Dear all,
We hereby inform you that the Ministry of Public Health and Social Assistance of Guatemala, through the Department for Regulation and Control of Pharmaceutical and Related Products (DRCPFA), has published Version 03-2025 of the Technovigilance Notification Form (F-FV-c04), which details the information required for collecting data on the effectiveness of medical devices used in medical and surgical settings.
| DOCUMENT NAME | Technovigilance Notification Form |
| VERSION NUMBER: | 03-2025 |
| PUBLICATION DATE: | December 2025 |
| APPLICATION SUMMARY. | The key information required to submit this form is as follows:
1. Patient Information: · Name or initials · Sex · Age (in years) · Diagnosis or reason for device use
2. Information of the institution where the event occurred · Name of the establishment · Municipality and Department · Type of institution (Public or Private)
3. Device Information: · Generic name · Batch number · Brand · Model · Expiration date · Sanitary Registration Number · Place where the device was obtained or purchased (IGSS, Hospital, Pharmacy, other) · Name of the place where the device was obtained
4. Event description · Description of the adverse event or quality failure · Type of notification (Adverse event, quality failure, other) · Body area where the event occurred · Outcome (Recovered with sequelae, Required medical or surgical intervention, Life-threatening, Malformation, No harm, Unknown, Death (date))
5. Notifier Information · Full name · Email address · Phone number · Profession · Institution where they work · Date |
We appreciate your kind attention and, should you have any questions or comments, please do not hesitate to let us know.
Kind regards,