India in a first sets fees for medical device testing and certification, moves away from market-driven mode
Mint·2h ago·Positivity
What Happened
India established standardized fees for medical device testing, replacing market-driven pricing with government-set rates between ₹150 and ₹5,000. The health ministry amended Medical Devices Rules 2017, adding European Union countries to recognized jurisdictions and implementing Quality Management System requirements. Fees will increase 5% annually. Low-risk devices like stethoscopes and wheelchairs face simplified registration. Industry response is mixed: some support transparency and affordability for manufacturers; others worry traceability mandates could delay exports.
Key Entities
India Health MinistryMedical Devices Rules 2017$12 billion medical devices sectorEuropean UnionPoly Medicure LtdAssociation of Indian Manufacturers of Medical Devices (AiMeD)Government Medical Device Testing Laboratories