Medical Device Testing Officer and Medical Device Officer (1) The Central Government ...

Adverse events, adverse device effects and device deficiencies (a) Definitions of adv ...

Existing clinical data (a) Summary of relevant previous clinical experience with the ...

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

(iv) the person holding registration certificate shall maintain records of tests for ...

Paediatrics: (a) The timing of pediatric studies in the medical device development pr ...

the permission holder shall inform the date of launch of medical device in the marke ...

(ii) the applicant shall provide adequate space having regard to the nature and numbe ...