Brands navigated through COFEPRIS compliance with Tally. From viability analysis to Registro Sanitario — supplements, cosmetics, food, and medical devices.
Any product that contacts the human body must comply with Mexico’s health authority.
| Product Category | Regulation Level | Typical Timeline | Key Permit |
|---|---|---|---|
| Cosmetics | Low | 3 – 15 days | Aviso de Funcionamiento |
| Food & Beverages | Medium | 1 – 3 months | Aviso + Import Permit |
| Dietary Supplements | High | 3 – 6 months | Aviso + Permiso Sanitario |
| Supplements (Registro) | Very High | 6 – 12 months | Registro Sanitario |
| Medical Devices (Class I–III) | Very High | 6 – 18 months | Registro Sanitario |
| Pharmaceuticals | Maximum | 12 – 24 months | Registro Sanitario |
Comprehensive regulatory support from ingredient analysis to market launch.
Preventive ingredient analysis before you invest in production. We determine if your product can legally enter Mexico and flag any prohibited or restricted substances.
Government registration declaring your company will store or sell health products. Required before any regulated product can be imported. We handle the full filing.
The “sales permit” for complex products: medications, medical devices, and certain supplements. Full dossier preparation and submission to COFEPRIS.
Per-shipment import permit for regulated products. Required each time supplements, food, or health products cross the border. Valid for 30 days per permit.
We link a licensed health professional (with cédula profesional) to your entity to supervise operations. Legally required for all companies handling health products.
Design of compliant oversticker labels with all COFEPRIS-required warnings, nutritional tables, and ingredient lists. Our in-house team reviews labels 5× faster than traditional regulatory firms — averaging ~25 labels per month for high-volume clients.
Marketing compliance permit for advertising health products. Required before running any ad campaigns, influencer partnerships, or social media promotions for regulated products.
Compliance with mandatory Mexican standards for health products: NOM-050 (commercial labeling), NOM-141 (cosmetics), NOM-051 (food & beverage labeling with front-of-pack warnings).
Sanitary permits from Mexico’s animal and plant health authority. Required for animal-origin products, plant-based supplements, and agricultural goods.
Two things set Tally apart in COFEPRIS compliance.
Unlike brokers who outsource regulatory work, Tally has an integrated team of regulatory specialists with chemistry and legal backgrounds. Samantha and Adriana lead label reviews, ingredient analysis, and COFEPRIS submissions directly — no middlemen, no delays.
Before you invest in Mexican labeling, production runs, or import logistics, we analyze every ingredient against COFEPRIS regulations. If your product contains a prohibited substance, we catch it in week one — not after your container is stuck at customs. This saves our clients thousands in wasted production and shipping costs.
How Tally navigated COFEPRIS compliance for one of the largest supplement portfolios to enter the Mexican market.
The challenge: GROWVE, a US-based portfolio company managing 12+ supplement and wellness brands, needed to enter the Mexican market. Each brand required individual COFEPRIS viability analysis, compliant labeling, and Registro Sanitario submissions.
What we did: Tally’s in-house regulatory team ran viability reports on every SKU, designed NOM-compliant oversticker labels, and managed COFEPRIS filings for the entire portfolio simultaneously. We caught two prohibited ingredients in week one — before production started.
The result: All 12 brands cleared regulatory requirements. Entity formed in 4 weeks. First import cleared customs in week 10. GROWVE is now operational on Amazon Mexico.
“In general, Tally had been very responsive. They had been incredibly helpful.”
Any product that contacts the human body: dietary supplements, cosmetics, food products, beverages, medical devices, and pharmaceuticals. The level of regulation varies — cosmetics can be cleared in days, while medical devices may take over a year.
Cosmetics: 3–15 days. Food supplements: 3–6 months. Products requiring Registro Sanitario: 6–18 months. We begin all other setup steps (entity, banking, imports) in parallel so you’re ready to sell the moment your permit arrives.
A preventive ingredient analysis we conduct before you invest in production. It determines whether your product can legally be sold in Mexico and flags any prohibited or restricted substances.
A licensed health professional legally required to supervise operations involving health products in Mexico. Tally links qualified professionals to your entity on a monthly retainer basis.
Yes. NOM labels are mandatory for all consumer products entering Mexico. NOM-050 covers general commercial information. NOM-141 covers cosmetics. COFEPRIS permits and NOM labels are separate requirements but both are mandatory.
Viability reports, label reviews, and regulatory guidance included. Registro Sanitario quoted separately.
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