Anvisa approves regulations for biosimilars
New standard eases requirements and simplifies product development, promoting a transparent regulatory environment.
Protocole the Import License after NCM reclassification
Anvisa updates procedures for licensing imports, providing new guidelines for cases of NCM reclassification.
Report approved to revise regulations on imported goods
The Board of Directors has approved the Regulatory Impact Report to revise the regulations on imported goods.
SP approves cannabidiol and tetrahydrocannabinol protocol
Resolution SS 107/05/24 directs doctors to prescribe cannabidiol and tetrahydrocannabinol for specific syndromes.
Anvisa to use external analysis to register medical devices
The measure speeds up the evaluation of products already approved by foreign authorities, reinforcing regulatory confidence.
Decree-Law implements EU regulation on medical devices
A new regulation implements EU guidelines for medical devices, setting standards for operators and market monitoring.
Anvisa prioritizes registration of dengue devices
Anvisa has decided to prioritize registration for dengue diagnosis in order to guarantee an agile and effective response to the epidemic.
Anvisa extends the validity period of the Good Practices Certificate
Anvisa extends the duration of the Good Practices Certificate to 4 years, applying to companies under the MDSAP.
Infarmed approves marketing of three cannabis products
Infarmed has approved three authorizations to place cannabis-based preparations on the market for medicinal purposes.
Anvisa joins the OAS Program – Full integration
Anvisa approved a joint ordinance with the Brazilian Federal Revenue Service, allowing it to participate in the Integrated AEO Program.