Description and specification, including variants and accessories of the in vitro dia ...

(b) the intended user (lay person or professional); (c) a general description of the ...

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

Explanation : For the purpose of these rules, substances used for in vitro diagnosis ...

"notified" means notified in the Official Gazette by the Central Government, (zj) " ...

(C) devices notified from time to time under sub-clause (iv), of clause (b) of sectio ...

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...

1.2 Information regarding sterilization of the device (whether it is sterile or non-s ...