Registering a medical device in Colombia is not just a technical step — it is also a legal process. Since 2024, in addition to meeting all the technical and legal requirements for your registration, you must also comply with INVIMA’s semantic reporting of your product’s UDI codes.
In this article, we explain what legal services for INVIMA registration really involve, why your company needs them, and how Nieto Lawyers has helped over 40 companies comply fully with the law — avoiding costly surprises.
Why Do You Need Legal Services for INVIMA Registration?
Because it’s not just about filling out a form. Registering a device with INVIMA involves:
- Interpreting complex health regulations.
- Presenting valid, coherent technical documentation.
- Meeting requirements that change with every update (such as the semantic standard in force since 2023).
- Preventing penalties due to errors or inconsistencies.
- Defending your company legally if INVIMA issues requirements or rejections.
- Preventing product clearance rejections by VUCE during importation.
What Does a Full INVIMA Legal Service Include?
1. Initial Regulatory Diagnosis
- We verify whether your registration meets all current criteria (semantic standard, labeling, traceability, etc.).
- We identify common errors in your file.
2. Legal + Technical Advisory with a Multidisciplinary Team
- We translate regulatory requirements into clear action steps.
- We ensure every technical document has valid legal support.
- We perform an exhaustive review to minimize INVIMA rejections, speeding up approval and making your process more efficient.
3. Preparation and Review of Legal Annexes
- Certificates, letters of representation, declarations, manufacturer contracts, apostilled translations, and other required documents.
4. Submission and Legal Representation before INVIMA
- We draft legal responses to official requirements, orders, or observations.
- We directly monitor your case using the right legal language.
- We accompany your company in dealings with INVIMA, managing appointments and official actions to ensure a smooth process.
5. Continuous Monitoring and Updates
- We track changes in regulations.
- We alert you to new obligations or risks of cancellation or fines.
- We anticipate rejections, allowing you to focus exclusively on marketing your product.
Risks of Not Having Adequate Legal Support
- Loss of registration due to errors in semantic coding.
- Fines for documentary inconsistencies or missing legal support.
- Delays of up to 12 months due to reprocessing with INVIMA.
- Inability to market in Colombia.
- Frequent mismatches between labels, trademarks, packaging, and references can cause import clearance rejections — leading to storage costs and reprocessing delays.
Real Case (Anonymous, Summarized)
An international company tried to register a diagnostic device without legal support. INVIMA returned the file twice due to an incorrect trade name and wrong risk classification. On the third attempt, with Nieto Lawyers’ legal and technical guidance, the process was approved in record time.
Why Work with Nieto Lawyers?
- We are a law firm specialized in Health Regulatory Law.
- Our multidisciplinary team includes biomedical engineers, pharmaceutical chemists, doctors, veterinarians, industrial engineers, and lawyers with expertise in INVIMA regulations.
- More than 40 Class IIb medical device companies advised successfully.
- Experience in handling requirements, semantic standards, and product stock issues.
- Direct contact with INVIMA staff to know the real status of your processes.
Is your file already at INVIMA and you’re unsure if it’s on track?
We offer a free review of your documentation and compliance status.
Or contact us on WhatsApp to get your first guidance in less than 24 hours.
WhatsAppFrequently Asked Questions
Do lawyers handle INVIMA’s semantic standard?
Yes. The semantic standard has both legal and technical implications. At Nieto Lawyers, we work with a chemical expert and regulatory as to ensure full compliance.
What if I don’t have legal support for my INVIMA process?
You risk delays, rejections, or penalties if you submit incomplete, incorrect, or unsupported documentation.
How much does an INVIMA legal service cost?
Depending on complexity, from COP $350,000 or to 170 USD and up. Your first review with Nieto Lawyers is free.
