Your Guide to Prohibited Products: Medicines and Medical Devices
Let's remember that all medical devices (Class I, II and III) and medicines (both over-the-counter and prescription) are prohibited from being sold at TikTok Shop Mexico.This guide aims to define what qualifies as a medical device or medicine and to provide definitions and examples to support identification, in order to prevent prohibited listings and potential enforcement actions.
Medical Devices
A medical device is any instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance, or similar product intended to be used, alone or in combination, directly or indirectly on human beings, for one or more of the following purposes:- Diagnosis, prevention, surveillance or monitoring, and/or assisting in the treatment of diseases
- Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or assisting in the healing of an injury
- Replacement, modification, or support anatomy or physiological processes
- Life support
- Conception control
- Disinfection of medical devices
- Disinfectant substances
- Provision of information through in vitro examination of samples taken from the human body for diagnostic purposes
- Devices that incorporate tissues of animal and/or human origin; and/or
- Devices used in in vitro fertilization and assisted reproduction technologies.
In Mexico, according to this definition, the devices can range from a thermometer to high-tech equipment.Reference: NOM-241-SSA1-2021
Medical Devices Classification
Why are medical devices classified?Classification helps regulators determine:- How strict safety controls should be
- How much testing is required before use
- How closely products should be monitored after they reach users
- Understand what types of products are considered medical devices
- Recognize that even “simple” tools still fall under medical regulations
- Avoid mistakenly listing products that seem harmless but are regulated
Class I:
Medical devices well-known in medical practice whose safety and effectiveness have been proven, and which generally are not introduced into the body.Examples:
- Thermometers (non-digital or basic digital)
- Stethoscopes
- Mechanical blood pressure cuffs
- Bandages, gauze, and adhesive plasters
- Crutches, walkers, and wheelchairs
- Surgical instruments that do not remain in the body (e.g., scalpels, forceps)
Class II:
Medical devices well-known in medical practice that may vary in the materials from which they are made or in their concentration, and which are generally introduced into the body for less than thirty days.Examples:
- Contact lenses (daily/weekly)
- Disposable catheters
- Blood glucose meters and test strips
- Nebulizers
- Odontological materials
- Short-term implants
- Menstrual Cups
Class III:
Medical devices that are new or recently accepted in medical practice, or that are introduced into the body and remain there for more than thirty days.Examples:
- Pacemakers
- Permanent or long-term implants (hip, knee, or spinal implants)
- Breast implants
- Intrauterine devices (IUDs)
- Heart valves
Please keep yourself informed of local regulations to be able to identify if your product is considered a medical device in Mexico
Medicines
A medicine is any substance or mixture of substances of natural or synthetic origin that is presented as having therapeutic, preventive, curative, rehabilitative, or diagnostic effects, or that is intended to be administered to humans to:- Prevent diseases
- Diagnose diseases or health conditions
- Alleviate symptoms
- Treat or cure diseases
- Restore, correct, or modify physiological functions through pharmacological, immunological, or metabolic action
Medicines Classification
Medicines in Mexico generally fall into the following categories:Prescription medicines (RX):
Require a medical prescription due to their strength, risks, or need for medical supervision. Examples:- Antibiotics (e.g., amoxicillin, azithromycin)
- Antidepressants
- Antipsychotics
- Prescription-only antihypertensives
- Prescription hormonal treatments
- Injectable diabetes medications
- Controlled substances for pain management
- Semi-glutides (GLP-1, Ozempic)
- Alopecia treatment (Finasterida)
Over-the-counter (OTC) medicines:
Available without a prescription, usually for common conditions. Examples:- Pain relievers and fever reducers (e.g., acetaminophen, ibuprofen)
- Cold and flu medications
- Antacids and digestive aids
- Mild allergy medicines (non-prescription antihistamines)
- Cough syrups
- Non-prescription topical creams or ointments
- Alopecia treatment (Minoxidil)
Biotechnological or biological medicines:
Produced from living organisms or biological processes; regulated with higher controls due to their complexity and risk. Examples:- Vaccines
- Monoclonal antibodies
- Recombinant hormone therapies
- Blood-derived or plasma products
- Specialized immunotherapies
Herbal or homeopathic medicines:
Considered as medicines when promoted with therapeutic claims. Examples:- Herbal capsules claiming treatment for a condition
- Homeopathic drops marketed for specific symptoms
- Plant-based syrups with medicinal claims
- Natural extracts promoted with therapeutic use
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