7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

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

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

PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR ...

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...