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Regulatory support in Guatemala
Cosmetics and related product registration in Guatemala
We support the registration of cosmetics, hygiene products, medical devices and other categories, with document review and dossier follow-up.
Before preparing the dossier
The product’s function determines the starting point
Intended use, composition and label claims help determine the category and applicable requirements. REFAR reviews this information and organizes technical and legal documents for submission to the Department for the Regulation and Control of Pharmaceutical and Related Products.
Service scope
Product categories we work with
Cosmetics
Products used to clean, perfume, protect or alter the appearance of body surfaces, such as creams, shampoos and makeup. We review the formula, restricted substances, labeling and manufacturer documents to prepare registration.
Hygiene products
Products used to clean, disinfect, deodorize or fragrance objects and surfaces. We review the declared use, composition, safety data sheet and label to organize the relevant documentation.
Hospital hygiene products
Hygiene products intended for hospital use, subject to specific requirements. We review the complete formula, specifications, safety data sheet and stability studies, and guide document preparation for applicable testing.
Medical devices
We assess proposed medical devices according to their description and intended use. We organize manufacturer certificates, quality information, labeling and applicable technical literature for registration.
Dental products
Products intended for dental use whose classification requires review of their function and characteristics. We help prepare specifications, quality documents, labeling and composition where applicable.
In vitro diagnostic reagents
Reagents for in vitro diagnostic tests, including their associated components. We review quality documentation, the Spanish package insert and identification of the calibrators, controls and solutions that make up the product.
Document review
What we check before submission
Identity and classification
Name, function, composition or technical description, origin and manufacturing or import arrangement.
Responsible parties
Manufacturer, registration holder, representative and distributors, with the relevant legal documents.
Quality and manufacturing
Certificates, specifications and manufacturer documentation according to category.
Formula and safety
Ingredients and safety data sheets for products that require them; consistency review.
Labels and package inserts
Product information, instructions, warnings and consistency between artwork and dossier.
Specific requirements
Stability, testing and associated components where required by the relevant category.
How we work
From assessment to follow-up
1. Assessment
We review the category and documents you have available.
2. Preparation
We identify gaps and organize forms, documents and artwork.
3. Submission
We check dossier consistency before submission.
4. Follow-up
We support the procedure and responses to observations from the authority.
Maintaining your authorization
Renewals and updates
We also assess renewals and changes to the registration holder, manufacturer, distributor, formulation or labeling. We define documentation and the procedure according to the category and requested amendment.
Getting started
Share what you already have
Send the product name and use, manufacturer, country of origin, formula or technical data sheet, and available labels. If already registered, include the certificate and the changes you wish to make.
Frequently asked questions
Before starting registration
Do all six product types have the same requirements?
No. Documentation varies by category. For example, hygiene products require a safety data sheet, while diagnostic reagents include information on associated components and a Spanish package insert.
Are hospital hygiene products processed like general-use products?
They should not be assumed equivalent. Hospital products have specific requirements, such as qualitative and quantitative formulas and stability studies. The current form also provides for approval of testing by the National Health Laboratory before the certificate is issued.
Do you manage registration of imported products?
Yes. We support registration of products manufactured abroad. We review manufacturer documents and requirements applicable to marketing them in Guatemala.
Does each presentation or variant need a separate registration?
It depends on the category and the changes involved. We assess presentations, formulas, shades, fragrances and components before determining whether grouping, an extension or a separate application is appropriate.
How long does the procedure take?
It depends on the category, available documentation, applicable testing and observations from the authority. After reviewing the case, we can organize a work plan; approval depends on the health authority’s evaluation.
Do I need all the documents before contacting you?
No. We can start with the technical data sheet, intended use and available labels to identify the category and prepare a list of missing documents.
Tell us which product you want to register
We will explain the category, initial documentation and next steps for your application in Guatemala.