India Import versus Manufacturing Licence: Fee and Budget Comparison

1. Key takeaways

India operates two separate fee systems for import and local manufacturing. Import fees are legislated in US dollars (Class C/D site fee US$3,000); manufacturing fees are legislated in rupees (Class C/D site fee ₹50,000). The import path must additionally budget an overseas site inspection fee of US$6,000 (contingent), while the manufacturing path must budget notified body audit costs (which are not official fees). The official costs of the two paths are not in the same order of magnitude.

• Two currencies, two tables: the import rows of the Second Schedule are in dollars; the manufacturing rows are in rupees.
• Contingent vs contractual costs: the US$6,000 overseas inspection is contingent; the notified body audit on the manufacturing path is a market-priced cost outside the schedule.
• Timelines differ structurally: import decisions fall due within 9 months under Rule 36(1); manufacturing licences run on 140-day (Class B) and 105-day (Class C/D) periods.
• Official fees alone do not decide the path: the manufacturing route carries investment costs far beyond the schedule.

2. Legal basis

The comparison below places the two paths side by side, using the Second Schedule of the MDR 2017 for the fee rows and the relevant Rules for the statutory periods. All amounts are stated exactly as in the source provisions.

3. Expert insights

Insight 1: on official fees alone, manufacturing is far cheaper than importing. The Class C/D manufacturing site fee is ₹50,000, which at the prevailing exchange rate is far below the import site fee of US$3,000. The difference is not a rounding error — it is the kind of gap that makes a fee-based comparison look decisive on paper. Presented alone, this row of the table would suggest that manufacturing is obviously the cheaper route, which is precisely why the other rows must be read with it.

Insight 2: but the manufacturing path moves the cost from official fees to investment. Local manufacturing requires premises, equipment, personnel and a notified body audit. None of these appear in the Second Schedule, yet together they exceed the official-fee gap by a wide margin. The official fee comparison is only meaningful for companies that already have a plant in India. For everyone else, reading the two columns of the table as a like-for-like choice misrepresents what the manufacturing decision actually costs. A useful way to frame it internally is that the schedule prices only the regulator’s work, while the manufacturing decision prices an entire industrial undertaking on top of it.

Insight 3: the timeline is the real divide. Manufacturing runs on Class B 140 days and Class C/D 105 days, while import runs on 9 months. For categories where speed to market matters, the time advantage of local manufacturing may outweigh its cost disadvantage. The 9-month import clock is a statutory ceiling, not a service promise, so planning around it means planning for the full period. The manufacturing periods, by contrast, are short enough to support launch windows that the import path cannot match, and that difference compounds over every product generation.

Insight 4: the manufacturing path also carries a hidden benefit — it bypasses Rule 36(3). Rule 36 sits in the import chapter, and the six-item list constrains import. On the local manufacturing path, the clinical evidence requirement follows the independent logic of Chapter 7 (clinical investigation), which is a different threshold from Rule 36(3). Companies whose dossiers would struggle under the import-side evidence list should understand that the manufacturing route is assessed under a separate framework. This point is easy to miss because the fee table looks continuous across the two paths, while the evidence framework is not.

4. Practical recommendations

• Compare total cost of ownership, not official fees. When GRZAN advises clients on path selection, we do not compare official fees; we compare total cost of ownership: the import path equals official fees + contingent inspection fee + agent service fees + customs clearance costs; the manufacturing path equals official fees + amortised plant investment + notified body audit + local staffing.
• Carry both calculations to the same endpoint. Both paths should be costed up to the point where the first compliant product comes off the line, and only then compared.
• Import first to validate the market. For most Chinese companies entering India for the first time, the sequence we recommend is: import first (validate the market), then evaluate local manufacturing once sales are stable.
• Model the currency separately for each path. Dollar-based import fees and rupee-based manufacturing fees move with different variables, so the two estimates should not share one exchange-rate assumption. Keeping the conversions separate also makes the sensitivity of each path visible when the rate moves.
• Assess the Rule 36(3) exposure early. Whether the dossier is constrained by the import-side evidence list should be established before the path is chosen, not after.

5. Verification checklist

• □ Official fees for both paths have been estimated separately (watch the dollar/rupee units)
• □ Contingent items have been included (overseas inspection fee, notified body audit fee)
• □ Timelines have been compared (9 months vs 140/105 days)
• □ Whether the dossier is subject to Rule 36(3) has been assessed
• □ The decision has been made on total cost of ownership, not official fees

Regulatory information verified as of 27 October 2026.

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