Rejection · technical requirement · stalled review
Has your product been rejected or stalled at ANVISA?
In most cases there is a way forward. We read ANVISA's opinion, explain what it actually asked for and build the response plan with you, before the deadline runs out.
Medical devices · IVD · Cosmetics · ISO 9001 certified in Brazil · Led by a former Notified Body auditor
To start today
What to send us
- ANVISA's opinion, notice or technical requirement
- The process number
- What was filed (dossier or application)
- The deadline stated in the document, if any
First reply within 1 business day. If we work together, the whole process runs in the Sobel Client Workspace, with restricted access.
What is your case?
Each situation has a different path
Choose what happened to your application.
01 · Rejection
The application was rejected
ANVISA refused the registration or notification and explained the reason in its opinion. The reason defines the path: sometimes it is a document gap, sometimes a substantive technical question.
Possible paths
- Administrative appeal, when the reason can be contested
- New application, correcting what led to the rejection
- Appeal deadline: 30 days from the official notice
What to do now
- Do not file anything in a hurry
- Keep the complete opinion and the process number
- Send it for the initial assessment
02 · Technical requirement
ANVISA issued a technical requirement
The application is under review, but ANVISA asked for documents, tests or clarification. An incomplete answer is one of the most common causes of rejection.
Possible paths
- Answer item by item, with evidence for each one
- Submit a justification when an item is not warranted
- Deadline: 120 days from receipt, with no extension
What to do now
- Check the deadline stated in the requirement
- List what you already have and what is missing
- Send the requirement for the initial assessment
03 · Slow review
The application has been stalled for months
The application was filed, but there is no decision and no requirement. Part of the wait is normal in ANVISA's queue; part may point to a problem in the application itself.
Possible paths
- Check the status and the queue of the application
- Check whether a requirement was missed
- Assess whether a priority request applies
What to do now
- Note the filing date and the process number
- Gather the communications received so far
- Send it for the initial assessment
04 · Documentation
ANVISA pointed out gaps in the dossier
A missing document, a wrong version, information that does not match or labeling out of standard. Depending on the gap, ANVISA issues a technical requirement or rejects the application. Formal gaps, when well identified, are usually the fastest to fix.
Possible paths
- Review of the dossier against the applicable rules
- Correction and new submission in ANVISA's format
- Labeling and instructions for use adjusted in Portuguese
What to do now
- Keep the dossier exactly as it was submitted
- Keep ANVISA's notice
- Send it for the initial assessment
Initial assessment
What you get first
- A reading of the opinion by a specialist in your segment
- What ANVISA actually asked for, in plain language
- The possible paths, with the risks of each
- A response plan with deadlines
- The effort and investment before you start
- One contact person from start to finish
How it works
From the opinion to the response
You follow every step, document and deadline in the Sobel Client Workspace.
- 01You send the opinionYou
- 02Reading and diagnosisSobel
- 03Plan and proposalSobel and you
- 04Response, appeal or new applicationSobel
- 05Follow-up until the decisionSobel
Before you answer
Haste without a diagnosis costs dearly
An incomplete answer or a new application with the same gaps can lead to a second rejection and more months of waiting.
What usually makes it worse
- Answering without understanding the real reason
- Filing again with the same gaps
- Letting the deadline run out
- Changing strategy halfway through
What helps solve it
- The complete opinion, uncut
- The dossier as it was submitted
- The history of communication with ANVISA
- One person in the company who can decide quickly
Frequently asked questions
Questions from companies with a stalled application
Direct answers on deadlines, paths and how we work.
Send your question →Can an ANVISA rejection be reversed?
In many cases, yes: through an appeal or a new application that corrects what led to the refusal. The right path depends on the reason, so we start by reading the opinion.
What is the deadline to respond?
To appeal a rejection, 30 days from the official notice (RDC 266/2019). To answer a technical requirement, 120 days from receipt, with no extension, or 30 days for import applications (RDC 204/2005). The deadline for your case is usually stated in ANVISA's document itself.
Does Sobel guarantee approval?
No. The decision belongs to ANVISA. What we guarantee is a clear diagnosis, a plan and a technically sound response.
The registration was not filed by Sobel. Can you help?
Yes. Many cases come to us after a first application filed by the company itself or by another consultancy.
Do you cover medical devices, IVD and cosmetics?
Yes, all three segments, with specialists in each area.
Guides for each situation
Understand your case in detail
- 01Product rejected by ANVISA: what now?ANVISA refused the application
- 02ANVISA technical requirement: how to answer without triggering a rejectionANVISA asked for more information
- 03Slow ANVISA review: what is normal and what signals a problemThe application is not moving
- 04The dossier errors that stall ANVISA applications mostANVISA pointed out gaps in the dossier
Initial assessment
Send the opinion. We reply within 1 business day.
Your documents are treated confidentially and used only to assess your case.
