Translated using machine translation service Hugo.lv
The adoption of the vigilance system reporting incidents of medical devices
The selected organisation: ZĀĻU VALSTS AĢENTŪRA
Short description:
State Agency of Medicines shall receive, compile, store, analyse reports of incidents with medical devices, proposed or taken appropriate measures in a particular accident category
Beneficiaries:
Any person
Maximum duration (days):
30
Process description
Documents and forms
Other information
1. solis / Service requests
Service may require onsite (customer service centre .kabinetā - 11), sending the necessary documentation by mail or e-mail.
The holder of the medical devices / authority shall transmit to the State Agency of Medicines signālziņojumu of the accident to the medical devices, which were prepared in accordance with the MK 2005. August 2 of Regulation No 581 "Medical device registration, conformity assessment, distribution, operational and technical arrangements for supervision of the" 24.
Medical devices manufacturer State Agency of Medicines shall be sent for medical devices for the start of the accident reports / report / report / end of an interim report of corrective actions / urgent security notice. The recommended form of the "Manufacturer’ s Incident Report ',' Report Form Field Safety Corrective Action", as well as "Urgent Field Safety Notice" available to the vigilance of the Medical Devices Guidelines' Guidelines on a medical devices vigilance system "(2.12-1 rev 6, the MedDev) drawn up by the European Commission Directorate - General for Industry and Entrepreneurship.
Documents to be submitted
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fakss: 67078428
Cita kontaktinformācija: Klientu apkalpošana 11. kabinets.
Darba laiki
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fakss: 67078428
Cita kontaktinformācija:
Darba laiki
2. solis / Receipt of services
The service is received in accordance with the application of choice.
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fakss: 67078428
Cita kontaktinformācija: Klientu apkalpošana 11. kabinets.
Darba laiki
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fakss: 67078428
Cita kontaktinformācija:
Darba laiki

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