The Myth of the “Easy” Process
In the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that “it seems easy, but it’s not!”. This simplistic view hides an alarming statistic that exposes a systemic failure in companies’ preparation: most denials executed by ANVISA occur precisely for products in these lower-risk classes.
Ignoring the hidden complexity of the Notification regime is a high-cost gamble. This article will demystify the process, reveal the technical requirements that often go unnoticed, and show why trying to navigate this scenario without specialized help can lead to a great loss of time and money.
Understanding ANVISA’s Risk Classification
Created by Law nº 9.782/1999, the National Health Surveillance Agency (ANVISA) has the institutional purpose of promoting the protection of the population’s health. To fulfill this mission within the scope of medical devices, it establishes a control system based on the potential risk a product may offer to the patient or operator.
As defined in Art. 5º of RDC nº 751/2022, devices are classified into four risk classes:
Based on this classification, RDC 751/2022 establishes two main control regimes in its Articles 6º and 7º:
▪️ Notification: Applicable to Class I and II devices.
▪️ Registration: Required for Class III and IV devices.
It is precisely the term “Notification” that generates the false sense of simplicity and leads many companies to underestimate the complexity of the process. This underestimation stems from a fundamental lack of knowledge about the documentation required behind the scenes of the Notification process.
Company Registration and Prior Compliance: The Shortest Path to ANVISA
The first and most fundamental step to enable the sale of your product in the Brazilian market and gain access to ANVISA’s services is to ensure Company Registration and Prior Compliance.
The notification of Class I and II products, although faster (routinely processed within up to 30 days after protocol), requires the company to be legally apt to operate, demonstrating its compliance even before product submission.
Conclusion: Stop Losing Time and Money
The regulatory path for Class I and II products, although seemingly simple on the surface, is full of technical requirements that, if ignored, lead to significant losses and frustration. Attempting to save money on proper regulatory advice almost always results in higher costs, launch delays, and unnecessary business risks.
Stop losing time and money with fees and more fees, and truly seek a specialized company like Passarini Group.
Contact us so we can present our services and enable your sales in the Brazilian market, now: contato@passarini.com.br
