CDSCO — The Central Drugs Standard Control Organization (CDSCO) has issued a new circular on 17 November 2025 that fundamentally reshapes how hospitals and public agencies procure medical devices in India. The message from the Drugs Controller General of India (DCGI) is unambiguous: Indian licenses under the Medical Devices Rules (MDR) 2017 are now the primary, mandatory requirement for procurement foreign approvals like USFDA and CE marks are no longer enough on their own.
CDSCO IMPORT LICENSE FOR MEDICAL DEVICES: WHAT HOSPITALS NOW EXPECT
- Indian MDR 2017 licensing is mandatory for procurement
Procurement agencies must ensure that every device they buy has a valid manufacturing or import license issued under the Medical Devices Rules, 2017, by either the State Licensing Authority (SLA) or CDSCO. - Risk-based classification confirmed
Devices continue to be regulated in India under four risk classes A, B, C and D with licensing responsibilities split between SLAs (for Class A & B manufacturing) and CDSCO (for all imports and Class C & D manufacturing).
- No sale without license
The circular reiterates that no medical device can legally be sold in India without an appropriate license from the relevant authority.
- USFDA/CE now clearly “add-on”, not replacement
Hospitals and agencies may still request USFDA, CE or other certifications, but strictly in addition to, and not instead of, CDSCO/SLA approval.
- Applies to all hospitals and health institutions
The instruction is addressed to the heads of institutes, organizations and hospitals, signaling that this is to be applied broadly across public and private institutional procurement.
HOW CDSCO RULES WILL CHANGE HOSPITAL MEDICAL DEVICE TENDERS IN INDIA
1. Indian License Is Your Ticket to the Indian Market
For both domestic and foreign manufacturers, a valid Indian license is now the gatekeeper for institutional business. Without:
- A manufacturing license (from SLA or CDSCO, depending on class), or
- An import license issued by CDSCO
your devices will simply not qualify for tenders or large procurement contracts—even if they hold prestigious foreign approvals.
2. Tenders Will be Rewritten Around MDR 2017
Manufacturers should expect changes in tender documents and hospital vendor registration forms, including:
- Mandatory submission of manufacturing/import license numbers and copies.
- Possible cross-checking of product names and model references against license details.
- Less emphasis on foreign marks as “must-have” criteria, and more on compliance with MDR 2017.
If your internal sales or regulatory teams have relied on USFDA/CE status as the main selling point in India, this strategy will need a swift update.
3. Heightened Pressure on Regulatory Readiness
The circular will likely accelerate regulatory activity:
- For unlicensed or partially licensed portfolios:
Manufacturers must prioritize obtaining or updating licenses for all SKUs that are being, or will be, marketed in India. - For pipeline products:
Launch timelines will need to reflect the time required for Indian licensing; commercial teams should not plan tenders around products that do not yet have licenses.
Regulatory and commercial planning now need to be tightly aligned—quoting a product without a valid license will put both the manufacturer and the procurement agency at risk.
4. Stronger Role for Indian Importers and Authorized Agents
Foreign manufacturers will need to ensure their Indian partners:
- Maintain up-to-date import licenses covering all relevant products.
- Can promptly provide license documentation for tender submissions.
- Have internal controls to ensure only licensed products are promoted and supplied.
Commercial relationships may need to be revisited to clearly allocate responsibilities for maintaining licenses and handling regulatory interactions with CDSCO and SLAs.
5. Competitive Landscape: Opportunity and Challenge
This shift may:
- Level the playing field for manufacturers who already invested in Indian licensing but previously lost out in tenders dominated by USFDA/CE-centric criteria.
- Challenge manufacturers who have relied solely on foreign approvals to access the Indian market without completing MDR 2017 licensing.
Those who act early to regularize their portfolios will be best placed to secure and expand institutional business.
CONCLUSION
CDSCO’s November 2025 circular sends a strong and simple signal to the industry: for medical devices in India, regulatory legitimacy begins with MDR 2017 licensing, not foreign certificates. Manufacturers that proactively align their documentation, product portfolios and tender strategies with this requirement will not only remain compliant but also gain a strategic advantage as procurement norms tighten.
Over the coming months, we can expect tenders and hospital procurement SOPs to increasingly echo the language of this circular—making Indian licenses the central passport to the country’s fast-growing medical device market.