April 21, 2023
The Regulatory Affairs in Colombia are implemented to protect the public when they are consuming products that could affect their health. In this sense, products such as, food, medicines, psychotherapeutics, dietary supplements, cosmetics, alcoholic beverages, medical devices, veterinary applications, among others, will need necessary permits granted by the corresponding authorities to be sold. Hence, in order to sell these kinds of products in Colombia, the company or business will need the respective approval granted by the INVIMA (National Food and Drug Surveillance Institute).
The INVIMA Sanitary Registration is mandatory for all products with a name and brand that will be sold to a consumer in Colombia. This certification document guarantees that a product circulates legally in the country and that it also complies with the technical requirements required by law.
For companies who are selling and making products who will be consumed by the public, most likely certifications and permits will be needed to market said products in Colombia. This documents will be processed before the INVIMA, which is why here at AGT Attorneys we recommend receiving specialized legal advice on Regulatory Affairs by a lawyer when handling such processes.
We are a Colombian law firm, with experience in health and regulatory law in Colombia, that will assist you through all the legal procedures required for your products like medical devices. Contact us by filling the next Contact Form or through our WhatsApp number +57 310 5706331.
At 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 that required regulatory affair certifications and/or permits include medical devices, food products, and cosmetics.
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.
In Colombia, medical equipment can be categorized into one of four classes: Class I, Class IIa, Class IIb, and Class III. These classifications indicate levels of risk, with Class I being low risk, Class IIa and IIb representing medium and high risk, respectively, and Class III reserved for very high-risk devices.
According to the several requirements and characteristics mentioned above, your medical device will be classified. If you are seeking legal advice regarding the classification applicable for your equipment, do not hesitate to contact us here at AGT Attorneys and book a specialized consultation with one of our experienced lawyers on Regulatory Affairs in Colombia.
According to the Article 38 of the Resolution 2674 from 2013, the requirements to import products are:
In AGT Attorneys, 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 in Colombia, which will be presented to consumers with their respective INVIMA health registration number.
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