Documents to be enclosed for new application for license to State/Central Licensing Authority
Documents to be included for renewal or transfer of license given under other existing laws prior to these Regulations
Licensing and registration of food business
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 […]
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 […]
Regulatory Guidelines for Labelling and Quality Assurance of Medical Devices in India
Introduction: In India, the Central Drugs Standard Control Organization, under the Ministry of Health and Family Welfare, has established comprehensive regulations for the labelling and quality assurance of medical devices. These guidelines aim to ensure the safety, identification, and proper usage of medical devices in the market. The following blog outlines key points from the […]
Regulatory Framework for Clinical Investigations of Medical Devices in India
Introduction: Clinical investigations play a crucial role in the development and evaluation of medical devices, ensuring their safety and efficacy before they reach the market. In India, the regulatory framework for conducting clinical investigations of investigational medical devices is outlined in detailed rules. This blog explores key aspects of these rules, shedding light on the […]
Navigating the Regulatory Landscape: Sales of Medical Devices in India
Introduction: The sale of medical devices is a critical aspect of the healthcare ecosystem, ensuring that innovative and safe technologies reach patients and healthcare providers. In India, the regulatory framework for the sale of medical devices is outlined in specific rules, providing guidelines for licensing, supply to hospitals, and recall procedures. In this article, we […]
Unveiling the Crucial Elements of Medical Device Registration in India
Introduction: Navigating the regulatory landscape for medical devices, whether in vitro diagnostic or other types, involves a meticulous process of documentation and adherence to essential principles. In India, the Central Drugs Standard Control Organization (CDSCO) has outlined a comprehensive set of requirements for device registration. This article explores the key elements that manufacturers and authorized […]
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 […]
