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NLEM Implants

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CDSCO    28 June 2018

The Central Drug Standard Control Organisation (CDSCO), had issued a notification wherein it proposed to include all implantable medical devices and other high-end equipment under the purview of the Drugs and Cosmetics Act, 1940. The list includes all implantable devices, CT scan equipment, MRI equipment, defibrillators, PET equipment, dialysis machine, X-ray machine, bone marrow cell separator etc.

Once these equipments are brought under the new act, it will be able to regulate the licences to manufacture, sell and import them. The Central Drugs Standard Control Organisation (CDSCO), has notified the list of devices to be regulated under the D&C Act and asked stakeholders to submit their suggestions by July 15.

Medical Electronics are not drugs and may misfit under Drugs & Cosmetics Act, so the government should enact a separate medical equipment act.

Implants can be long term implants (> 30days) or short-term implants (< 30 days > one hour) or even transient implants (< one hour). Short term applies to such devices as temporary implants and surgical instruments that come in contact with skin, bodily fluids, bone and tissue. The examples are joint replacement sizers and placeholders for implants, over-molded surgical blades, electrosurgical devices, catheters, shunts, diagnostic guidewires etc. Long term examples are tubing and drains, drug delivery systems, pacemakers, vaginal rings (IUD devices) and audiology applications.

Editors views: All medical equipment, reagents, drugs and devises should be sub classified in NLEM and non NLEM

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