Medtech industry split over Centre's move on standard device testing fees

Medtech firms are split over draft norms on standardised testing fees, with some backing transparency and others warning of higher compliance burden for low-risk devices

The medical device manufacturing industry is divided over the recent draft notification by the Union Health Ministry that introduces a standardised fee structure for device testing and certification.

 

The draft notification amends the Medical Device Rules, 2017, introducing standard fees for 11 types of tests or examinations and mandates that the licence number of any third-party sterilisation facility be clearly visible on the device label.

 

While a section of companies has welcomed the move as a push towards transparency and traceability, others say that the step could lead to overburdening for low-risk device makers.

 

Urging more consultation, Rajiv Nath, forum coordinator of domestic medtech manufacturers’ lobby Association of Indian Medical Devices Industry (AiMeD), said that unilateral implementation of standard fees without consulting NABL-accredited labs risks unsustainable models for quality testing.

 

“With more than 6,000 devices under scope, controls must be risk-proportionate, rigorous for high- and moderate high-risk devices, and not overburden low- and moderate low-risk segments,” he added.

 

On the other hand, Himanshu Baid, managing director at Delhi-based Poly Medicure, said that the proposed standardised fee structure is a timely and progressive reform that brings clarity and predictability to the medical device ecosystem.

 

“By rationalising testing costs across said categories, it significantly eases compliance planning for micro, small and medium enterprises (MSMEs), enabling them to allocate resources more efficiently and focus on quality and innovation,” he added.

 

An industry executive told Business Standard that the move could open doors to a transparent and graded fee approach.

 

“Coupled with enhanced labelling norms for third-party sterilisation, the initiative promotes both affordability and regulatory discipline, especially benefiting emerging and small-scale manufacturers,” he added.

 

Nath, however, said that mandating licence numbers on product labels can create a significant barrier, delaying exports by three to four weeks during downtime at a gamma radiation subcontractor who provides specialised sterilisation, decontamination, and material modification services.

 

“We recommend limiting this mandate to shipping cartons and batch records for traceability and supply chain flexibility, as no global regulator imposes such restrictions. Also, there is a need to shift focus from low-risk to high-risk devices,” he added.

 

The draft notification is open to stakeholder comments and feedback till 30 days of its initial publication, that is, till May 10, 2026. However, Nath added that the absence of the draft from the Central Drugs Standard Control Organisation (CDSCO) website limits participation for device makers.