Explore the latest updates on Medical Device Rule in India. Our comprehensive guide covers the rules, compliance, and important insights. MedDev Experts
Navigating thru the regulatory panorama set thru the Central Drugs Standard Control Organization (CDSCO) may be a frightening challenge for pharmaceutical companies and manufacturers. However, facts and adhering to CDSCO tips are vital for ensuring the protection, efficacy, and great of pharmaceutical merchandise in India. Also Visit – Essential Documentation for Medical Device Import License […]
Navigating CDSCO Guidelines 2024 Read More »
Obtaining an MD 15 license is an important milestone for aspiring physicians within the United States. This license offers individuals the criminal authority to exercise medicine independently, supplying healthcare offerings to sufferers. However, obtaining this license includes assembly precise eligibility standards to ensure that only able and certified professionals enter the scientific area. Introduction to
MD 15 License Eligibility Criteria Read More »
Medical Equipment Manufacturing License in India under Medical Device Rule The Indian Medical Device Industry has witnessed significant growth and transformation over the years, and the demand for Medical Equipment has been on the rise. As a result, medical equipment manufacturing has become a crucial sector contributing to the healthcare ecosystem. However, to ensure the
Medical Equipment Manufacturing License in India under Medical Device Rule Read More »
Risk Management of Medical Devices in Accordance with ISO 14971:2019 This article is to assist manufacturers of medical devices to identify the hazards associated with the medical device, including software as a medical device, and in vitro diagnostic medical devices to estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of
Risk Management of Medical Devices in Accordance with ISO 14971:2019 Read More »
CDSCO Device Master File for Medical Devices The Device Master File for Medical Devices is a comprehensive and confidential document to provide technical information about the products to regulatory authorities. This document serves as a critical reference during the regulatory review process, enabling authorities to assess the safety, effectiveness, and quality of the medical devices
CDSCO Device Master File for Medical Device: Indian MDR 2017 Read More »
Essential Medical Device Symbols for Labeling: A Comprehensive Guide as per ISO 15223-1 Medical Device Symbols are essential for conveying vital information on medical devices. When deemed appropriate, symbols can be marked on the device, packaging, or associated documentation. Manufacturers must ensure the symbols are of a suitable size for clear legibility. Before implementing symbols,
Essential Medical Device Symbols for Labeling: A Comprehensive Guide As Per ISO 15223-1 Read More »
EU MDR Medical Device Labeling Requirements The EU MDR 2017/745, introduced by the European Parliament and the Council of the European Union in 2017, aims to enhance safety and quality standards for medical devices in the European Union. It replaces the older Medical Device Directives (EU MDD) and Active Implantable Medical Device Directives (AIMDD), bringing
Medical Device Labeling Requirements Read More »
Class C-D Medical Devices Under Licensing Regime from 01-10-2023 Introduction: Class C-D Medical Devices Under Licensing Regime The Ministry of Health and Family Welfare issued Notification No. GSR 102 (E) on February 11, 2020, introduced a transition period for licensing medical devices. According to the notification, a period of thirty months was provided for low-risk
Class C & D Medical Devices Under Licensing Regime from 01-10-2023 Read More »
Medical Device Import License by CDSCO: How to Get MD 15 License The Indian healthcare industry has experienced significant growth in recent years, with a market size of $190 billion in 2020. According to projections by the India Brand Equity Foundation, this industry is expected to reach $370 billion by 2024-2025. The driving force behind
Medical Device Park in Himachal Pradesh: Empowering the Future of Medical Device Manufacturing What is the Medical Device Park Scheme? In a move aligned with the Atmanirbhar Bharat initiative, the Ministry of Chemicals and Fertilizers has recently introduced the “Promotion of Medical Devices Parks” scheme. A substantial financial outlay of Rs. 400 crores have been
