Import of New drug/Investigational drug for clinical trials
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by […]
Regulation on Medical Device in India (Medical devices rules, 2017)
Ministry of health and family welfare on 31st January 2017 published the guidance regarding Medical devices. Regulation of Medical Device Classification of Medical devices: Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in […]
Manufacture of Medical Devices for sale or for distribution
According to the guidance provided by the CDSCO on Medical device manufacturing and distribution: Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make an application […]
Import of Medical Devices to Inida
The CDSCO has provided the guidance for importing medical device in India. It being stated in the guidance that: Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import […]
Navigating the Regulatory Landscape: Essential Documentation for Medical Device Licenses in India
Introduction: In the dynamic world of healthcare, the import, manufacture, and distribution of medical devices are subject to stringent regulations to ensure the safety and efficacy of these products. In India, the Central Drugs Standard Control Organization (CDSCO) has outlined specific requirements for the issuance of licenses for medical devices. This blog explores the crucial […]
Quality Management system at Marketing authorization holder organization
These topic comes under the guidance of Pharmacovigilance: Introduction: This module contains guidance for the establishment and maintenance of quality assured Pv system for MAHs for performing their Pv activities; MAHs shall establish and use quality systems that are adequate and effective for the performance of Pv activities. Structure and processes A Pv system is […]
Collection, Processing & Reporting of Individual Case Safety Reports
The guidance of pharmacovigilance for Marketing authorization holders in India has described the following points regarding collection, processing and reporting of ICSR (individual case safety reports) Under-reporting of AEs/ADRSs is a well-known problem associated with spontaneous reporting, therefore, MAHSs shall have different sources/methods to report AEs/ADRs to the organization. The following sources/methods required to be […]
Periodic Safety Update Report for Pharmacovigilance and safety monitoring
The Indian guidance regarding pharmacovigilance system has given description about the preperation and submission of periodic safety update reports. Introduction: The Periodic Safety Update Report is a document for evaluation of the benefit-risk profile of a pharmaceutical product submitted by the MAH at defined time points as per Drugs and Cosmetics Act, 1940 and Rules thereunder during […]
Pharmacovigilance System Master File for India
The Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products stated following thing regarding Pharmacovigilance System Master file PSMF. Content of PSMF Module 1 1.1 Introduction The CDSCO should make a regulatory decision regarding the safety and efficacy of pharmaceutical goods based on the expert committee’s analysis. The data that surface after the first […]
