Sanitizers in regulatory terms are complex products. In some countries, they are classified as cleaning products, cosmetics or biocides. In addition, their sanitary authorization is not required in all countries. This is not the case for Colombia, in which sanitizers can be classified as medical devices or require to comply with Colombian Norms. In this article we will discuss about the different cases.
Sanitization and disinfection definitions
First, it is worth mentioning that in Colombian regulatory landscapes the word “disinfectant” and related terms are widely more used to refer to these kinds of products.
Regarding definitions, the Decision 706 of 2008 defines disinfectant as an agent that eliminates most pathogenic microorganisms but not necessarily all spore-forming microbial forms on inanimate objects and surfaces. Disinfection is defined by the Ministry of Health and Social Protection as the destruction of microorganisms on a surface by means of chemical or physical agents.
There are formulations in the market used for disinfection or sanitization of skin (mainly hands) or surfaces respectively, for example:
- Alcohol based solutions
- Non-alcoholic solutions
- Quaternary ammonium salts
- Benzalkonium chloride compounds
All the above-mentioned products can be sold as liquid, gel, foam, wet towels, creams, soap or other presentations.
The Medical Device case
Based on the different type of presentations and intended uses, the key points to consider these products as medical devices in Colombia are:
- If the product is specifically intended for the disinfection of medical devices.
- If the product is not considered as domestic hygiene products and/or absorbent personal hygiene products in accordance with Decision 706 of 2008.
If the product covers at least one of the points mentioned above, then it will be regulated by INVIMA as a Class IIa Medical Device by Rule 15 and it will need a Sanitary Registration.
Conclusion
Classification of sanitizers and disinfectants in Colombia can be a delicate subject without the proper context. But often, a good and early assessment can save time on preparing the proper documentation for the corresponding registration procedure.
If you have additional questions about the sanitizers or disinfectants regulations in Colombia, please contact us at contact@veraqueconsulting.com or check our Guidelines.
