The dossier took months to prepare. The team gathered the manufacturer’s documents, translated, reviewed and filed. Weeks later, the application came back with a finding about a document everyone was sure was there. The question at the next meeting was simple, and no one could answer it: “what exactly was wrong?”
Short answer: most dossiers that stall do not have a serious error, but formal or consistency gaps: a mandatory document missing at filing, versions that do not match, information that changes from one document to another. Some of these gaps lead to a technical requirement. Others, such as a document required at filing being missing, can lead straight to rejection.
Why does documentation make such a difference?
Because ANVISA reviews what is in the file, and only that. Under RDC 204/2005, a technical requirement serves to ask for information and clarification on the documentation submitted. When a required document was not in the filing, including proof of the fee when it is due, the rule does not provide for a requirement: insufficient documentation leads to rejection.
In practice, this means the filing is the most important moment of the dossier. What does not go in there rarely gets a second chance in the same application.
Is this you? Before filing, did someone check the dossier against the official list of documents for your type of application? Are the manufacturer’s documents in their latest versions, and the same across the whole dossier? Do the product name, models and presentations appear the same in every document?
Which errors appear most often?
In Sobel’s experience, they repeat in five families:
| Error family | How it usually shows up |
|---|---|
| Missing document | A mandatory item for the application type was not included in the filing, or the fee was not proven |
| Inconsistency between documents | Name, models, codes, presentations or intended use change from one document to another |
| Outdated version | Manufacturer certificates, reports or declarations expired or replaced by newer versions |
| Labeling and instructions for use | Texts that do not follow the segment’s labeling rules or do not match the rest of the dossier |
| Evidence that does not support the claim | The document exists but does not prove what the application says about safety, performance or classification |
The first three are formal errors and, when well identified, are usually the fastest to fix. The last two require technical knowledge of the product and of the segment’s rules.
How to keep the dossier from coming back
The review that works is not reading each document on its own. It is checking the dossier as a whole, against the segment’s rules and against itself.
- Check the official list of documents for the application type before filing.
- Cross-check the key information (name, models, codes, intended use) in every document.
- Check dates and versions of everything that comes from the manufacturer.
- Read the labeling together with the dossier, not as a separate piece.
- For each important claim, ask where the proof is.
If the dossier has already come back with a technical requirement, the way to answer is in the guide on technical requirements. If the application was rejected, start with the guide on rejection.
How Sobel can help
In the initial assessment, we look at your dossier and ANVISA’s finding and tell you what must be corrected, what can be reused and what the shortest path from here is. We work with medical devices, IVD and cosmetics, including dossiers prepared by the company itself or by another consultancy.
Send the dossier and ANVISA’s notice for an initial assessment. We reply within 1 business day. →
Frequently asked questions
Does a missing document always lead to a technical requirement? No. Under RDC 204/2005, applications filed without the required documentation are not eligible for a requirement, and insufficient documentation leads to rejection.
Can I complete the dossier after filing? The rule provides for an addendum (aditamento), a supplement not formally requested that only improves the understanding of the file. It does not replace a mandatory document that was missing at filing.
What is the most common error? In our experience, inconsistency between documents: information that changes from one document to another. It is easy to fix and hard to see from the inside.
Do you review the dossier before filing? Yes. A review before filing is usually when it saves the most time.
Official sources
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.
