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Dental Supply Sanitary License — MSPAS DRCPFA
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Before clicking, have ready:
  • 📄 Form F-AS-f-01 (Sanitary License Application for Pharmaceutical Establishments)
  • 💰 Payment Slip V-CC-G-001 (current version)
  • 📚 Technical Standard 48-2020 "Distribuidoras" (download and read before applying)
  • 👨‍⚕️ Technical Director — licensed and active (dentist or pharmaceutical chemist)
  • 🏢 Warehouse set up with proper storage conditions
  • 🏛 Commercial license and NIT for the establishment
💰 Cost: Free (Q0) · ⏱ Time: 60 business days · 🆔 Verified: May 2026 (Catalogo Unico de Tramites del Estado, Service 3425)

The Dental Supply Sanitary License (Licencia Sanitaria para Depósito Dental) is the authorization that MSPAS issues through the Pharmaceutical Establishments Section of the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) for a dental supply business to open, operate, import, store and distribute dental products, equipment and instruments in Guatemala.

Quick summary: Free (Q0) procedure, 60 business days. Filed at the MSPAS DRCPFA using form F-AS-f-01. Governed by Technical Standard 48-2020 “Distribuidoras”. Result: Sanitary License + Technical Director Appointment Certificate.

Data verified against the official Catalogo Unico de Tramites del Estado (Service 3425 — MSPAS).

What This Procedure Is

The Dental Supply Sanitary License certifies that an establishment dedicated to importing, storing, distributing and wholesaling dental products complies with all sanitary requirements established in current technical standards. It is mandatory to open any dental supply business in Guatemala — without it, you cannot:

  • Legally import dental products
  • Distribute to clinics and dental practices
  • Register as a supplier with public or private hospitals
  • Operate under a commercial name recognized by DRCPFA

The license covers products such as: dental instruments, filling materials, dental prosthetics, dental laboratory equipment, dental local anesthetics, impression materials, dental X-ray equipment, dental chairs and more.

Who Needs It

  • Entrepreneurs opening a new dental supply business in Guatemala
  • Importers of dental products that wholesale to clinics
  • Distributors selling dental equipment and instruments to public/private hospitals
  • Dental laboratory companies that import materials and equipment
  • Branches or expansions of existing dental supply businesses (each location requires its own license)

If you only provide dental services as a clinic or practice (without product sales or distribution), you do not need this license — you need the Health Establishment Sanitary License.

Difference From Other DRCPFA Licenses

DRCPFA issues several sanitary licenses for different types of pharmaceutical establishments. Here is the key difference:

LicenseFor Which EstablishmentCostTime
Dental SupplyImport/distribution of dental productsFree60 days
PharmacyPublic sale of medicationsFree30 days
Drugstore / DistributorWholesale distribution of medicationsFree60 days
Medicine SalesRetail sale of medicationsFree30 days
Beauty SalonSalons, spas, beauty studiosFree60 days

Complete Requirements

Important: All requirements are defined in Technical Standard 48-2020 “Distribuidoras”. Download it from medicamentos.mspas.gob.gt before assembling the file.

Establishment Documents

  • Form F-AS-f-01 (Sanitary License Application for Pharmaceutical Establishments) — current version, properly filled out
  • Payment Slip V-CC-G-001 (current version)
  • Current commercial license (patente de comercio) of the establishment
  • NIT of the establishment (look up your CUI-NIT here)
  • Owner commercial license (if natural person)
  • Constitutional deed (if legal entity)
  • RTU SAT registration certificate

Technical Director Documents

  • Current DPI of the Technical Director
  • Professional title (dentist or pharmaceutical chemist)
  • Active professional college membership certificate
  • Acceptance letter for the Technical Director role
  • Curriculum vitae and employment certificate

Premises Documents

  • Location sketch (croquis) of the dental supply business
  • Architectural plan of the premises with storage areas, offices and dispatch
  • Habitability certificate or equivalent document
  • Lease contract or property title for the premises
  • Recent utility bill (electricity, water) as proof of address

Owner Documents

Step-by-Step Process

  1. Download official documentation from medicamentos.mspas.gob.gt:
    • Form F-AS-f-01
    • Payment Slip V-CC-G-001 (current version)
    • Technical Standard 48-2020 “Distribuidoras”
  2. Read Technical Standard 48-2020 carefully — it defines all installation, storage and operation requirements. Make sure your premises comply.
  3. Properly fill out Form F-AS-f-01 with establishment, owner and Technical Director data.
  4. Assemble the complete file with all required documents in the indicated order.
  5. Make corresponding payments for the procedure (although the main fee is Q0, there may be associated fees).
  6. Submit the Payment Slip to Window 63-A2 of MSPAS to generate receipt 63-A2.
  7. Submit the complete file to the Document Reception and Delivery Section of MSPAS.
  8. The Reception Section forwards the file to the Pharmaceutical Establishments Section (DRCPFA).
  9. The Pharmaceutical Establishments Section assistant receives, reviews and classifies the file.
  10. The assistant assigns the file to a Professional Evaluator for technical evaluation.
  11. The Professional Evaluator conducts the evaluation of the file. May request a site inspection.
  12. If the file complies, it is forwarded to the Digitizers to generate the Sanitary License and Technical Director Appointment Certificate.
  13. If the file does not comply, a rejection note with specific observations is issued. Address findings and re-submit the file.
  14. Pick up your Sanitary License and Technical Director Appointment Certificate at the corresponding section.

Cost and Time

ItemDetail
Official MSPAS costFree (Q0) — no direct fee
Official time60 business days from complete file submission
Validity1 year (annual renewal mandatory)
ModeIn-person at MSPAS (DRCPFA, Zone 11)

Associated costs (non-MSPAS): Technical Director fees, warehouse setup, equipment, notary costs for certificates, payments to professional colleges. These are not MSPAS fees but are unavoidable.

Common Mistakes & What to Do If Rejected

  • Not reading Technical Standard 48-2020 before applying — most rejections come because the premises do not meet installation requirements that are explicit in the standard.
  • Technical Director without active college membership — verify membership is current before including them in the file.
  • Warehouse without proper conditions — temperature, ventilation, separation between products, quarantine areas. Standard 48-2020 details what is required.
  • Incomplete form or inconsistent data — verify the F-AS-f-01 is filled out in clear handwriting or digital format, no empty fields.
  • Outdated Payment Slip version — the V-CC-G-001 slip changes. Always download the current version from medicamentos.mspas.gob.gt.
  • Products outside dental supply scope — if you want to sell general medications, you also need a Pharmacy or Distributor license.
  • If rejected, you will receive a note with specific observations. Address each point and re-submit the file with a copy of the original note — generally without needing to pay associated fees again.

The Dental Supply Sanitary License is governed by:

  • Technical Standard 48-2020 “Distribuidoras”: Defines all installation, storage, operation and technical personnel requirements.
  • Decreto 90-97 — Health Code, Art. 161-175: Establishes the obligation of sanitary license for distributors of pharmaceutical and related products.
  • Acuerdo Gubernativo 712-99: Current MSPAS Fee Schedule.