7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

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

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

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

7.3.3 Design and development outputs: The outputs of design and development shall be ...

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

(vii) the registration holder shall inform forthwith, any change of existing expert ...