India Sets Standard Testing Fee Rules for Medical Devices

India has taken an important step to bring more clarity and consistency to its medical devices sector by introducing a standardised testing fee framework. The move is expected to make the system more transparent, predictable, and affordable for manufacturers.

The Ministry of Health and Family Welfare has proposed changes to the Medical Devices Rules, 2017, focusing on how testing and certification charges are set at government laboratories. Under the new plan, testing fees will range between ?150 and ?5,000. This replaces the earlier system where prices varied significantly, often creating confusion for companies and impacting medical device testing costs.

To keep pace with rising costs, the framework also proposes a 5% annual increase in fees. At the same time, the government has opened a 30-day window for public consultation, allowing industry stakeholders to share their views before the rules are finalised.

The initiative is part of a broader effort to strengthen India’s growing medtech industry and create a more predictable regulatory framework in India. The proposal also looks at aligning certain rules with global standards for medical devices, making it easier for internationally certified products to enter the market while ensuring local approvals remain in place.

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Another key focus is improving quality standards. The government plans to integrate Quality Management System (QMS) requirements into testing processes. In addition, testing facilities will be officially recognised as Government Medical Device Testing Laboratories, giving them a clearer role within the system.

The proposal also brings relief for manufacturers of low-risk devices such as stethoscopes, wheelchairs, and alcohol swabs. These products may follow a simpler online registration process, supporting ease of doing business in India and reducing compliance burdens.

Industry response has been mixed. While many see the move as a step toward transparent pricing in healthcare, some have raised concerns about implementation.

Overall, the new framework signals India’s push toward medical device regulation reforms and a more structured, globally aligned ecosystem that supports growth and innovation.