CDSCO Strict Risk Classification Directive for Medical Devices
In News
What Happened
Why It Matters
Background
History & Context
What Changed
- ▶
Risk Classification Verification: BEFORE, SLAs sometimes issued manufacturing licenses for Class A and B devices based on localized assessments or manufacturer claims without central verification. NOW, SLAs must strictly verify the device's classification against the dynamic official list maintained by the CLA before granting any license.
- ▶
Approval of Unlisted Devices: BEFORE, unclassified devices or new In Vitro Diagnostics (IVDs) were occasionally treated as default low-risk devices and granted local licenses. NOW, if a device is not on the official CDSCO classification list, applicants must formally obtain its risk classification from the CLA first.
- ▶
Investigational Medical Devices: BEFORE, localized approvals for investigational medical devices could sometimes bypass mandatory central oversight due to SLA regulatory lapses. NOW, prior CLA approval is explicitly enforced as mandatory for all investigational medical devices and new IVDs under Chapter VII of the MDR, 2017.
Prelims Angle
NCERT Connection
Practice Questions
Q1
With Reference ToWith reference to the regulation of Medical Devices in India under the Medical Devices Rules, 2017, consider the following statements: 1. The manufacturing licenses for Class A (low risk) and Class B (low-moderate risk) medical devices are issued by the State Licensing Authorities (SLAs). 2. The master risk classification list of all medical devices is maintained and dynamically updated by the Central Licensing Authority (CLA). 3. Valid international certifications such as USFDA or CE markings legally exempt a medical device from requiring a CDSCO or SLA license in India. Which of the statements given above is/are correct?