If your business is related to food, beverages, supplements, cosmetics, health services, or medical products, you need to comply with COFEPRIS sanitary notices. This is the health authority in Mexico that regulates everything that impacts people’s health.
In this article, I explain what COFEPRIS is, what procedures exist, who needs them, and how to comply with regulations to operate without legal risks.
📌 What is COFEPRIS?
COFEPRIS (Federal Commission for Protection against Health Risks) is the agency responsible for regulating and controlling products, services, and establishments that can affect public health.
Its main function is to protect consumers by ensuring products and services comply with established health standards.
⚠️ Important: Operating without the corresponding sanitary notices can result in fines, closures, or even product seizure.
🧾 What Are Sanitary Notices?
Sanitary notices are the procedures through which you inform COFEPRIS that you will operate an establishment, manufacture a product, or carry out a regulated activity. There are two main categories:
1. Operation Notice
Filed before starting operations of an establishment. Applies to:
- Restaurants, cafeterias, dining halls
- Beauty salons, barbershops, spas
- Clinics, medical offices, laboratories
- Pharmacies, health food stores
- Gyms, sports centers
💡 It is not prior authorization, it is a notification. But if you don’t file it, you cannot operate legally.
2. Health Responsible Party Notice
Designates the person in charge of ensuring the establishment complies with health standards. It is mandatory for:
- Food and beverage establishments
- Health establishments
- Pharmacies and laboratories
⚠️ The health responsible party must have a professional license in areas such as nutrition, chemistry, biology, pharmacy, or medicine.
👤 Who Needs COFEPRIS Procedures?
All businesses that fall under these categories must comply with health regulations:
| Category | Examples |
|---|---|
| Food and beverages | Restaurants, cafeterias, diners, industrial kitchens, food processors, craft breweries |
| Supplements and nutraceuticals | Manufacturers, distributors, importers |
| Cosmetics and personal care | Manufacturers, importers, beauty salons |
| Medical products | Manufacturers, distributors, pharmacies |
| Health services | Clinics, medical offices, laboratories, hospitals, medical spas |
| Chemical substances | Manufacturers, distributors |
| Tobacco and alcoholic beverages | Commercial distributors, importers |
💡 If your business touches health or human consumption, you likely need a sanitary notice.
📋 Types of COFEPRIS Procedures
For establishments:
| Procedure | Description | Deadline |
|---|---|---|
| Operation notice | Notification to operate an establishment | Before opening |
| Health responsible party notice | Designation of health supervisor | Before opening |
| Sanitary license | Permit to manufacture products | Prior to manufacturing |
For products:
| Procedure | Description | Validity |
|---|---|---|
| Sanitary registration | Authorization to commercialize a product | 5 years (renewable) |
| Sanitary notification | For low-risk products (some cosmetics, supplements) | 5 years |
⚠️ Sanitary registrations are mandatory for medications, miracle products, supplements with specific properties, and medical devices.
📋 General Requirements for Operation Notice
Requirements may vary by business type, but generally include:
Basic documentation:
- Notice application form (COFEPRIS format)
- Official ID of owner or legal representative
- Proof of address of the establishment
- Municipal operating license
- Land use permit
Technical documentation (depending on business type):
- Architectural plan of the establishment
- List of equipment and utensils
- Cleaning and disinfection program
- Temperature control (for food businesses)
- Supplier records
- Food handling training certificate (for food businesses)
💡 You can check specific requirements on the COFEPRIS portal.
🧭 How to Complete the Procedure?
Step by step:
1. Identify the procedure you need
Based on your business type, determine whether you need an operation notice, sanitary registration, or both.
2. Prepare your documentation
Gather all requirements according to your business type. Ensure they are complete.
3. Enter the COFEPRIS portal
The procedure is completed online through the COFEPRIS Single Window.
4. Complete the form and attach documents
Follow the system instructions and upload the required files.
5. Make the payment
Generate the payment slip and pay the corresponding fees.
6. Receive your acknowledgment
Once submitted, you receive an acknowledgment proving you filed the notice.
⚠️ The operation notice does not require prior approval, but it must be filed before operating.
⏳ Timelines and Approximate Costs
| Procedure | Timeline | Approximate Cost |
|---|---|---|
| Operation notice | Immediate (acknowledgment) | $1,000 – $3,000 MXN |
| Health responsible party notice | Immediate (acknowledgment) | $500 – $1,500 MXN |
| Sanitary registration | 30 – 90 business days | $5,000 – $15,000 MXN |
| Sanitary notification | Immediate to 15 days | $2,000 – $5,000 MXN |
💡 Costs vary by product type, establishment size, and procedure duration.
🔍 COFEPRIS Inspections
COFEPRIS conducts verification visits to ensure establishments comply with regulations.
What do they inspect?
- Sanitary conditions of the establishment
- Food or product handling
- Documentation and notices
- Designated health responsible party
- Control records
What happens if you don’t comply?
- Financial fines
- Temporary closure
- Permanent closure
- Product seizure
⚠️ Fines can range from a few thousand to hundreds of thousands of pesos, depending on the severity of the violation.
🧪 Food Business: Specific Requirements
If your business involves food and beverages, in addition to the operation notice, you need:
- Food handling: Mandatory training for food handlers
- Temperature control: Refrigerators and measuring equipment
- Cleaning and disinfection program: Documented protocol
- Pest control: Fumigation records
- Water supply: Water quality certificate
💡 Restaurants and industrial kitchens require prior inspection in some municipalities.
🧪 Health Business: Specific Requirements
If your business involves health services (clinics, medical offices, laboratories):
- Health responsible party with professional license
- Sanitary license for the establishment
- Medical equipment registration
- Hazardous biological-infectious waste management program
- Sterilization control
⚠️ Health establishments have stricter requirements due to health risk.
🔄 Relationship with Other Procedures
COFEPRIS sanitary notices are connected to:
- Municipal operating license: Required for the sanitary notice
- Land use permit: Base requirement
- Civil Protection approval: Required for inspection
- Trademark registration with IMPI: For commercialized products
💡 Without the sanitary notice, you cannot legally operate in regulated businesses.
📚 Useful Internal Links
- Operating License in Mexico
- Land Use Permit: Complete Guide
- Civil Protection Approval
- Legal Procedures to Register Your Business
✅ Conclusion
COFEPRIS sanitary notices are not optional if your business involves food, health, or consumer products. Complying with regulations not only avoids penalties but also protects your customers and strengthens trust in your brand.
Remember:
- Identify whether your business requires an operation notice or sanitary registration
- Designate a health responsible party if mandatory
- Keep your facilities and processes in order for inspections
- Complete the procedures before starting operations
A regulated business is a reliable business. Comply with COFEPRIS and operate with peace of mind.
