Medical Device Grouping in India: What Counts as a Distinct Device for Fees

1. Key takeaways

Import fees in India are levied along two dimensions: a fee for the overseas manufacturing site (one payment per site) plus a fee for each distinct device (one payment per device). What counts as one distinct device therefore directly determines the size of the official fee. The CDSCO checklist for Form MD-14 requires the applicant to state the product specifications, variants, accessories and the reasoning for the medical device grouping, and the grouping must be proposed consistently with the grouping principles CDSCO applies. This makes grouping a regulatory question with a price tag attached, not a commercial preference: the same physical product line can produce very different fee totals depending on how the family boundaries are drawn, and the grouping that is finally accepted must be defensible on technical grounds — shared intended use, shared design, shared manufacturing process — rather than chosen purely to minimise the per-device count. Because the grouping argument is written in the DMF and then asked again on the MD-14 checklist, any divergence between the two documents becomes an immediate and entirely avoidable source of deficiency queries, which is why the grouping decision belongs at the start of the project, in writing, in one place. The fee dimension also means grouping decisions should be made jointly by regulatory and commercial teams: the regulator reads the grouping as a technical claim, while the finance team reads the same grouping as a fee line, and only a single agreed table keeps both readings aligned throughout the project.

2. Legal basis

The table below sets out the fee structure, the MD-14 checklist requirements on grouping, and the fee entries that apply to ordinary devices and to IVDs at each class.

3. Expert insights

Insight one: the site fee is one-off; the device fee is a multiplier. A Class C/D project with three devices from one site costs 3,000 plus 3 × 1,500 = USD 7,500; with ten devices the total is USD 18,000. The number of devices is the dominant variable in the fee calculation, which is precisely why the grouping decision — the thing that decides how the range is counted — carries financial weight and deserves the same rigour as any other regulatory determination.

Insight two: the IVD per-device fee is low enough to be negligible. A Class A/B IVD costs USD 10 per device, against USD 1,000 per device for a Class B ordinary device — a difference of one hundred times. This explains why IVD manufacturers can economically roll out wide product lines in India, while ordinary device manufacturers must count their model numbers carefully and justify every addition to the range.

Insight three: the grouping reasoning must be written in the DMF and must match the checklist. Grouping is not a financial device; it is a technical assertion. A family needs common intended use, common design and common manufacturing process as its support. The reasoning is written into the DMF and asked again on the MD-14 checklist; inconsistency between the two places is a classic reason for rejection of the filing, and it arises purely from sloppy internal coordination.

Insight four: accessories and variants must also be declared. The MD-14 checklist explicitly asks about “variants and accessories”. Treating accessories as non-chargeable freebies and leaving them off the declaration may look like a saving at filing, but the omission will surface at later change applications and at customs clearance, when the paperwork and the goods no longer match. Declaring them costs the correct per-device treatment; omitting them costs credibility with the reviewer, and the second is far more expensive than the first.

4. Practical recommendations

• At the quotation stage, build a device list and grouping mapping table: map every model proposed for filing to the proposed group, and record for each group the common intended use, the common design and the common manufacturing process.
• Use this single table simultaneously for writing the DMF and for completing the MD-14 checklist, so that the official fee calculation and the technical documentation share one source of truth and the mismatch of “finance counting three devices while the technical file describes eight” cannot occur.
• Calculate the official fees as the site fee plus the per-device fee multiplied by the confirmed device count, on the correct class line item.
• For IVD projects, price against the IVD line items rather than the ordinary device line items, since the difference is structural, not marginal.
• Review the accessories and variants list against the product catalog before filing, so that nothing shipped is missing from the declaration.

5. Verification checklist

• □ All models, variants and accessories proposed for filing have been listed
• □ The grouping has been established with common intended use / design / manufacturing process stated
• □ The grouping mapping table has been used for both the DMF and the MD-14 checklist
• □ Official fees have been calculated as the site fee plus the device fee × quantity
• □ IVD projects have been priced on the IVD line items, not the ordinary device line items

Regulatory information verified as of October 27, 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