India Registration Fees under the Second Schedule: Device and IVD Rates

1. Key takeaways

The official fees for importing medical devices into India are set out in the Second Schedule of the Medical Devices Rules, 2017. They are levied along two dimensions — per overseas manufacturing site and per distinct device — and are legislated in US dollars. Conventional devices and IVDs sit in different rows of the schedule, and the rates differ enormously between them. The schedule also carries a manufacturing-side fee table, which is legislated in rupees, so any budget covering both import and local manufacture has to handle two currencies and two fee logics at once.

• Two-dimensional pricing: a site fee is paid once per overseas manufacturing site; a device fee is paid for each distinct device added to the licence.
• Different rows for devices and IVDs: the per-device rates for IVDs are far lower than for conventional devices of the same class.
• Retention fee equals the issuance fee: every 5 years the same amounts are payable again.
• Contingent items exist: overseas site inspection (US$6,000) and import testing (US$100 per device) are separate rows that apply only when triggered.

2. Legal basis

The import-side fees in the table below come from the Second Schedule of the MDR 2017, with the IVD rows sourced from the CDSCO import guidance for IVDs (the Rule 34(2) entries). Amounts are stated exactly as they appear in the source provisions.

Manufacturing-side fees (in rupees):

3. Expert insights

Insight 1: the per-device fee gap between IVDs and conventional devices is 100-fold. A Class B conventional device costs US$1,000 per device, while a Class A/B IVD costs US$10 per device. This is the most asymmetrical point in the Indian fee schedule, and it directly determines the expansion strategy for the two product lines in India. A diagnostics portfolio can be widened at almost negligible official cost per additional IVD, whereas each additional conventional device carries a substantial marginal fee that must be justified in the business case.

Insight 2: the site fee is the entry cost and the device fee is the marginal cost. First entry requires a site fee of US$2,000–3,000; each additional distinct device then adds US$1,000–1,500 for conventional devices. Multi-SKU product lines must be costed precisely, because the device fee multiplies with the number of distinct devices on the licence and can overtake the site fee in a wide portfolio.

Insight 3: the retention fee equals the issuance fee. It is payable every 5 years at the same amount as at first issuance. The real scale of the cost is therefore “first payment plus a repeat every 5 years”, not a one-time outlay. Budget models that record only the issuance fee understate the lifetime official cost of the licence, and the understatement grows with each 5-year cycle the product remains on the market. This is why the retention row belongs in every fee estimate from day one rather than being added when the first cycle falls due.

Insight 4: fees are legislated in dollars but collected in rupees. The Second Schedule legislates the import rows directly in US dollars, and payment is made in rupees converted at the prevailing exchange rate. Exchange-rate movement therefore causes a small drift in actual outlay, which is worth flagging in multi-year budgets rather than locking a single rupee figure into the plan.

4. Practical recommendations

• Build the official-fee estimate on a fixed six-row structure. GRZAN’s fee calculation sheet for clients always contains six rows: the site fee, the device fees (listed device by device), the overseas inspection fee (contingent), the retention fee (5-year milestone), the test licence fee (if applicable), and the clinical investigation / clinical performance evaluation fee (if applicable).
• Keep contingent items out of the fixed quotation. We do not merge contingent items into the fixed quote; they are listed separately so the client can see the boundary between certain expenditure and possible expenditure.
• Check the correct Second Schedule row before quoting. Conventional devices and IVDs sit in different rows, and applying the wrong row changes the estimate by an order of magnitude.
• Convert dollar amounts at the prevailing rate and state the rate used. Since payment is collected in rupees, the working figure depends on the conversion rate applied.
• Record the 5-year retention milestone in the long-term budget. The repeat payment is part of the true cost of holding the licence, not an afterthought.

5. Verification checklist

• □ The correct Second Schedule row has been selected for the product category (conventional vs IVD)
• □ The calculation follows “site fee + device fee × quantity”
• □ The retention fee is included in the long-term budget at the 5-year milestone
• □ The overseas inspection fee of US$6,000 is listed separately as a contingent item
• □ Dollar amounts have been converted into rupees at the prevailing rate

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