Passarini Blog
What is GMP?
What is GMP? GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to [...]
Systems Validation
Systems Validation With the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company. The counterpoint to [...]
Hospitalar Fair 2019
Hospitalar Fairs 2019 CONFIRMED PRESENCE! Passarini Regulatory Affairs confirms its presence as an exhibitor at the 26th edition of the Hospitalar fair, which will take place from May 21 to 24, at Expo Center Norte in São Paulo / SP. During the event you can [...]
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, [...]
