Under G.S.R. 777(E) dated October 14, 2022, Class A (non-sterile and non-measuring) medical devices were exempted from licensing requirements, provided manufacturers or importers obtain registration numbers from CDSCO through the online medical device registration system.

The Directorate General of Health Services, under Rule 4(3) of the Medical Devices Rules, 2017, has issued the risk classification list identifying medical devices falling under Class A (non-sterile and non-measuring).
Key points include:

• The classification applies only to devices without measuring functions and not supplied in sterile form.
• Each device’s general intended use, provided in Appendix A, serves as a guideline for applicants registering under Chapter IIIB.
• The list remains dynamic and may be updated periodically by CDSCO based on product developments or regulatory needs.
• Devices with measuring functions or supplied in sterile condition will not qualify under this classification.