India in a first sets fees for medical device testing and certification, moves away from market-driven mode

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 ₹150 and ₹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 constrict supply chains and delay exports.

Also, these fees will automatically increase by 5% annually, with the government to mandate the license number of any third-party sterilization facility to be clearly visible on the device label.

The health ministry has proposed amendments to the Medical Devices Rules, 2017.

The proposed amendment plans to add European Union countries to the list of recognized jurisdictions whose standards are accepted for registration. While this streamlines and harmonizes the process by acknowledging established global certifications, devices will still need to undergo the registration process with the Indian licensing authority.

Queries emailed to the health ministry spokesperson on Saturday remained unanswered till press time.

The government will be seeking public comments within a 30-day window to finalise these rules.

Furthermore, the government is enhancing quality standards for the laboratories themselves by incorporating Quality Management System (QMS) requirements into medical device rules to ensure that testing environments meet modern industrial standards. The rules also propose renaming testing facilities to Government Medical Device Testing laboratories to clarify their official status.

This comes as India plans to exempt low-risk medical devices including acoustic stethoscopes, wheelchairs, and alcohol swabs, from cumbersome licensing processes and replace it with online registration.

“For the first time, a comprehensive and standardized fee structure for medical device testing is being introduced nationwide,” said one of the two government officials cited above requesting anonymity. Previously, pricing was inconsistent as different laboratories charged varying rates; however, this notification ensures price uniformity across all of India. These fees apply to government laboratories and will have no impact on the Maximum Retail Price (MRP) of the devices, the official added.

There are mixed reactions from the medical device industry.

“The transparent and graded fee approach, coupled with enhanced labelling norms for third-party sterilization, will strengthen trust and traceability across the value chain,” said Himanshu Baid, managing director, Poly Medicure Ltd. By streamlining and standardizing testing costs, this reform increases affordability and regulatory clarity, allowing small-scale manufacturers to redirect resources toward innovation rather than unpredictable compliance expenses, he added.

However, some in the Indian medical device industry are not enthused by the government’s move.

Rajiv Nath, forum Coordinator of Association of Indian Manufacturers of Medical Devices (AiMeD), representing over 300 Indian medical device manufacturers said, “The new mandate to list sterilization subcontractor license numbers on product labels is a significant barrier that could delay exports by three to four weeks during subcontractor downtime.” He said that the regulatory focus should shift to high-risk devices, and questioned if these restrictions would apply equally to both domestic and imported products.