Streamlining Medical Device Approvals in India
The Central Drugs Standard Control Organization (CDSCO) has launched the ‘National Single Window System (NSWS)’ site, which is a significant step in streamlining the process of obtaining medical device approvals in India. The federal government created this platform to serve as a one-stop shop for all investor-related clearances, making it easier to do business in the medical device sector.
Key Features of the NSWS Portal-
The NSWS portal works independently of the current SUGAM portal, providing a specialized platform for medical device approvals. The following three activities have been established in response to the 2017 medical device rule and are now LIVE on ‘NSWS portal’ effective from 01.01.2024.
- Form MD-01: Application for a grant of certificate of registration of a notified body
- Form MD-12: Application for a license to manufacture a medical device for clinical research, testing, evaluation, examination, demonstration, or training.
- Form MD-16: Application for license to import medical devices for clinical investigations, testing, evaluation, demonstration, or training.
More functionalities are expected to be added in the future.
Benefits for Stakeholders-
The launch of the ‘NSWS portal’ is expected to benefit various stakeholders in the medical device industry. In light of the foregoing, it is asked that all involved stakeholders submit applications for the mentioned three activities (i.e. MD-01, MD-12, MD- 16) through the ‘NSWS portal’ only, as the previous ‘cdscomdonline’ portal for the stated activities would be disabled from 15.01.2024.
Overall, the CDSCO’s ‘NSWS portal’ is a positive step towards creating a more efficient and transparent regulatory environment for medical devices in India. This initiative is expected to boost the medical device industry and contribute to improving healthcare outcomes for the country.
For more information, please reach out to https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTE=
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