How to Get Medical Device Registration
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 group is a collection of two or more medical devices, supplied in a