AiMeD flags concerns over draft Medical Devices Rules amendments on testing fees, labelling

The Association of Indian Medical Device Industry has raised concerns over the Government of India’s draft notification proposing amendments to the Medical Devices Rules, 2017, particularly around capping of testing fees and new labelling requirements for sterilisation subcontractors.

The draft rules, published by the Ministry of Health and Family Welfare on April 10, 2026, introduce a Ninth Schedule that standardises fees for testing and evaluation of medical devices across categories. These include Rs 5,000 for implantation tests, Rs 2,000 for sterility tests, and Rs 1,000 for syringes and surgical dressings, with an automatic annual escalation of 5 per cent.

Industry flags sustainability concerns on fee caps

Responding to the proposal, AiMeD cautioned that unilateral capping of testing fees without consultation with NABL-accredited laboratories could undermine the sustainability of quality testing infrastructure.

“India has over 6,000 medical devices in scope. Any pricing control must be risk-proportionate—stringent for high and moderate high-risk devices, while avoiding unnecessary burden on low-risk segments,” said Rajiv Nath, Forum Coordinator, AiMeD.

The industry body also noted that the absence of the draft notification on the Central Drugs Standard Control Organisation website limits wider stakeholder participation and called for extended consultations with accredited labs and manufacturers.

Labelling clause may disrupt exports

AiMeD also flagged concerns over a proposed amendment to Rule 44, which mandates that medical device labels must include the licence number of outsourced sterilisation facilities.

According to the association, this requirement could create a “significant barrier” for manufacturers, particularly exporters.

“The mandate could delay exports by three to four weeks during downtime or changeovers at gamma radiation subcontractor facilities,” Nath said. “No global regulator imposes such restrictions at the product label level.”

AiMeD recommended that traceability requirements be limited to shipping cartons or batch records, rather than primary product labels, to ensure supply chain flexibility.

Call for balanced, risk-based regulation

The industry body further urged the government to ensure equitable applicability of rules across domestic manufacturers and importers, and to shift regulatory focus toward high-risk device categories rather than imposing blanket compliance requirements.

While acknowledging the intent to improve transparency and standardisation, AiMeD emphasised the need for a balanced regulatory approach, advocating for self-regulation, stakeholder consultation, and risk-based oversight.

The Ministry has invited objections and suggestions from stakeholders within 30 days of the draft’s publication, following which the rules will be finalised.