Sponsor or manufacturer Name and address of the sponsor or manufacturer of the inves ...

CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies th ...

Post Marketing Clinical Investigation: Post marketing clinical investigation is the s ...

Additional elements, which may be required (a) Statement of foreseeable circumstance ...

agents, contractors and sub-contractors, and clinical investigation sites shall be op ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...