An Overview: India embarks on a transformative journey to streamline the approval process for drugs and medical devices, setting the stage for rapid innovation and improved healthcare access. With clear guidelines and proactive measures, the nation is poised to revolutionize the regulatory landscape, ensuring timely approval of life-saving treatments. Accelerating Access: India's Blueprint for Smoother Drug & Device Approvals! India unveils bold initiatives to expedite the approval process for pharmaceuticals and medical devices, signaling a new era of efficiency and collaboration in ..read more

Mandatory Registration of Class C and D Medical Devices Regarding the transition from mandatory registration to a licensing regime for Class C and D non-notified medical devices, effective from October 1, 2023, per GSR 102(E) dated February 11, 2020, under the Medical Devices Rules 2017: Manufacturers and importers are reminded of the forthcoming shift, wherein these devices will move from mandatory registration to a licensing framework. Under the Medical Devices Rules 2017, obtaining a manufacturing license for Class C and D medical devices necessitates an inspection within 60 days of a ..read more

Introduction: Uzbekistan, with its rich cultural heritage and burgeoning healthcare system, offers ample opportunities for medical device manufacturers to introduce their innovations. However, entering this market requires a thorough understanding of the regulatory landscape governing medical device registration. In this comprehensive guide, we delve into the intricacies of registering medical devices in Uzbekistan, providing valuable insights and actionable steps for manufacturers looking to navigate this process seamlessly. Understanding the Regulatory Framework: At the heart of Uzbeki ..read more

Introduction to Navigating Medical Device Software Validation and Verification Medical devices play a crucial role in diagnosis, treatment, and patient care. These devices often rely on sophisticated software to function effectively, making software validation and verification a critical aspect of ensuring their safety, reliability, and compliance with regulatory standards. In this article, we’ll explore the importance of validating and verifying medical device software and delve into the process’s integral to this crucial aspect of product development.  Read more about Global Regulat ..read more

Introduction: In the realm of healthcare, innovation often emerges at the intersection of different disciplines. One such area is the development of drug device combination products, which marry pharmaceuticals with medical devices to enhance therapeutic outcomes and patient experiences. However, bringing these products to market involves navigating a complex regulatory landscape that requires a thorough understanding of both pharmaceutical and medical device regulations.  In this blog, we delve into the intricacies of regulating drug device combination products and offer insights int ..read more

Performance Evaluation for IVD Device In vitro diagnostic (IVD) devices play a crucial role in modern healthcare by aiding in the diagnosis, monitoring, and management of various medical conditions. These devices encompass a wide range of tests and technologies, from simple blood glucose meters to complex molecular diagnostic assays. However, before these devices can be utilized in clinical practice, it is essential to conduct thorough performance evaluations to ensure their accuracy, reliability, and safety. In this blog post, we’ll delve into the intricacies of performance evaluation for ..read more

Overview - Global Opportunities for Medical Device Manufacturers In today’s era of healthcare innovation, regions like India, Latin America (LATAM), and Africa offer promising markets for medical device manufacturers. This blog delves into the opportunities and dynamics within these regions, providing valuable insights for manufacturers looking to expand their global presence. India: A Booming Healthcare Market India’s booming economy and large population offer lucrative opportunities for medical device manufacturers. The healthcare sector is experiencing substantial growth, fueled by ..read more

An Overview: In a landmark move aimed at advancing the integration of Artificial Intelligence (AI) into medical products, the U.S. Food and Drug Administration (FDA) has revealed a comprehensive document titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together”. This strategic blueprint delineates targeted priorities essential for harnessing AI’s potential across the medical product lifecycle. Central to the FDA’s vision is the commitment to ensuring the responsible and ethical utilization of AI in medical products, with a primary focus on en ..read more

Introduction to Cleanroom Setup for Medical Device Industry: In the medical device industry, ensuring the highest standards of cleanliness and product sterility is paramount to producing safe and effective products. This is where cleanrooms play a crucial role. Cleanrooms are controlled environments designed to eliminate airborne contaminants, providing an atmosphere for sterile setting for manufacturing medical devices. Setting up a cleanroom requires careful planning, adherence to regulations, and implementation of best practices. In this comprehensive guide, we’ll walk you through the e ..read more

CDSCO Circular - Online Submission of PSURs The CDSCO has issued a circular mandating the online submission of Periodic Safety Update Reports (PSURs) for Marketing Authorization (MA) of Medical Devices and In-vitro Devices. This measure, effective from March 19, 2024, aims to simplify the regulatory submission process for PSURs.  According to the circular, all applicants are now required to submit their PSURs through the Online System for Medical Devices portal and adhere to the provided checklist during submission. From April 1, 2024, offline submission facilities will be discontinue ..read more