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...