Hygienic products, typically thought of as substances for personal cleanliness, hold a unique position in Mexico’s regulatory landscape. Classified as medical devices, these products fall under the scope of COFEPRIS, requiring sanitary registration to be commercialized in the country. In this article, we briefly describe the characteristics and regulatory requirements surrounding these products.
Defining Hygienic Products in Mexico
Mexico’s General Law of Health provides a specific definition for hygienic products based on their intended use. They are materials and substances applied to the skin or body cavities with pharmacological or preventive action. In essence, any hygienic product containing a pharmacological substance and formulated for a specific use or prevention must be considered a medical device.
Classification of Risk
The Supplement of Medical Devices, through the Rule 22, outlines the risk classification for hygienic products. Products used externally (skin, nails, hair, lips, mouth, nose) and not absorbed by mucosal membranes generally fall into Class I. However, vaginal or genital lubricants are classified as Class II, indicating a higher risk profile.
Specific Requirements for Registration
Registering hygienic products as medical devices involves meeting specific requirements:
- Composition: A detailed declaration of the qualitative and quantitative formulation, including all ingredients, is mandatory.
- Active Pharmaceutical Ingredients (APIs): If the product contains an API, comprehensive information, including Drug Master File (DMF), Good Manufacturing Practice (GMP) certificate, and Certificate of Analysis (CoA), must be submitted.
Advertising Considerations
In general, hygienic products can be advertised to the general public. However, it is crucial to confirm advertising permissions with COFEPRIS once the sanitary registration is approved.
Conclusion
The classification of hygienic products as medical devices in Mexico emphasizes the importance of ensuring their safety and efficacy. While these products are designed for personal hygiene, their potential pharmacological or preventive action involves a regulatory framework. Understanding the specific definition, risk classification, registration requirements, and advertising considerations is crucial for manufacturers and distributors intending to bring their hygienic products for the Mexican market.
If you have doubts if your hygienic product is considered a medical device in Mexico, please contact us at contact@veraqueconsulting.com.
