Navigating Medical Device Registration in Guatemala: Regulatory Insights & Market Projections

Regulatory Authority

Departamento de Regulación y Control de Productos Farmacéuticos y Afines.

Link for Regulatory Authority

https://medicamentos.mspas.gob.gt/

Local Regulation

Technical Standard 37 Version 5-2016

Classification of Medical Devices

• Class I: External Use – Non-Sterile 2.
• Class II: External Use – Sterile
• Class III: Internal Use – Non-Sterile
• Class IV: Internal Use – Sterile

Listing or Registration Requirements

The registration process starts in the country with the presentation of the Application Form for Sanitary Registration of Related Products.

The analyses performed by the National Health Laboratory (LNS) are carried out by market surveillance, this means that the Sanitary Registration Certificate is issued before the analyses are performed. This was clarified in the LNS-DRCPFA Communiqué 04-2022 on Tariffs for Medical Devices.

Class I is the only one that can be registered without analysis by the National Health Laboratory (LNS), classes II to IV require registration with physicochemical and microbiological analysis.

Documents Required for Guatemala Medical Device Registration

• Form signed by a Responsible Professional in Guatemala (Pharmaceutical Chemist). 2.
• Technical information of the product
• Specifications of the finished product
• Primary and secondary packaging projects
• Product description
• Certificate of analysis issued by the manufacturer
• Certificate of manufacturing guarantee (GMP, ISO, FDA) issued by health authority.
• Sealed samples (when applicable). All documentation must be submitted in original or notarized, and in Spanish language. If the documents are written in another language, a sworn translation into Spanish is required. In case of documents issued abroad, they must be sent in original and authenticated by Apostille.

Registration Timeline

Approximately 2-3 weeks

License Validity

5 years

Special Labelling Requirements

Labelling should be submitted in Spanish.

Who should make this Communication?

• Manufacturer

When to make this Communication?

Before placing a medical device into the market.

Market Overview

Projected to reach US$453.80 million in 2024, the Medical Devices market in Guatemala is set for substantial growth. Cardiology Devices take the lead as the largest segment, anticipating a market volume of US$68.95 million in 2024. A robust annual growth rate (CAGR 2024-2028) of 7.50% is foreseen, driving the market volume to an estimated US$606.00 million by 2028. 

In the global landscape, the United States is poised to contribute the most significant revenue, with an impressive US$182.00 billion expected in 2024.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk