What Changed in 2025 for Medical Device Regulation in India
2025 was a landmark year for India’s medical device regulatory landscape under CDSCO. Here is what every manufacturer and importer must know right now:
October 2025 — All Class C and D Devices Now Mandatory
Since October 1, 2023, all Class C and D devices must hold a valid CDSCO license. The 2025 enforcement cycle has now made this a hard compliance requirement — even devices that were previously “non-notified” must now be registered prior to import or sale.
Class A NSNM — Self-Notification Streamlined
Class A Non-Sterile, Non-Measuring devices can now self-notify on the SUGAM portal, obtaining an automatic registration number without a full CLA review. This dramatically speeds up market access for basic instruments and disposables.
New Risk Classification Module (November 2025)
CDSCO launched a new Risk Classification Module on the SUGAM portal, allowing manufacturers and importers to formally request device classification before submitting a full license application.
IVD In-Country Performance Evaluation (2025)
Class B–D IVDs from foreign manufacturers must now undergo In-Country Performance Evaluation in CDSCO-recognised Indian labs before import registration. This adds 3–9 months to IVD timelines and requires careful advance planning.
What This Means for Your Business
If your medical device was selling in India without formal registration before 2023/2025, you are now at immediate enforcement risk. DK Reg recommends a comprehensive classification assessment and retroactive compliance immediately.
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