Invima Issues Digital Certificates for Production Capacity, BPM, Manufacturing Norms, Sanitary Conditions
- bogotá, March 18, 2025 - The Instituto Nacional de Medicamentos y Alimentos (INVIMA), Colombia's National Institute for the Surveillance of Medicines and Foods, is taking a notable step...
- This digital shift impacts certificates related to production capacity,Good Manufacturing practices (BPM),technical manufacturing standards,and sanitary conditions for a range of products.
- The move aims to eliminate the need for individuals to travel to INVIMA's headquarters to collect these essential documents.
INVIMA Modernizes: Digital Certificates Rollout in Colombia
Table of Contents
- INVIMA Modernizes: Digital Certificates Rollout in Colombia
- INVIMA Digital Certificates: Your Questions Answered (2025 Update)
bogotá, March 18, 2025 – The Instituto Nacional de Medicamentos y Alimentos (INVIMA), Colombia’s National Institute for the Surveillance of Medicines and Foods, is taking a notable step towards modernization. Starting March 24, 2025, the agency will exclusively issue and send certificates digitally.
Digital Conversion of INVIMA Certificates
This digital shift impacts certificates related to production capacity,Good Manufacturing practices (BPM),technical manufacturing standards,and sanitary conditions for a range of products. These include cosmetics, household cleaning and hygiene products, pesticides, and personal hygiene absorbents.
The move aims to eliminate the need for individuals to travel to INVIMA’s headquarters to collect these essential documents. This will streamline access and reduce operational costs for users. Notifications and certificate delivery will occur via email at notificacionescos@invima.gov.co, sent to the address registered by the applicant in the “correo electrónico de notificación” field of the ASS-AYC-FM160 application form.
Key Benefits of the Digital System
- Avoid unnecessary travel.
- Reduce paper usage, contributing to environmental sustainability.
- Receive certificates quickly and securely via email.
- Guarantee the legal validity of documents without the need for a physical seal.
- Enjoy easy and permanent access to digital certificates.
Ensuring Validity and Security of Digital Certificates
INVIMA emphasizes the validity and security of the new digital certificates. “En cumplimiento de lo establecido en el artículo 20 de la Ley 962 de 2005, no será necesario que los documentos cuenten con un sello seco para su validez.” This means that a physical seal is not required for the certificates to be valid.
The digital certificates will have full legal validity, as stipulated in Article 40 of Law 1437 of 2011 and Article 46 of Law 1564 of 2012.
Streamlined Apostille and Online Verification Processes
INVIMA and the Ministry of Foreign Affairs have collaborated to facilitate online verification for digital certificates requiring apostille. This interoperability tool eliminates the need for users to present an original physical document for this process.
Quote from INVIMA
This initiative reinforces INVIMA’s commitment to efficiency and the digitalization of its services.
From the established date, this digital method will be the sole means of issuing and delivering these certificates. This change underscores INVIMA’s dedication to efficient and digitized services.
For more information, visit www.invima.gov.co or contact notificacionescos@invima.gov.co.
INVIMA Approval Process for Medical Devices
INVIMA ensures that medical devices meet standards of “safety, efficacy, and quality.” The process involves:
- Submission to INVIMA: Submit the complete dossier for review. Ensure all documents meet Colombian regulatory requirements.
- Review Process: INVIMA checks compliance with safety and efficacy standards. They assess if the technical and clinical data are adequate.
- Approval and Issuance: If approved, INVIMA issues a registration certificate.
INVIMA Digital Certificates: Your Questions Answered (2025 Update)
The Instituto Nacional de medicamentos y Alimentos (INVIMA) in Colombia is modernizing its certification process. Starting March 24, 2025, INVIMA will exclusively issue and send certificates digitally. This Q&A guide provides essential information about this transition.
General information about INVIMAS Digital Transformation
What is INVIMA and what does it do?
INVIMA, which stands for Instituto Nacional de Medicamentos y Alimentos, is colombia’s National Institute for the Surveillance of Medicines and Foods. It is indeed responsible for ensuring the safety,efficacy,and quality of various products,including medicines,food,medical devices,cosmetics,and more. INVIMA’s role is similar to that of the FDA in the United States.
