Medical Device Registration Consultant

  Medical Devices are the most found and used devices in day-to-day basis. Medical Device Rules, 2017 states the rules and regulations applied to medical devices in India. With a limited number of medical devices notified by the central government in India most of the medical device's requirement are met with the help of other foreign countries. The rules for Medical Device Registration in India are applicable on in –vitro diagnosis, surgical dressings, surgical procedures, insecticides , mechanical contraceptives, disinfectants and such devices notified under the Drugs and Cosmetics Act, 1940. ELT Corporate and its team helps our clients in all the issues and problems they face related to voluntary registration of medical dev ices in India .   Some medical devices in India are not yet approved by the Central Drugs Standard Control Organization ( herein after referred as ‘ CDSCO ’ ) . For implementation of such non-regulated medical devices, CDSCO has established a s...

  Step 1 -Classification of Medical Devices : Medical devices shall be classified on the basis of parameters specified in the First Schedule of MDR 2017, in the following classes, namely: 1.     A is a low-risk classification. 2.     Low to moderate risk-Class B; 3.     Moderate to high risk-Class C; 4.     High risk-Class D. Step 2: Grouping of the Medical Devices : An applicant  Grouping of Medical Devices having the same or similar intended uses or commonality of technology into a single application. Single: A Medical Device sold as a separate packaged entity that does not meet the family criteria . Family-A Medical Device family is a collection of medical devices, each medical device being a separate medical device. The Medical Devices comprise systems that are (i) from the same license holder; (ii) intended to be used in combination to complete a common intended purpose. Group : A Medical Device...