made outside Brazil, create, amend, or invalidate the foreign-manufacturer cadastro only in ANVISA Solicita under subject code 80326. For operational planning, treat this as a filing-path change and do not apply code 80326 to Class III/IV products, which remain linked to the GMP (CBPF) process. ANVISA.
Verified official change
Class III/IV boundary
The notice says this change does not affect Class III/IV products: their foreign-manufacturer cadastro remains submitted together with the GMP (CBPF) petition. ANVISA.
Ten-business-day escalation point
If ANVISA has not issued the unique foreign-manufacturer code or a rejection letter within 10 business days after submission, ANVISA directs the applicant to contact its service channel. ANVISA.
Why the code matters
The cadastro produces the unique foreign-manufacturer code, which ANVISA identifies as necessary for import-compliance filings. ANVISA.
Practical actions for China exporters
Re-map active I/II work now
For each China-made Class I/II device or IVD in preparation, have the Brazil Registration Holder confirm that the foreign-manufacturer cadastro is routed in Solicita under 80326; do not continue an older route merely because a dossier checklist still names it. ANVISA.
Separate the portfolios
Keep Class III/IV products on their GMP-linked track. A shared manufacturer across low- and higher-risk products does not make 80326 a universal filing code. ANVISA.
Make the 10-day control visible
Record submission date, Solicita protocol, unique-code receipt, and any rejection letter. Escalate through ANVISA if neither outcome is received by the tenth business day; this protects the downstream import filing from an untracked administrative delay. ANVISA.
Official ANVISA links
ANVISA — Cadastro de fabricantes internacionais de dispositivos médicos risco I e II agora é eletrônico (official notice, 2026-08-14)Continue to the Brazil country page
This update is attached to the Brazil medical-device country page, where classification, BRH, and the full market-entry route remain available.
View Brazil page