09Oct Date October 9, 2025 Author Ms. Sneha RamasamyPost-Approval Changes in Medical Devices under CDSCOIntroduction Medical devices continue to evolve even after they receive regulatory approval. Manufacturers frequently implement i...
29Nov Date November 29, 2024 Author Ms. Sneha RamasamyWhat is a Free Sale Certificate (FSC)?An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
27Sep Date September 27, 2024 Author Ms. Sneha RamasamyNavigating the Regulatory Landscape for Innovative Medical Devices Without a Predicate in India: A Comprehensive GuideIndia's burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innova...
30Aug Date August 30, 2024 Author Ms. Sneha RamasamyUnveiling CDSCO Insights: Top 10 FAQs from My Professional JourneyQ: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelin...
26Apr Date April 26, 2024 Author Ms. Sneha RamasamyUnderstanding ISO 13485 and Notified BodiesUnderstanding ISO 13485 and Notified Bodies ISO 13485:2016: The internationally recognized standard for quality management sys...