CDSCO Streamlines Online Import Approval for Already Licensed Medical Devices & IVDs

The regulator has added a separate provision for ‘Subsequent Importer’ in the CDSCO online portal for importing devices and IVDs approved under the Medical Devices Rules, 2017.

The Central Drugs Standard Control Organization (CDSCO) has updated its online approval system to simplify the import process for medical devices and in vitro diagnostics (IVDs) already approved by the Central Licensing Authority (CLA).

The regulator has added a separate provision for ‘Subsequent Importer’ in the CDSCO online portal for importing devices and IVDs approved under the Medical Devices Rules, 2017.

Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), said, "The applicant who intends to import Medical Devices & IVDs which are already approved by the Central Licensing Authority for marketing in the country may submit their application for import of such devices as a subsequent importer as per the checklist provided for the said purpose."

This change aligns with CDSCO’s ongoing efforts to streamline regulatory approvals, increase transparency, and improve accountability. The organisation has published several ‘Tool Tips’ on its website to clarify technical requirements for applicants using the portal.

In addition, the procedure for ‘Brand Approval’ has been simplified and separated from routine endorsement applications, aiming to reduce processing timelines and facilitate faster approvals.

CDSCO has moved much of its operations online, including accepting applications and issuing approvals digitally. The regulator recently reported that approximately 97% of its operations are now digital, reducing inefficiencies by around 25%. Officials now have access to individual dashboards for real-time file tracking, enhancing transparency and aligning India’s regulatory processes with international standards.

The regulator has also introduced an online dual-use No Objection Certificate (NOC) system via the Sugam Portal for bulk imports of drugs for non-medicinal use, with NOCs valid for one year under prescribed conditions.

Earlier this year, CDSCO shifted acceptance of clinical trial applications for cell and gene therapeutics products (CGTP) from offline to online submission. Furthermore, applications for World Health Organization (WHO) Good Manufacturing Practices (GMP) and Certificate of Pharmaceutical Product (CoPP) are now mandated to be submitted solely through the Online National Drugs Licensing System (ONDLS). These steps form part of CDSCO’s broader initiative to digitise pharmaceutical regulatory procedures, streamline processes, and facilitate ease of doing business in the sector.

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