New Delhi, April 13 -- India is revamping the regulations for its $12 billion medical devices sector, changing from a market-driven pricing model in favour of the country's first standardized fee structure for testing and certification.

The ministry of health and family welfare's plan aims to curb inconsistent market-driven testing costs by capping fees in government facilities to between Rs.150 and Rs.5,000, while at the same time easing market access for European-standard products, according to two government officials and documents reviewed by Mint.

While the move promises predictable compliance costs for small-scale manufacturers, it has sparked industry debate over new traceability mandates that some trade groups warn could constri...