India
7 articles
IVD Registration Compared: FDA 809, EU IVDR, China, Brazil & India
Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.
India's Medical Device Market Decoded: 4,108 Manufacturers, 62% Imports
India's medical device market reached $20.98B in 2026 with 4,108 licensed manufacturers. Class A and B devices dominate at 76%, while imports supply 62% of market demand.
Asia-Pacific Medical Device Registration: Market Comparison and Entry Strategy (2026)
Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.
India Government Medical Device Procurement: GeM, Make in India, Reimbursement
Guide to India's medical device procurement channels, including GeM tenders, Make in India rules, CGHS and PM-JAY reimbursement, CDSCO/BIS requirements, and market access.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.
India BIS Certification for Medical Devices: Process, Standards, Costs, CDSCO
Guide to BIS certification for medical devices in India, covering required standards, ISI marking, testing, Manakonline, CDSCO overlap, timelines, and costs.
India CDSCO Medical Device Registration: The Complete Guide
How to register medical devices with India's CDSCO — MDR 2017 classification, import licensing, BIS requirements, clinical evidence, and practical market entry guidance.