Last Updated on January 29, 2025 by The Health Master
Class A and B
A recent Parliamentary Standing Committee report has emphasized the requirement of improving the coordination between the central and state governments for the licensing procedures and regulating the medical devices, especially for Class A and B medical devices.
Focus on States
The report highlights that while the Ministry of Chemicals and Fertilizers has mentioned the licensing process for Class C and D medical devices, clear guidelines and support are lacking for Class A and B medical devices.
These lower-risk medical devices fall under the purview of State License Authorities (SLAs), and the Committee has strongly recommended that the Ministry sensitize the states on the following:
- Streamlining License Procedures: SLAs must implement an efficient and transparent process for streamlining the licensing processes so that delays can be minimized while ensuring timely approvals regarding the class A and B medical devices.
- Best Practices: States should adopt and implement best practices in the regulation of medical devices and side by side align with the national guidelines and international standards.
- Addressing the Delays: The Committee also highlights the concerns about the delays in approval at state-level and also urges proactive measures to resolve these concerns.
Timely Licensing for All Classes
The report emphasized the importance of time-bound licensing for all classes of medical devices.
The Committee also highlights that the Ministry should ensure that all necessary measures must be taken into consideration so that licenses can be timely issued to the manufacturers.
Key Recommendations
- State-Level Capacity: All technical assistance must be provided, and all SLAs must be given training so that their capacity can be enhanced to effectively regulate medical devices.
- Data Sharing: Data must be shared, and collaboration must be there between the central government and SLAs. This is very important for effective oversight and regulatory harmonization.
- Regular Updates: The regular reviews of the licensing process must be done by the Ministry and update guidelines to address challenges and ensure continuous improvement.
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