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In a fast-paced world where information shapes, our daily news service is your informed about the latest developments
CDSCO Launches Online Neutral Code Application for Manufacturing of Medical Devices
On February 12, 2024, the Central Drugs Standard Control Organization (CDSCO) of India issued a notice to the various stakeholders in the medical device industry, emphasizing the importance of submitting applications for Neutral Codes solely through the Online System of Medical Devices portal.
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CDSCO Launched National Single Window System (NSWS) Portal
On January 01, 2024, the notice was issued by the Central Drugs Standard Control Organization (CDSCO) of India to all stakeholders, announcing the establishment of the National Single Window System (NSWS). This system aims to streamline investor approvals and simplify business transactions by serving as a unified platform for obtaining approvals, licenses, registrations, and clearances as required.
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Navigating the Path to Obtaining a Medical Device Manufacturing License in India
Are you looking to venture into the medical device manufacturing industry in India? Understanding the regulatory landscape is crucial for success. Here's a concise guide on how to obtain a medical device manufacturing license in India. Firstly, classify your medical device according to its risk level, as per the Medical Device Rules, 2017. Classify it into Class A, B, C, or D based on factors like intended use and invasiveness.
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Dos and Don’ts for Medical Device Startups guided by ZYPS expert
Embarking on the journey of launching a medical device startup can be exhilarating yet challenging. Navigating the complex landscape of regulations, innovation, and market demands requires careful planning and execution. To help you steer your startup in the right direction, here are some essential dos and don’ts to consider.
Demystifying CDSCO Registration for Software as Medical Device (SaMD)
In the rapidly evolving landscape of healthcare technology, Software as Medical Device (SaMD) is gaining prominence for its potential to revolutionize patient care and clinical decision-making. However, bringing SaMD to market requires navigating regulatory frameworks to ensure safety, efficacy, and compliance. In India, the Central Drugs Standard Control Organization (CDSCO) oversees the registration and regulation of medical devices, including SaMD. Let's delve into the essentials of CDSCO registration for SaMD:
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Medical Device Regulatory Consulting – CDSCO Approval Process for Medical Devices
Navigating the regulatory landscape for medical devices in India can be daunting for manufacturers and developers. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for overseeing the approval and registration process for medical devices. For companies seeking to navigate this complex process, medical device regulatory consulting services offer invaluable expertise and guidance. Let's delve into the CDSCO approval process and the role of regulatory consulting in ensuring compliance and successful market entry for medical devices.
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