Ficci seeks govt nod to restart import of pre-owned expensive medical equipment, ET HealthWorld
New Delhi: Industry has sought government approval to restart the import of certain pre-owned and refurbished high-end, high-value medical equipment. In a representation to the health ministry, industry chamber Ficci said healthcare providers are unable to access cost-effective medical equipment since such imports came to a halt in August.
As per the chamber, importer/refurbisher and end users could earlier import refurbished or pre-owned high-end, high-value medical equipment with a no objection certificate from the ministry of environment, forests & climate change but from August 15 they require drug regulator Central Drugs Standard Control Organization (CDSCO) registration.
CDSCO clarified that in the absence of provision to issue registration for refurbished medical equipment under the Medical Device Rules (MDR) 2017, they have stopped processing the applications previously submitted by importer/refurbisher, according to the Ficci representation, seen by ET. – Kirtika Suneja.
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