Medical Equipment Manufacturing License in India under Medical Device Rule

Leave a Comment / Regulatory Compliance Guide | By MedDev Experts, Medical Device Rule / By MedDev Experts

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 …

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Risk Management of Medical Devices in Accordance with ISO 14971:2019

Leave a Comment / Regulatory Compliance Guide | By MedDev Experts, CE Marking, Medical Device Rule, US FDA / By MedDev Experts

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 …

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CDSCO Device Master File for Medical Device: Indian MDR 2017

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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 …

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Essential Medical Device Symbols for Labeling: A Comprehensive Guide As Per ISO 15223-1

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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, …

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Medical Device Labeling Requirements

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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 …

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Class C & D Medical Devices Under Licensing Regime from 01-10-2023

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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 …

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Medical Device Import License by CDSCO: Complete Guide-Procedures, Requirements, and Regulations

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Medical Device Import License by CDSCO: How to Get Form MD 15 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 …

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Medical Device Park in Himachal Pradesh: Empowering the Future of Medical Device Manufacturing

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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 …

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How to get Medical Device Manufacturing license in India in 2023

1 Comment / Medical Device Rule / By MedDev Experts

How to get Medical Device Manufacturing License in India in 2023 Medical Device Manufacturing License in India Medical Device Rule, 2017 came into force to govern the import, manufacture, sale and distribution of Medical Devices including In-Vitro Diagnostic Devices in India. The Medical Device Rule is introduced to ensure medical devices’ safety, effectiveness, and quality …

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EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745

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EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745 Overview of Declaration of Conformity: The EU Declaration of Conformity is an official document through which the manufacturer confirms that the device meets the essential requirements mentioned in Annex IV of Regulation (EU) 2017/745 of the European Parliament and of the …

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