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Guatemala Medical Device Regulation

Guatemala Medical Device Regulation

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

Updated on 26/01/24

Regulatory Authority: Departamento de Regulación y Control de ProductosFarmacéuticos y Afines.

Link for Regulatory Authority: https://medicamentos.mspas.gob.gt/

Local Regulation: Technical Standard 37 Version 5-2016

Classification:

  • 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 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: [email protected]