AiMeD Hails CDSCO Medical Device Licensing Mandate but Flags Loophole for Foreign Certifications
New Delhi: The Association of Indian Medical Device Industry (AiMeD) has welcomed the recent CDSCO directive mandating Indian regulatory licenses for the procurement of medical devices. However, the industry body has also raised serious concerns that procurement agencies may still misuse the provision allowing additional requirements like USFDA or CE certifications, putting Indian manufacturers at a continued disadvantage.
Reacting to the circular, Rajiv Nath, Forum Coordinator of AiMeD, appreciated the government’s stance: "We welcome this assertion by Indian Regulatory Authority that basis of procurement in public health tenders needs to be CDSCO licensing, and buyers should not be seeking manufacturers to have overseas regulatory approvals of US FDA and CE , we do not need to be seeking international driving Liscense from Indians to drive in India."
However, Nath pointed out that the final line of the CDSCO communication dilutes the intent of the directive by permitting such foreign certifications as additional eligibility criteria.
He cautioned: "The last sentence—saying any other requirement should be above or over the requirement for a DCGI license. Which means it still allows hospitals and big buyers to specify CE / USFDA certification as a requirement along with the Indian license.
So it does not change the situation much for good Indian manufacturers."
Calling for corrective action, he added: "The last line needs to be expunged or edited. CDSCO can’t be authorizing other foreign certified approvals over and above its own."
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