Design and manufacturing information: 4.1 Device Design: The dossier should contain i ...

Information required to be submitted for the in vitro diagnostic medical device: (1) ...

22.0 Information required to be submitted for the in vitro diagnostic medical device: ...

4.0 Design and manufacturing information: 4.1 Device Design: The dossier should conta ...

Manufacturing processes: Central Drugs Standard Control Organization, Ministry of Hea ...

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

5. Sanitation: Availability of written specifications and procedures for cleaning the ...

Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) qu ...