Association Of Indian Medical Device Industry (AIMED) Recommendations
Who will the Indian National Medical Devices Regulator Regulate?
The currently proposed Regulatory Framework proposes CDSCO (& SLA) to continue to regulate the Manufacturer, CDSCO for the Importer and to delegate the Regulation of Trading Company to the State Licensing Authority. Our Proposal, in Line with the Japanese Regulatory System, is as follows The CDSCO should regulate the Importer, the Manufacturer (and the specific Manufacturer Site) and the Market Access Authorization Holder (whether the MAAH is the Manufacturer or Marketing Company or an Authorized Agent of the Overseas Manufacturer) and the SLA regulates the Domestic Reseller – Whole seller OR Retailer OR Healthcare Provider. Not considered, (Against Make in India)
What will be regulated to ensure patient safety?
Bu hikaye Bio Spectrum dergisinin November 2017 sayısından alınmıştır.
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Bu hikaye Bio Spectrum dergisinin November 2017 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
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