Based on the intended use and other parameters, the Medical devices (in vitro diagnostic and other than in vitro diagnostic) are classified into the following four groups by the Central Licensing Authority and the class wise lists are published in the website of CDSCO
- (i) Low risk – Class A
- (ii) Low moderate risk – Class B
- (iii) Moderate High risk – Class C
- (iv) High risk – Class D
The set of devices having similar uses of common technology may be grouped (Medical Device Grouping) by any person in accordance with the guidelines issued by the Central Government and they may apply for the grant of license for import, manufacture or sale. The medical device manufacturer should follow the essential principles of safety and performance as specified in the Guidelines issued by the Central Government. The medical device should conform to the standards specified in the BIS or as notified by the Central Government. If no relevant standards are available then they should conform to the standards specified in ISO, IEC (International Electro Technical Commission) or any other Pharmacopoeia. If no such standards are available then the device should conform to the validated manufacturer’s standards.