India Medical Device Classification: Class A, B, C and D

1. Key takeaways

Indian medical devices are classified into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk), assessed against the parameters of Part 1 of the First Schedule of the Medical Devices Rules, 2017. Crucially, the power to classify rests with the Central Licensing Authority (CLA, that is CDSCO) — an enterprise cannot classify its own product into a final category. CDSCO official FAQ question 77 states expressly that only the Central Licensing Authority is the competent authority to classify under MDR 2017. Planning a filing around a self-assigned class is therefore structurally unsound: the class that governs the fee, the evidence depth and the route is the class the CLA accepts, not the class the manufacturer prefers.

• India uses four risk classes: A, B, C and D, defined in the First Schedule.
• Classification authority belongs to the CLA under Rule 3 and FAQ question 77.
• Products not on the published list require a separate classification request.
• The risk classification list is dynamic and can change at any time.
• Where classifications differ, the higher class may be applied.

2. Legal basis

The classification framework combines a fixed four-tier definition with a living published list and a documented procedure for products the list does not cover. The table below gathers the governing sources. Read together, they show that classification in India is a managed administrative act rather than a manufacturer’s declaration, and that the practical workflow must be built around the CLA’s position rather than around an internal conclusion.

3. Expert insights

Insight one: classifying the product yourself and then filing is the wrong sequence. The correct sequence is: first check the risk classification list published by CDSCO; if the product is found on it, prepare against that class; if it is not found, submit a classification request to the CLA first and enter the application only after the reply is received. Skipping this step places the classification judgement at the most expensive point of the project — if the CLA assigns a higher class than assumed, the depth of the DMF, the clinical evidence, the fees and the route all have to be redone. The rework is not limited to documents: timelines negotiated with distributors and launch plans anchored to a filing date unravel with it.

Insight two: the list is a living instrument. CDSCO has stated expressly that the list may be added to, removed from or amended at any time. This means a product filed as Class B three years ago may be moved up to Class C today. At renewal, or when adding a new model to an existing registration, the current list must be rechecked rather than the version relied on at the original filing. A compliance file that archives the old classification answer without re-verifying against the current list gives a false sense of security that collapses at the worst moment — during review of a change or a renewal.

Insight three: foreign classification is not determinative. A CE Class IIa designation or an FDA Class II clearance cannot be mapped directly onto an Indian Class B. CDSCO FAQ question 79 acknowledges that the classification system is aligned with existing global systems, but alignment is not equivalence; in practice, where they conflict, the higher class applies. European or American precedents are useful supporting material for a classification request, but they are evidence to be argued from, not answers that bind the Indian authority.

4. Practical recommendations

• Before any India project starts, GRZAN prepares a classification rationale document mapping the product’s intended use, duration of contact, invasiveness, implant status and active or non-active nature, item by item, to the parameters of the First Schedule.
• The document attaches the original labels and IFU and explains the product’s classification in the EU, the US and China, together with the reasons for any differences.
• It serves both as the internal determination record and as the working draft of a classification request to the CLA where the published list is silent.
• Classification, fees and route must be locked down together — the gap between the USD 50 fee for Class A and the USD 1,000 fee for Class B is a twenty-fold difference, and the evidence obligations move with the class as well.
• Re-verify the class against the current published list at every renewal and every new model addition, and record the verification date in the compliance file.

5. Verification checklist

• □ The product name and intended use have been searched in the CDSCO risk classification list.
• □ For products not on the list, the classification request documents for the CLA have been prepared.
• □ The list consulted has been confirmed as the current version.
• □ The differences from foreign classifications, and the reasons for them, have been documented.
• □ The classification conclusion has been carried into the fee estimate and the route selection.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 27 October 2026.