DINAVISA Import Requirements — Cosmetics, Supplements, CBD

Authority: DINAVISA (Dirección Nacional de Vigilancia Sanitaria), under MSPBS (Ministerio de Salud Pública y Bienestar Social) Site: https://dinavisa.gov.py Last verified: June 19, 2026

The 4 regulatory buckets for Sexitive's catalog

Sexitive's 12 SKUs fall into 4 different DINAVISA categories. Each has a different registration process, timeline, and cost. Misclassifying a product is the #1 way to lose money at customs.

Bucket 1 — Cosméticos (lubricants, body oils, candles, topical sprays)

Covers: Wet line, more sex, Love Potion, Bitchie spray, XXX For Her, massage candles

Regulatory basis: Resolución DINAVISA N° 371/2024 (clasificación, requisitos, renovación de registros sanitarios y NSO).

Process: 1. Registro Sanitario — product-by-product registration with DINAVISA. - Documents: certificate of free sale from country of origin, formulation, labeling, manufacturing process, stability data. - Sexitive AR must provide these — Sarah cannot import without them. 2. Notificación Sanitaria Obligatoria (NSO) — for some low-risk cosmetics, an NSO may suffice in lieu of full registration (faster, cheaper). Check per-SKU with despachante. 3. Certificado de Libre Venta — issued by ANMAT (Argentina's regulator) for Sexitive's products. Required. 4. Traducción pública — Spanish translation of all labeling, done by a Traductor Público matriculado. 5. Etiquetado conforme a MSPBS — labels may need adjustment to comply with Paraguayan regulations (Spanish language, RUC of importer, local contact).

Timeline: 60–120 days per SKU for full registration; 15–30 days for NSO. Cost estimate: Gs 1.5M – 4M per SKU (full registration); Gs 300K – 800K per SKU (NSO). Confirm with despachante.

Bucket 2 — Suplementos Dietarios (Pink Sexy Pill only)

Covers: Pink Sexy Pill (4 tablets, libido supplement with ginseng, L-Arginina, etc.)

Regulatory basis: Resolución DINAVISA N° 234 (régimen de obtención y renovación de constancia de inscripción sanitaria para suplementos dietarios).

Process: 1. Constancia de Inscripción Sanitaria — separate from cosmetic registration. 2. Composición cualicuantitativa — full ingredient disclosure with doses. 3. Certificado de Libre Venta from ANMAT. 4. Estudio de estabilidad — stability data may be required. 5. Dictamen técnico — DINAVISA technical opinion on formulation.

Timeline: 90–180 days. Longest timeline in the catalog. Cost estimate: Gs 4M – 8M. Most expensive per SKU. Risk: DINAVISA may reject the formulation if it contains ingredients not on the approved list for PY supplements.

Bucket 3 — Cosmético con CBD (My Hemp only)

Covers: My Hemp 15ml CBD body oil.

Regulatory status: Zona gris en Paraguay. CBD topicals are not explicitly regulated: - Not in the supplement category (it's topical, not ingestible). - Not clearly in the cosmetic category because CBD is a novel active. - No clear DINAVISA pathway exists as of June 2026.

Options: 1. Skip My Hemp at launch — lowest-risk option. 2. Apply for cosmetic registration with CBD declared as active — DINAVISA may accept or reject. No precedent. 3. Import as "cosmetic body oil" without declaring CBD on the customs declaration — illegal; if caught at customs, seizure and possible fine. 4. Wait for SENAD (Secretaría Nacional Antidrogas) clarification on CBD cosmetics — could take 6–18 months.

Recommendation: Skip My Hemp at launch. Re-evaluate in 6 months when regulatory landscape may be clearer.

Bucket 4 — Edible-flavored (more sex line)

Covers: more sex — Berries, Chocolate, Dulce de Leche (50ml flavored edible gels)

Regulatory consideration: Edible = food-adjacent. Even though they're sold as lubricants, the "edible" claim may trigger INAN (Instituto Nacional de Alimentación y Nutrición) review.

Likely outcome: Classified as cosmetics with food-grade flavoring, not as food products. Confirm with despachante before launching.

General import process (all buckets)

1. Sarah obtains RUC (if not already)         [Sarah]
2. Sarah engages a Despachante de Aduanas      [Sarah + despachante]
3. Sarah secures DINAVISA registration/NSO     [Sarah + DINAVISA]
   per SKU category
4. Sexitive AR provides Certificado de         [Sarah + Sexitive AR]
   Libre Venta + formulation docs + labels
5. Spanish translation + labeling adjust       [Traductor + designer]
6. First shipment: AR→PY freight               [Freight forwarder]
7. Customs clearance via VUI                   [Despachante]
8. DINAVISA final inspection of shipment       [DINAVISA]
9. Product released to Sarah's warehouse        [Sarah]

Total time from RUC to first product on shelf: 90–180 days for the simplest SKU (cosmetic with NSO); 180–365 days for the full 12-SKU catalog including Pink Sexy Pill and (if attempted) My Hemp.

Age-restriction considerations

Paraguayan law does not have a clear minimum age for purchasing intimate products. However:

• Best practice: state "18+" on packaging, on the site, and in WhatsApp catalog.
• Use age-gate on the website (pop-up "Confirmo que soy mayor de 18 años").
• Refuse sales to minors if a customer identifies as such in chat.
• This protects Sarah from any future regulatory tightening.

What Sarah should ask the despachante (today)

1. "¿Cuál es el costo y plazo de registro sanitario para cada categoría de producto Sexitive?" (cosmetic, supplement, CBD)
2. "¿Qué SKUs pueden usar NSO en vez de registro completo?"
3. "¿Necesito registro de establecimiento además del registro de producto?" (likely yes for the import operation)
4. "¿Qué pasa si importo sin registro y me agarran en aduana?" (confiscation + fine; not worth it)
5. "¿Hay un régimen simplificado para PYMEs importadoras?" (possibly; small importer regime)
6. "¿Cuánto cuesta su servicio de despachante por embarque?" (typically Gs 800K – 1.5M per shipment)

A reliable despachante in Asunción can be found via: - Aduana del Paraguay list of registered despachantes - Recommendation from Sexitive AR (they may have a PY freight partner) - Paragu-ai network (Kiki may know one)

Cost estimate summary (DINAVISA + despachante, all 12 SKUs)

These are estimates. The despachante quote is the source of truth.

What happens if Sarah skips DINAVISA

The cost of compliance is much lower than the cost of non-compliance. Do not skip.