IVD Medical Devices in India: The Regulatory Divide

1. Key takeaways

In vitro diagnostic devices (IVDs) in India are likewise governed by the Medical Devices Rules, 2017, and the import route is the same as for ordinary devices (Form MD-14 → MD-15). The differences lie in four places: the fee schedule is different, a performance evaluation report (PER) must be submitted, clinical performance evaluation (CPE) of a new IVD must in principle be conducted in India, and a new IVD must first obtain a Form MD-29 permission. None of these four differences is visible from the application forms themselves, which is why IVD projects planned by analogy with ordinary devices discover the divergences late, when they are expensive to accommodate.

• IVDs follow MDR 2017 and the same MD-14 → MD-15 import route.
• IVD fees follow their own lines in the Second Schedule.
• A performance evaluation report covering three independent batches is required.
• Clinical performance evaluation for new Class B/C/D IVDs is done in India.
• New IVDs need prior permission under Rule 36(6) before any import licence.

2. Legal basis

The IVD-specific regime is assembled from the Rules, the fee schedule, the CDSCO IVD guidance and the CDSCO IVD FAQ. The table below collects the governing entries. Because the sources are spread across several documents, the most reliable way to plan an IVD project is to fix each of the four divergences to its source entry at the outset, rather than discovering them one deficiency letter at a time.

3. Expert insights

Insight one: IVDs are the same road under different rules. The forms and the process look identical to ordinary devices, but the pricing lines of the Second Schedule, the batch requirements of the PER and the localisation requirement of the CPE are all independent rules. Planning an IVD project with ordinary-device common sense produces failures at three separate points in sequence: first in the fee budget, then in the dossier structure, and finally in the timeline when the local evaluation requirement surfaces.

Insight two: question 68 is one of the most consequential findings in this series. For ordinary devices, a free sale certificate from the recognised jurisdictions can avoid an Indian clinical investigation (Rule 36(3)). For new IVDs this does not work — CDSCO has answered expressly that, whatever the regulatory status in those countries, the CPE of a new IVD must be done in India. This single answer raises the timeline and the cost of an IVD project by an order of magnitude, and it must be built into the business case before the project is committed, not after.

Insight three: the three-batch by three-raw-material-lot requirement looks simple and is the hardest to execute. It requires the manufacturer to have products made from three different lots of key raw materials produced and submitted for evaluation before the application — a front-loaded action at the production planning level, not a document assembly action. Manufacturing slots, raw material lots and stability considerations must be scheduled months ahead, and a delay in any one lot delays the entire application.

Insight four: the fee structure is remarkably favourable to multi-product IVD portfolios. A Class A/B IVD costs only USD 10 per device, against USD 1,000 per device for an ordinary Class B device — a hundred-fold difference. This means the expansion cost of an IVD product line sits mainly in the PER and the CPE, not in official fees, so portfolio strategy should be optimised around evaluation capacity rather than around fee arithmetic.

4. Practical recommendations

• GRZAN manages IVD projects separately from ordinary device projects, as a distinct workflow with its own gates.
• At initiation, the client must first answer three questions: is the product a new IVD (deciding whether MD-29 and CPE apply)?
• Is the target class C/D or A/B (deciding the depth of the PER and the fee lines)?
• Are products from three different lots of key raw materials already in production (deciding whether the project can start immediately)?
• Until these three questions have answers, GRZAN does not quote and does not schedule — because each unanswered question hides a timeline risk that no submission plan can absorb.

5. Verification checklist

• □ It has been determined whether the product is a new IVD (deciding whether MD-29 prior permission is needed).
• □ The class has been determined under the IVD classification guidance as Class A/B/C/D.
• □ Three independent batches, from three different lots of key raw materials, have been scheduled for production.
• □ It has been confirmed that CPE must be conducted in India (new Class B/C/D IVDs).
• □ Fees have been estimated against the IVD lines of the Second Schedule, not the ordinary device lines.

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.