The Association of Indian Medical Device Industry has raised concerns over the government’s draft notification on medical device testing fees and labelling norms.

AiMeD’s Forum Coordinator Rajiv Nath said that capping testing fees without consulting National Accreditation Board for Testing and Calibration Laboratories-accredited labs could affect the sustainability of quality testing. He stressed that regulations should be based on risk, with stricter rules for high-risk devices and simpler norms for low-risk ones.

The association also pointed out that the draft was not available on the website of the Central Drugs Standard Control Organization, limiting wider stakeholder participation.

On labelling rules, AiMeD said requiring sterilization subcontractors’ license numbers on product labels could delay exports and disrupt supply chains. It suggested keeping such details in shipping documents instead.

AiMeD has called for consultations, transparency, and balanced regulation to support the medical device industry.