28930680
Description
Mind Map by Camila Cardenas, updated 8 months ago
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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
- Article 1: Object and
Scope
- 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.
- 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.
- Article 2: Definitions
- 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
- 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
- Article 3: Classification of
medical devices
- 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.
- 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.
- Article 4: Health
registration
- 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.
- 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.
- Article 5: Marketing
authorization
- 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.
- 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.
- Article 6: Health
surveillance
- 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
- 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
- Article 7: Sanctions
- 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.
- 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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