What certificates are affected by this digital shift?
The digital shift affects certificates related to:
production capacity
Good manufacturing Practices (GMP) – BPM in Spanish
Technical manufacturing standards
Sanitary conditions
These certificates apply to a range of products, including:
Cosmetics
Household cleaning and hygiene products
Pesticides
Personal hygiene absorbents
When did INVIMA begin issuing digital certificates?
INVIMA started exclusively issuing and sending certificates digitally on March 24, 2025.
How will I receive my digital certificates from INVIMA?
Notifications and certificate delivery will occur via email at notificacionescos@invima.gov.co. Make sure this email is on your safe sender list. The email will be sent to the address registered by the applicant in the “correo electrónico de notificación” field of the ASS-AYC-FM160 application form.
What are the benefits of INVIMA’s digital certificate system?
The digital system offers several key advantages:
Avoid unnecessary travel: No more trips to INVIMA’s headquarters to collect documents.
Reduce paper usage: Supporting environmental sustainability.
Receive certificates quickly and securely: Delivered directly to your email.
Guaranteed legal validity: Documents are valid without a physical seal.
Easy and permanent access: Certificates are stored digitally for easy retrieval.
Validity and Security of Digital Certificates
Are INVIMA’s digital certificates legally valid?
Yes,INVIMA emphasizes the validity and security of the new digital certificates. A physical seal is not required for the certificates to be valid,as stated in Article 20 of Law 962 of 2005.The digital certificates have full legal validity,as stipulated in Article 40 of Law 1437 of 2011 and Article 46 of Law 1564 of 2012.
Do I need a physical seal for my INVIMA digital certificate to be valid?
No. In compliance with Article 20 of Law 962 of 2005, a physical seal is not required for the certificates to be valid.
Apostille and Verification
How does the online verification process work for digital certificates requiring an apostille?
INVIMA and the Ministry of Foreign Affairs have collaborated to facilitate online verification for digital certificates requiring an apostille. This interoperability tool eliminates the need for users to present an original physical document for this process. This means you can verify the authenticity of your certificate online, streamlining international use.
INVIMA Approval Process for Medical Devices
what are the steps in INVIMA’s medical device approval process?
INVIMA ensures medical devices meet standards of safety, efficacy, and quality. The process involves:
- Submission to INVIMA: Submit the complete dossier for review, ensuring all documents meet Colombian regulatory requirements.
- Review Process: INVIMA checks compliance with safety and efficacy standards, assessing the adequacy of technical and clinical data.
- Approval and Issuance: If approved, INVIMA issues a registration certificate.
What is needed for medical device registration?
Based on the search results, here are key requirements for INVIMA medical device registration:
In-Country Representative: Appoint a legal representative if you don’t have a local presence in Colombia.
Certificate of Free Sale (CFS): Obtain a CFS or Certificate to Foreign Government (CFG) from your home country or an INVIMA-recognized market.
Quality System Certificate: Provide a quality system certificate, such as ISO 13485.
* Technical Requirements: Prepare technical documents, including GMP certificate, product description, technical studies, and a declaration of conformity.
How long are INVIMA registration certificates valid?
According to search result 2, registration certificates in Colombia are valid for 10 years. Renewals are due to INVIMA three months before the expiration of your registration certificate.
Summary Table: Key Aspects of INVIMA’s Digital Certificates
| Feature | Description |
| ———————- | ————————————————————————————————————————————————- |
| Implementation Date | March 24,2025 |
| Delivery Method | Email to notificacionescos@invima.gov.co |
| Affected Certificates | Production capacity, GMP, technical manufacturing standards, sanitary conditions for cosmetics, cleaning products, pesticides, hygiene products. |
| legal Validity | Valid without a physical seal (Law 962 of 2005, Article 20; Law 1437 of 2011, Article 40; Law 1564 of 2012, Article 46) |
| Apostille Process | Streamlined online verification, no physical documents needed |
Further Information
Where can I find more information about INVIMA’s digital certificates?
For more information, visit www.invima.gov.co or contact notificacionescos@invima.gov.co.