How to Get a Regulatory Affair in Colombia?
July 28, 2020
If you want to get a Regulatory Affair to import to Colombia products as: food, medicines, phytotherapeutics, dietary supplements, cosmetics, alcoholic beverages, medical devices, veterinary applications, or other products for human use or mass consumption, your business will need the respective approval granted by the INVIMA (National Surveillance Institute of Drugs and Foods).
Invima sanitary registration is mandatory for all products with a name and brand that is sold directly to the final consumer in Colombia. This document guarantees that a product circulates legally in the country and that it complies with the technical requirements established by law.
In the case of medical devices, INVIMA needs an existing regulatory affair agreement of mutual recognition with Colombia by GHTF-founding members such as United States of America, Japan, Canada, European Union and Australia.
If you want to get a regulatory affair for your products, we recommend you to ask for an appointment with a Colombia legal representative to assist you in your regulatory approval process. Our law firm is specialized in the health and regulatory law, contact us by filling the next Contact Form.
Our Expert Lawyers in Sanitary and Regulatory Affairs can Give you Advice in:
- INVIMA Registration.
- Consultancy on feasibility.
- Preparation of documentation.
- Collection of information.
- Process monitoring.
- Notification of results.
On the other hand, there are several steps in the process that can confuse anyone who is not familiar with the process: what products can be covered under the same sanitary registration, how to properly complete the application forms, what is the appropriate payment rate according to the procedure to request, how long it takes a record to expire, when a health record must be renewed, among other important aspects at the time of beginning a registration request.
In AGT AGT Attorneys, we work with all the industrial sectors to advise them on these regulatory affairs and health issues before the different public entities of the country. The most common products of getting a regulatory affair in Colombia are medical devices and food products, so we are going to talk about some important information then.
Which are the Regulatory Affairs for Medical Device in Colombia?
Colombia's INVIMA medical device classification system is based on the potential health risk related to the use and possible failure of a device. The criteria used involves the duration of contact with the body, how invasive the device is, and local effect vs systemic effect.
- Low risk
- Subject to general manufacturing controls
- No potential harm of disease or injury
- Not destined to protect or maintain life
- Made to prevent the deterioration of human life
- Examples: Surgical instruments, gauze
- Moderate risk
- Subject to special manufacturing controls to demonstrate their safety and efficacy
- Example: Hypodermic needles, suction equipment
- High risk
- Subject to special controls in their design and manufacturing to show safety and efficacy
- Example: Pulmonar ventilator, orthopedic implants
- Very high risk
- Subject to special controls to protect or maintain life
- Made to prevent the deterioration of life
- Their use represents a potential health risk or injury
- Example: Heart valves, pacemakers
ABC de Dispositivos Médicos (INVIMA)
This Class orders, are differents for each type of products, so if you want to know the classification of your product, yo can contact our professionals for other regulatory affair matters by calling our phone number at: +57 1 702-3671.
Which are the Regulatory Affairs to Import Food Products to Colombia?
According to the Article 38 of the 2674 Resolution from 2013, the requirements to import products are:
- Form corresponding to the procedure.
- Certificate of existence and legal representation of the owner and the manufacturer.
- Payment receipt, the amount of which must coincide with that indicated in the INVIMA rate.
- Free sale certificate issued in the country where the food product comes from. It is very important to highlight that if this document is not written in the Spanish language, the official translation of it must be attached.
- Document signed by the producer where the importer is authorized to introduce the food to the country, distribute it, market it; or to be the holder of the sanitary registration of the product in Colombian territory.
- Technical data sheet of the food product according to the format defined by Invima.
- Important note: If you are carrying out the procedure through an advisor, you must enter the corresponding power of attorney.
Do you Need to Get a Regulatory Affair Lawyers in Colombia?
In AGTAttorneys, we advise and guide companies in all industrial sectors to carry out their regulatory affairs in Colombia. Having our support to carry out your Invima health registration, will guarantee you the possibility of legally enabling the circulation of your product, which will be presented to consumers with their respective Invima health registration number.
If you found this article of regulatory affair helpful then let us know in the comments section below. Likewise, feel free to share it using the share options below.
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