News and analysis from the regulated market.
Updates on ANVISA (Brazilian FDA), MAPA (Agriculture Ministry), trademarks, foreign trade and quality — written by Wissen's technical team for international clients who need to stay ahead of Brazilian regulation.
Brazil's NR-1 enters punitive enforcement on May 26, 2026: psychosocial risks now subject to fines
When NR-1 was updated to include psychosocial risks, companies got a transition period. That period is over.
Brazil's New Cannabis Framework: RDC 1.015/2026 expands medical access
Brazil's health regulator ANVISA restructured the medical cannabis framework with a package of four RDCs. RDC 1.015/2026, in force since May 4, is the heart of the reform.
Brazil's supplement regulation: deadline for compliance is September 2026
Less than 4 months remain for compliance with ANVISA's regulation that reshapes the Brazilian food supplement market — and those who don't adapt lose shelf space.
RDC 907/2024 — Brazil's new cosmetics regulation explained for international brands
Brazil's health authority (ANVISA) replaced a patchwork of old rules with a single, modern cosmetics regulation. International brands selling in Brazil need to know what changed.
Brazil UDI implementation: RDC 884/2024 explained for medical device manufacturers
Brazil's UDI implementation follows the same global model used by the FDA and EU — but with local nuances. Manufacturers selling devices in Brazil must adapt or face market suspension.
Brazil authorizes Cannabis Sativa cultivation for medicinal and research use
Brazil took a decisive step in medicinal Cannabis regulation: ANVISA authorized cultivation of the plant for medicinal and research purposes, closing a regulatory cycle that began in 2019.
Law 15.352/2026: Brazil's data protection authority becomes a full regulatory agency
Brazil's data protection authority got institutional teeth. Law 15.352/2026 elevates ANPD to full regulatory agency status.
Brazil's INPI 2026: AI promises to slash trademark registration from 18 months to 30 days
Brazil's National Institute of Industrial Property is undergoing the biggest modernization in its history.
ANVISA's 'New Quality Era': how Brazil is aligning with ICH and PIC/S standards
Brazil's health regulator called it the 'New Quality Era'. For anyone manufacturing regulated products, it's the biggest quality framework update in a decade.
Holder Service in Brazil: how to keep ANVISA product registrations without a Brazilian entity
For an international brand that wants to enter the Brazilian market without setting up a local entity, Holder Service is the front door — provided it's done with technical rigor.
GMP and CBPF: how to get Brazil's Good Manufacturing Practices Certificate
GMP is not a rule, it is a system. Whoever manufactures ANVISA-regulated products in Brazil must operate within it, and the CBPF is the formal evidence.
Importing regulated products into Brazil: step-by-step guide for foreign suppliers
Importing a regulated product into Brazil isn't just buying abroad and unloading at port. The flow goes through several systems — Siscomex, ANVISA, Federal Revenue — and any failure halts the cargo.
Trademark, patent, industrial design and copyright: which protection for which asset
Each form of intellectual property protects something different.
Madrid Protocol from Brazil: trademark registration in 130+ countries with a single filing
Before 2019, registering a trademark in multiple countries from Brazil was an administrative nightmare. Today, with the Madrid Protocol, a single application from Brazil can cover more than 100 countries.
Radar Siscomex registration: modalities and how to obtain it to trade with Brazil
Before closing the first import or export operation, the company must be registered in Radar.
ISO 9001: how to start the quality certification in an industrial company
A company entering a regulated market sooner or later faces the question: do you have ISO 9001?