Medical devices which are non notified such as condoms, surgical dressing, sutures, umbilical tapes, etc are regulated as “Drugs” which comes under Drugs and Cosmetics Act and Rules. These medical devices require the Registration Certificate in Form 41 and also, Import License in Form 10 to import to India. However, The Central Drugs Standard Control Organisation (CDSCO) has decided to regulate the medical devices in a phase wise manner to ensure safety, quality and performance .

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