Guidance of the Notification process for class I products Anvisa published on Tuesday (2/4) a document with guidelines, in portuguese, for the regulated sector about the new standard of notification process of the medical devices and IVD class of risk I, regulated by the RDC 270/2019. The document contains: Clarification [...]
Possibility of reducing FDA registration fees for medical devices Like ANVISA, FDA allows different medical device registration fee values to be applied according to the company's annual revenue. This benefit is granted to both American and foreign companies. Medical device manufacturers whose annual billing is less than $ 100 million [...]
RDC No. 270_2019 - NOTIFICATION OF RISK CLASS I MEDICAL DEVICES On February 28th, a new resolution was publicated. The RDC No. 270/2019. The resolution provides for migration from the cadastre to the notification for medical devices of class I. This Resolution applies to Equipment, Health Use Materials and In [...]
Start 2019 with an exclusive gift from Passarini Regulatory Affairs Are your goals and challenges for 2019 already set? How was it for you and your company to plan the year? Passarini Regulatory Affairs is here to offer you the best solutions in the healthcare market, for Brazil, LATAM, United [...]
Arab Health 2019 Check out the videos below for news from Dubai. Choose the language of the video and click the link below: Passarini Regulatory Affairs has been working for more than 10 years with ANVISA and has highly knowledgeable professionals with vast experience in product [...]
Events 2019 Speak with our consultants during the Fairs. For more information send us an e-mail: [email protected] Passarini Regulatory Affairs Published: 10/01/2019 Mais notícias:
Health Product Labeling Information There has been increasing demand for questions about the correct interpretation of the label content of single-use products available on the market. For a better understanding about it, ANVISA published on October 3, 2013, a technical note clarifying and detailing the subject. Access the complete technical [...]
August in Double Check below the promotion that will stir your month of August. Get 02 ANVISA REGISTRATION PROCESSES and pay only one. Send you requeriments to [email protected] and get your quotation. Rules: The second application must be done until December 14th, 2018 and must have the same characteristics (Cadastre [...]
Hospitalar 2018 Passarini confirms lectures at the Hospitalar Fair: More news:
Brazil’s ANVISA Streamlines Medical Device Importation Processes A new ANVISA resolution has simplified medical device importation requirements for Brazil. Imported devices no longer have to undergo inspections at Brazilian points of entry. Additional changes to simplify ANVISA importation requirements are anticipated in the near future. Among other changes, ANVISA Resolution [...]
