Translated using machine translation service Hugo.lv
Vigilances system reporting of medical device accidents
The selected organisation: Zāļu valsts aģentūra
Short description:
The user of the medical device shall send the signal to the manufacturer or an authorised representative of the manufacturer and the distributor of the medical device, as well as to the State Agency of Medicines, within three days after the accident. The State Agency of Medicines shall compile, store, analyse reports on accidents with medical devices, propose or take appropriate measures for the specific category of accident.
Beneficiaries:
Any person
Duration:
Report within three days of the incident
Process description
Documents and forms
Other information
1. solis / Submission of a report
An accident with a medical device shall mean the unexpected operation or effects of any medical device by any manufacturer, as well as any inaccuracy in the label or instructions for use which, directly or indirectly, caused or could have caused the death of the device user or another person or a serious health disorder.

The user of any accident or potential accident device related to the use of a medical device shall notify the State Agency of Medicines within three days of the accident, as well as inform the manufacturer or the authorised representative of the manufacturer or distributor thereof.

Patients shall complete the form of the report: “Persons who use a medical device independently or according to the instructions of a medical practitioner, vigilances a system signal of an accident associated with a medical device” and sending it to an e-mail address: info@zva.gov.lv.

If the user of the medical device is a medical treatment institution, it shall complete the “Vigilances System Signal” and submit it to the website of the State Agency of Medicines at www.zva.gov.lv.

The service is free of charge.
Documents to be submitted
Payments: View payments
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working time
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details:
Working time
2. solis / Receipt of services
The applicant shall be informed in writing of the progress of the vigilance investigation and of the results thereof.
Payments: View payments