Clinical trials - Bulgarian Drug Agency

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: Medical devices; 04 May 2017

Clinical trials

Notes on completing the Clinical Investigation Notification / Application Form

Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device

Application form to Ethics Committee for Significant Changes in Clinical Investigation of Medical Device and Documentation on art. 48 (1) of MDL

Notification form for Medical Device Clinical Investigation (art. 45 (2) of MDL)

Clinical Investigation Application form art. 45 (1) of MDL

Application form to BDA for significant changes in clinical Investigation and documentation on art. 50 (1) of MDL

Report form for incident/near incident in conduct of clinical investigation of medical device

SAE reporting form (MEDDEV 2.7/3)