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India

4 articles

Reimbursement & Market Access

India Government Medical Device Procurement: GeM Platform, Make in India Policy, CGHS/PM-JAY Reimbursement & Market Access Guide (2026)

How India procures medical devices through government channels — GeM Government e-Marketplace platform, Make in India (MII) local content requirements, CGHS and PM-JAY reimbursement schemes, HLL Medical Services procurement, CDSCO and BIS registration, tendering procedures, and practical strategies for foreign manufacturers entering India's rapidly growing medical device market.

Regulatory

Medical Device Regulatory Consulting Hourly Rates by Region (2026)

Transparent benchmark of medical device regulatory consulting fees across 16 countries and regions — covering hourly rates by consultant tier, factors that drive cost, and how to budget for registration projects in the US, EU, Japan, Korea, China, India, Brazil, Saudi Arabia, and more.

Regulatory

India BIS Certification for Medical Devices (2026): Complete Process, Applicable Standards, Costs, Timelines & CDSCO Relationship

Everything you need to know about Bureau of Indian Standards (BIS) certification for medical devices in India in 2026 — including which devices require BIS, applicable IS standards, ISI mark, registration schemes for Indian and foreign manufacturers, Manakonline portal, testing in BIS-recognized labs, relationship with CDSCO, costs, timelines, and step-by-step guidance.

Regulatory

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.