CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies th ...

Overall synopsis of the clinical investigation A summary or overview of the clinical ...

INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall c ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...

National Accreditation Body (1) The Central Government may, , by notification, design ...

Responsibilities of Sponsor: (i) The sponsor is responsible for implementing and main ...

(3) If on receipt of the application and the report referred to in sub-rule (2), the ...

. The applicant shall provide and maintain suitable equipment having regard to the na ...