Medical Device Registration Consultant

  VOLUNTARY REGISTRATION OF MEDICAL DEVICES IN INDIA At present, India is at the stage of growing and expanding its domain in the industry of Medi ca l Devices in the country. Due to the limited regulated medical devices in the c ountry, India is at a challenging stage of establishing itself in the medical devices sector in the country. In past, India has faced a shortage of regulated medical devices in comparison to all the leading countries in the world, and hence, to overcome such situations in recent times India ha s focused and laid more emphasis on establishing, reforming, and implementing medical device rules and regulations in the country. In India, the Central Drugs Standard Control Organization is the regulating body for medical devices in the country.   ELT Corporate is one of the leading medical device registration   consultants in India at present who aims at delivering the best services to each and every person in I ndia in the field of medic...

  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...