The technical requirement arrived on a Tuesday. Twelve items, some clear, some less so. Half of the answers depend on the manufacturer abroad, who takes weeks to send any document. And the clock has already started.
Short answer: a technical requirement (exigência) is ANVISA’s request for documents, data or clarification on an application that is still under review. It is a chance to complete the application, not a refusal. But the deadline to answer is fixed and cannot be extended, and a missing or incomplete answer is one of the most common roads to rejection.
What is an ANVISA technical requirement?
It is how ANVISA asks for what it still needs to conclude the review. Under RDC 204/2005, the requirement asks for information or clarification on the documentation submitted at filing. In other words, it points to where the dossier did not convince or was not clear. If a mandatory document was missing at filing, the rule does not provide for a requirement: the application can be rejected directly.
Once the requirement is received, ANVISA’s deadline to decide is interrupted, and the time that had already passed no longer counts. The review only moves again after your answer.
What is the deadline to answer the requirement?
RDC 204/2005, as currently amended, sets 120 days that cannot be extended, counted from the confirmation of receipt of the requirement. Import-related applications have their own deadline of 30 days. Always check the deadline stated in the requirement itself.
If the answer is not submitted in time, the rule provides for rejection of the application, published in the Federal Official Gazette (DOU). In Sobel’s view, 120 days sound like a lot of time, but rarely are when the answer depends on tests, reports or a manufacturer in another time zone.
Is this you? Do you know on which day your requirement deadline ends? Does any item depend on a test or report that has not been done yet? Does the manufacturer know there is a deadline, and what it is?
Why do answers to technical requirements fail?
Rarely for lack of effort. In our experience, failures usually come from four places:
- The question was only half understood. The answer addresses what the team thought ANVISA wanted, not what it asked for.
- Evidence was missing. The answer explains but does not prove. A well-written paragraph does not replace a document.
- One item was left for later. The team answers eleven items and leaves the hardest one for last. It is not ready in time.
- The answer creates a new doubt. A new document brings information that does not match what was already in the file.
When the problem is in documents with formal errors, such as a wrong version or translation, the guide on dossier errors shows the most common ones.
How to structure a good answer
A strong answer has a recognizable structure: it addresses each item, in the order of the requirement, and for each one states what was asked, what is being submitted and where the evidence is. The reviewer should find the answer without searching. And it goes in one single submission: the rule requires the requirement to be met in full, in a single act. There is no “we will send the rest later”.
Three decisions make the difference before you start writing:
- Separate what already exists from what must be produced. Anything that needs a test or report starts on day one.
- Check whether each item is justified. The rule allows a justification instead of the requested document when the company believes the technical area’s assessment is not correct. It is a technical decision that needs solid grounds.
- Check consistency with the file. Everything in the answer must match what has already been filed.
What to do now
- Note the date of receipt and the last day of the deadline.
- List the items of the requirement and mark, for each one, what you already have and what is missing.
- Tell the manufacturer which items depend on them and the internal cut-off date.
- Set an internal delivery date well before the final deadline, to allow for review.
- If any item seems incorrect or unclear, decide early how to handle it, not in the last week.
How Sobel can help
In the initial assessment, we read the requirement with you and tell you what ANVISA actually asked for, item by item. You leave with what is already covered, what is missing, what depends on the manufacturer and a plan to deliver on time. If your application has already been rejected for an unmet requirement, the path is different, and it is in the guide on rejection.
Send the requirement for an initial assessment. We reply within 1 business day. →
Frequently asked questions
What is the deadline to answer an ANVISA technical requirement? RDC 204/2005 sets 120 days from the confirmation of receipt, with no extension. Import applications have a 30-day deadline. Always check the deadline stated in your requirement.
Can I ask for more time? No. Under the current rule, the deadline cannot be extended. That is why planning the answer starts on day one.
What happens if I do not answer? The rule provides for rejection of the application, published in the Federal Official Gazette.
Does a technical requirement mean the product will be refused? No. The requirement is the opportunity to complete the application. The risk lies in a missing or incomplete answer, or one that raises new doubts.
Can you help if we have already started answering? Yes. We can review an answer in progress before it is submitted.
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.
