Conceptual map of Decree 4725 of 2005 (Articles 1 to 7): Specifications per article

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Se muestra una situación actual del parque Nacional de Guatemala
Camila Cardenas
Mind Map by Camila Cardenas, updated 5 months ago
Camila Cardenas
Created by Camila Cardenas over 3 years ago
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Conceptual map of Decree 4725 of 2005 (Articles 1 to 7): Specifications per article
  1. Article 1: Object and Scope
    1. Objective: To regulate the registration, marketing, and surveillance of medical devices for human use in the national territory. Scope: Natural or legal persons engaged in: Production Processing Packaging Packaging Storage Sale Use Importation Exportation Marketing Maintenance Exceptions: In vitro medical devices. Dental medical devices.
    2. Article 2: Definitions
      1. Medical device: Any instrument, apparatus, implement, material, or other similar article, used alone or in combination with others, to prevent, diagnose, treat, or alleviate a disease or ailment. Classification of medical devices: Class I: Low risk (examples: thermometers, bandages, gauze, syringes). Class II: Medium risk (examples: X-ray equipment, pacemakers, dental prostheses). Class III: High risk (examples: cochlear implants, heart valves, cardiac pacemakers). Other relevant terms: Manufacturer Importer Distributor Sale User Health surveillance
      2. Article 3: Classification of medical devices
        1. Classification criteria: Risk to user health. Purpose of the device. Mode of action. Degree of novelty. Invasiveness. Classification procedure: The manufacturer or importer requests classification from Invima. Invima evaluates the request and assigns the risk class.
        2. Article 4: Health registration
          1. Requirements to obtain health registration: Compliance with the technical-legal requirements established in the decree. Submit application to Invima. Pay the health registration fee. Required documents: Good Manufacturing Practices (GMP) Certificate. Laboratory analysis certificate. Labeling of the medical device. Instruction manual. Other documents that Invima considers necessary.
          2. Article 5: Marketing authorization
            1. Requirements to obtain marketing authorization: Have valid health registration. Compliance with good storage and distribution practices. Submit application to Invima. Pay the marketing authorization fee. Required documents: Health registration certificate. Good Storage Practices (GSP) Certificate. Good Distribution Practices (GDP) Certificate. Other documents that Invima considers necessary.
            2. Article 6: Health surveillance
              1. Health surveillance activities: Inspection, surveillance, and control of activities related to medical devices. Sampling. Laboratory analysis. Verification of compliance with technical-legal requirements. Surveillance measures: Warning. Fines. Suspension or cancellation of health registration or marketing authorization. Confiscation of medical devices
              2. Article 7: Sanctions
                1. Non-compliance with the decree: Fines. Suspension or cancellation of health registration or marketing authorization. Confiscation of medical devices. Temporary or definitive closure of the establishment. Disqualification from carrying out the activity.
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