The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical devices within the EU market. It is designed to facilitate easier tracking and identification of devices throughout their supply chain and use.
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Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's conformity to the regulations. It's essential for both pre-market and post-market compliance. This documentation must be readily accessible to regulatory authorities for inspection.
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A thorough description of the device, including its intended purpose, principles of operation, and specifications. Details about any variants or accessories should be included, as well as information on the technology and methodology used.
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It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). It's a comprehensive database designed to strengthen market surveillance and transparency in the medical device sector in Europe. Registration in EUDAMED is a critical step for manufacturers, authorized representatives, and other entities involved in the medical device lifecycle. Here's an in-depth look at the EUDAMED registration process and its implications
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The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical devices imported into India. In addition to setting drug standards, controlling the quality of imported medical devices, and coordinating the work of state drug control organizations, the CDSCO oversees the approval and regulation of all medical devices and clinical trials conducted in the nation. According to the updated CDSCO guidelines, Class C and D medical device imports may be suspended or canceled if an importer misses the deadline for obtaining a mandatory import license.
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Final notification GSR 777(E) was released by the Indian Ministry of Health and Family Welfare on October 14, 2022, formally exempting Class A non-measuring and non-sterile medical devices from the Import License (MD-15) procedure.
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The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare's Directorate General of Health Services division, manages medical device registration in India. India's National Regulatory Authority (NRA) is the CDSCO. Medical devices require close observation since they directly affect public health. To prevent miscommunication or inaccurate information among medical device entities, the regulatory body regulates not only the manufacture or import of devices but also other activities like labeling, packaging, and instructions for use.
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By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device markets worldwide is the Indian market. By 2025, its current valuation of $5.2 billion is anticipated to rise to $50 billion. In India, the Drugs and Cosmetics Act of 1940 governed devices; there were no particular regulations about medical devices. The Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India, were released by the Central Drug Standard Control Organization to close this gap.
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The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is partly driven by the regulatory changes introduced by the Central Drugs Standard Control Organization (CDSCO),
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What are the current audit timelines for medical device regulation, and how have they changed recently?
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Did you know that choosing the wrong Notified Body could delay your medical device’s entry into the EU market by months, if not years?
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