You probably have experienced frustration related to the rejection of your product application in some country. Perhaps you’re experiencing it now. Basically, if you need Brazil medical device registration, you will need ours help.
Here is how one company finally overcame multiple rejections from ANVISA Brazil.
A large manufacturer of surgical devices sought registration for three different Class IIb product families in Brazil. The manufacturer’s application was repeatedly rejected by ANVISA (Ministry of Health in Brazil) with new deficiencies each time. This led the device manufacturer to approach ANVISA with different response strategies, which only led to further rejections and confusion.
In an attempt to obtain regulatory approval in Brazil, the device manufacturer spent three months identifying and appointing an internal champion to oversee the applications. The internal champion wasted an additional two months sourcing knowledge internally on ANVISA application best practice. After much avail, the team decided to hire a local regulatory consulting company in Brazil. With the help of the consulting company, the client submitted the application to ANVISA only to have it denied three times with new deficiencies each time. Eighteen months later, the manufacturer’s products still failed to penetrate the market. After almost two years of repeated rejection, the manufacturer wanted to understand what was keeping its application from gaining ANVISA’s approval.
RegDesk’s unique, expert-sourced regulatory intelligence product helped the client understand exactly where and why their application process continuously went wrong. By learning the official and unofficial requirements from multiple leading Brazilian experts and leveraging a local network of leading experts, our client gained the most relevant insights, which also highlighted areas of consensus and dissent amongst experts. These insights were critical to the potential success of the resubmission process.
Not only did the client gain the knowledge and insights required to put together a promising application for ANVISA, but it was also assured that the information it received is valid as it was verified by in-country experts. Prior to hiring RegDesk, the client was unaware of the unofficial requirements that are crucial to Brazil’s application process. Based on the intelligence received through RegDesk, the client revised their application in record time.
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