Import of investigational medical device by Government hospital or statutory medical ...

For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

Equipment: (i) brief description of major production and quality control laboratorie ...

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

8.0 Specimen type: (a) This section should describe the different specimen types that ...

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

Illustration: Anticoagulant monitoring, diabetes management, and testing for C-reacti ...

10.0 Analytical sensitivity: This section should include information about the study ...