The Importance of Clinical Trials in the MedTech Industry
Clinical trials ensure safety, efficacy, and regulatory compliance for MedTech devices, driving innovation and market success in the healthcare industry. Why Clinical Trials Matter in MedTech 1. Ensuring Safety and Efficacy The primary goal of clinical trials is to confirm that a new medical device is safe and works as intended. Through a series of […]
CDSCO Manufacturing License for Medical Devices
CDSCO regulates medical devices in India. Companies must obtain a manufacturing license from CDSCO to legally manufacture devices and ensure regulatory compliance. What is the CDSCO Manufacturing License? The CDSCO Manufacturing License falls under the CLAA (Central Licensing Authority Approval) Scheme, granted by the State Licensing Authority and approved by the CLAA, provided the licensee […]
Quality Management System for Medical Devices in India
Introduction India’s medical device sector is one of the fastest-growing markets globally, with increasing demand for compliance with quality standards to ensure the safety and efficacy of products. A Quality Management System (QMS) forms the backbone of regulatory compliance, ensuring that medical devices meet the necessary standards throughout their lifecycle from design and development to […]
Test License Application for Medical Device Manufacturing
Before medical devices hit the market in India, manufacturers need a Test License for clinical testing. Bioexcel Lifesciences can guide you through the entire process seamlessly. Understanding the Test License: Forms MD-12 and MD-13 What is a Test License? A Test License is required for manufacturers who intend to produce medical devices for testing, validation, […]
CDSCO Medical Device Registration in India: A Complete Guide
The Central Drugs Standard Control Organization (CDSCO) governs the registration of medical devices in India. As the medical device industry grows, understanding the CDSCO process becomes essential. This blog provides a concise overview of the CDSCO registration process, its importance, and key steps involved. Understanding CDSCO and Its Role CDSCO, under the Ministry of Health […]
PMS Reports: Ensuring Ongoing Device Safety
Introduction: Post-Market Surveillance (PMS) is a crucial aspect of the medical device lifecycle, ensuring that devices remain safe and effective even after they have been released to the market. This blog will explore the key components and significance of PMS reports, accompanied by relevant images to enhance understanding. What is a Post-Market Surveillance (PMS) Report? […]
“EUDAMED Compliance: Navigating the New Era of Medical Device Regulation”
EUDAMED and its role in the EU Medical Device market EUDAMED, the European Database for Medical Devices, is a critical component of the European Union’s regulatory framework for medical devices. It serves as centralized hub for comprehensive information on medical devices available within the EU market. The primary role of the EUDAMED is to enhance […]
Streamlining Approvals: CDSCO Notice on NSWS Portal Implementation
Welcome to our latest update on the groundbreaking changes in regulatory processes. We are excited to share that the Central Drugs Standard Control Organization (CDSCO) has recently issued a notice, effective January 1, 2024, introducing the National Single Window System (NSWS) Portal. This development aims to revolutionize the approval processes for investors, promoting efficiency and […]
