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AIMED wants Centre to modify tender norms with ISO ICMED 13485 certifications so as to make bids non restrictive

Government departments like radiology, anesthesia, neonatology, paediatries, biochemistry, oxygen gas supply, biomedical waste etc. are favouring MNC companies over domestic players by adding US FDA restrictive clause specification for bids. The Association of Indian Medical Device Industry (AIMED) pointed out that all the tenders have discriminatory clause of quality certification requirements by USF DA and EU CE approved certification for equipment as well as for the reagents supply of hospital furniture, various medical equipment.


Rather than having a US FDA restrictive clause, we urge the government to consider amending technical specifications and add ISO 13485/CE/ICMED 13485 certifications along with US FDA as alternatives so that the bid can become non restrictive. If the requirement is for either one of the certifications, then manufacturers from across the globe will be free to participate in this tender, and not just the American manufacturers, opening up more competitive bids. Most importantly we urge the Centre to support the domestic industry by considering for all it’s tenders a 15 per cent price benefit for Indian origin goods, as done for world bank funded tenders under a buy Indian policy,” stressed Nath.

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