The launch was set for next month’s trade show. The distributor had already ordered stock, and the sales team had already presented the product to key customers. Then the news arrives: ANVISA has rejected the application. The first reaction, almost always, is to try to fix it the same day.
Short answer: a rejection (indeferimento) is not the end of your product in Brazil. In general there are two paths: appeal the decision, when the reason can be contested, or file a new application that corrects what led to the refusal. Which one makes sense depends on the reason written in ANVISA’s opinion. And the deadline to appeal is 30 days from the official notice.
What does it mean when ANVISA rejects a product?
It means ANVISA reviewed the registration or notification application and concluded that, as submitted, it cannot be approved. The decision is published and comes with a reason. That reason is the most important information you have right now.
The reasons usually fall into two broad groups:
- Process issues: a technical requirement (exigência) that was not answered in time, missing documents, information that does not match across documents. ANVISA’s rule on applications provides for rejection when a requirement is not met, and also when documents required at filing are missing. In that second case, the application can be rejected without any requirement being issued.
- Substantive technical issues: the evidence submitted does not support what is claimed about the product, for example on safety, performance or classification.
The difference matters, because the way out is different in each case.
Is this you? Have you read the whole opinion, or only the conclusion? Can you say, in one sentence, why the application was refused? Has someone in the company already suggested “just file again” before understanding the reason?
Can an ANVISA rejection be reversed?
In many cases, yes. There are two main paths:
| Administrative appeal | New application | |
|---|---|---|
| When it usually makes sense | The reason can be contested: there was an error of interpretation, a document was not considered, the requirement was unclear | The reason is real and must be corrected in the dossier |
| What you submit | Technical and legal arguments against the decision | A new application, with the gaps corrected |
| Watch out for | 30 days from the official notice. New documents are accepted only in limited situations | A new application with the same gaps tends to get the same result |
Under RDC 266/2019, the appeal goes first to the area that made the decision, which has 5 days to reconsider. If it does not, the appeal moves to the General Office of Appeals (Gerência-Geral de Recursos) and, as a last instance, to the Collegiate Board. The rule provides for a decision at each instance within 90 days, extendable once for the same period.
One detail weighs heavily on this choice: in an appeal, the rule only admits new documents in specific situations, such as a fact that arose after the decision. An appeal is not the place to complete the dossier. In Sobel’s view, the choice between appealing and filing again is the most important decision in the whole process. It depends on the reason, on the strength of the evidence you already have and on how long the business can wait. That is why it is made after reading the opinion, never before.
What is the deadline to appeal?
For decisions resulting from technical review, such as the rejection of a registration or a notification, RDC 266/2019 sets 30 days from the official notice. The count starts on the first business day after the notice and runs continuously, weekends and holidays included. If the last day falls on a day without office hours, the deadline moves to the next business day. The point that leaves no room for doubt: an appeal filed late is not reviewed. ANVISA does not hear it, without looking at the arguments. In such cases the company loses the chance to challenge the decision, even if it was right.
So the first practical step is to note the date of the notice and mark the last day of the deadline. Only then comes the discussion on the merits.
What to do in the first 48 hours
- Do not file anything in a hurry. No appeal and no new application before you understand the reason.
- Keep the complete opinion and the process number. No cuts, no summaries.
- Note the date the company was notified of the decision and calculate the appeal deadline.
- Gather what was filed: the dossier exactly as submitted and the communications with ANVISA.
- Decide who decides. A company in crisis needs one person with the authority to choose the path quickly.
Mistakes that make a rejection worse
- Responding without understanding the real reason. The reason written in the conclusion is sometimes the consequence, not the cause.
- Filing again with the same gaps. This can lead to a second rejection and more months of waiting.
- Letting the appeal deadline pass while the team debates internally.
- Changing strategy halfway. Starting an appeal and dropping it for a new application, without a plan, usually costs time on both.
If the rejection came from a technical requirement that was not answered well, also read the guide on technical requirements: it shows how to keep it from happening again in the next application.
How Sobel can help
In the initial assessment, a specialist in your segment reads the opinion and explains, in plain language, what ANVISA actually pointed out. You get the possible paths, the risks of each and a plan with deadlines, before deciding anything. We work with medical devices, IVD and cosmetics, including when the first application was filed by the company itself or by another consultancy.
Send your ANVISA opinion for an initial assessment. We reply within 1 business day. →
Frequently asked questions
Can an ANVISA rejection be reversed? In many cases, yes, through an administrative appeal or a new application that corrects the reason for the refusal. The right path depends on what the opinion says.
What is the difference between an appeal and a new application? In an appeal, the company challenges the decision with technical and legal arguments. In a new application, it accepts the reason and submits a corrected dossier. The appeal has a 30-day deadline and accepts new documents only in limited cases; the new application requires the gaps to have been truly resolved.
What happens if I miss the appeal deadline? A late appeal is not reviewed. It may still be possible to file a new application, but the chance to challenge the earlier decision is lost.
Does Sobel guarantee approval? No. The decision belongs to ANVISA. What we offer is a clear diagnosis, a plan and a technically sound response.
The registration was not filed by Sobel. Can you still help? Yes. Many cases come to us after an application filed by the company itself or by another consultancy.
Official sources
- RDC No. 266/2019, administrative appeals at ANVISA (text on AnvisaLegis, in Portuguese)
- RDC No. 204/2005, applications, technical requirements and rejection (consolidated text on AnvisaLegis, in Portuguese)
For information only. This does not replace an assessment of your case.
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Written by
Maik Endler
Mechanical engineer trained in Germany and former BSI auditor (Notified Body). Founder and CEO of Sobel, he leads regulatory strategy for medical devices, IVDs and cosmetics in Brazil, Europe, the UK, the US and Canada.
