Is license required for class a medical device: what to know in 2026
In India, whether a Class A (low risk) medical device requires a formal license depends directly on its sterile and measuring status under the Medical Devices Rules (MDR) 2017:
Class A Non-Sterile & Non-Measuring: These devices do not require a full manufacturing license. Instead, they are subject to an online self-declaration registration process via the CDSCO portal, where basic device details and quality standards are submitted.
Class A Sterile or Measuring Devices: These do require a formal manufacturing license (Form MD-5) granted by the State Licensing Authority (SLA), along with ISO 13485 certification and technical audits.
Before manufacturing or importing, always review the official class a medical device list India published by CDSCO to confirm product categorization.
Navigating device classifications, testing protocols, and portal declarations can be complex. Consulting with experts at Regovex Consulting helps ensure complete regulatory compliance while streamlining your submission timeline.
In India, whether a Class A (low risk) medical device requires a formal license depends directly on its sterile and measuring status under the Medical Devices Rules (MDR) 2017:
Class A Non-Sterile & Non-Measuring: These devices do not require a full manufacturing license. Instead, they are subject to an online self-declaration registration process via the CDSCO portal, where basic device details and quality standards are submitted.
Class A Sterile or Measuring Devices: These do require a formal manufacturing license (Form MD-5) granted by the State Licensing Authority (SLA), along with ISO 13485 certification and technical audits.
Before manufacturing or importing, always review the official class a medical device list India published by CDSCO to confirm product categorization.
Navigating device classifications, testing protocols, and portal declarations can be complex. Consulting with experts at Regovex Consulting helps ensure complete regulatory compliance while streamlining your submission timeline.
Comments