What changed in the 2026 classification update
The Central Drugs Standard Control Organisation (CDSCO) has issued revised Medical Device Classification Rules that significantly alter the regulatory pathway for several device categories. The update — effective from Q2 2026 — refines the four-class risk framework (A through D), introduces new sub-categories for in vitro diagnostic devices (IVDs), and formalises expedited review lanes for devices addressing unmet clinical needs in India.
The most consequential changes affect Class C and Class D devices, where the dossier requirements have been harmonised more closely with the Global Harmonization Task Force (GHTF) model. Additionally, the update introduces a dedicated IVD classification pathway that was previously handled through an ambiguous overlap between the Medical Devices Rules 2017 and the IVD Regulations.
Impact on registration timelines
For manufacturers currently in the submission pipeline, the revised rules introduce both opportunities and complications. Devices previously classified as Class B that now fall under the expanded Class C definition will need additional clinical data or performance evaluation reports. Conversely, some Class C devices with well-established predicates may qualify for the new “abridged review” pathway, potentially reducing approval timelines by 30–40%.
The new IVD classification tiers — ranging from IVD-A (self-testing, low risk) through IVD-D (high-risk screening for life-threatening conditions) — now align with the EU IVDR framework. This is a deliberate move toward mutual recognition and should simplify dossier preparation for manufacturers targeting both Indian and European markets simultaneously.
Dossier strategy implications
The updated classification rules demand a fresh look at your regulatory strategy if you are in any of these categories: combination devices (drug-device), AI/ML-enabled diagnostics, point-of-care testing devices, or any IVD targeting infectious disease screening. In each of these areas, the classification thresholds have shifted, and the data requirements with them.
LaborWissen recommends that manufacturers conduct a classification gap analysis against the 2026 rules immediately, even if a submission is already in progress. Early identification of classification shifts can prevent costly mid-review reclassification — which, under the new rules, triggers a mandatory 90-day extension of the review clock.
What to do now
Start with a classification mapping exercise: compare your device’s current classification against the 2026 rules. Identify whether your essential principles, clinical evidence, and labelling meet the updated tier requirements. If you are targeting both India and the EU, this is an excellent time to build a single dossier strategy that addresses both CDSCO and IVDR requirements in parallel.
For manufacturers who need guidance on the updated rules, LaborWissen offers a focused regulatory pathway review that maps your product against the new classification framework, identifies gaps, and provides a clear timeline to market.