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Notification process for class I products

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 [...]

Possibility of reducing FDA registration fees for medical devices

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 [...]

RDC No. 270_2019 – NOTIFICATION OF RISK CLASS I MEDICAL DEVICES

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, [...]

What are your challenges for 2019?

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 [...]

Dubai 2019

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 [...]

Events 2019

Events 2019 Speak with our consultants during the Fairs. For more information send us an e-mail: contato@passarini.com.br Passarini Regulatory Affairs  Published: 10/01/2019 Mais notícias:

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