CDSCO, India's regulator, has published at least six documents on in-vitro diagnostics in 2026: two draft guidance documents, a new online classification route, an FAQ addendum and a final guidance on medical device software. Reading all of it, the main point is this: none of it changes the Medical Devices Rules, 2017 as they apply to IVDs. Each guidance document says so itself. What 2026 has produced is the most detailed account yet of how CDSCO reviews an IVD file, and that is useful for anyone about to submit one.
One thing that did change in the rules this year was widely reported as good news for novel devices. It does not apply to novel IVDs. That is the item most likely to mislead an IVD company planning for India, so we start with it.
The EU waiver in August does not cover a new IVD
What changed. The Medical Devices (Third Amendment) Rules, 2026 (G.S.R. 744(E), dated 14 August, published in the Gazette on 19 August 2026) inserted "or European Union countries" into rule 63. This rule lets CDSCO waive an Indian clinical investigation for a device with no Indian predicate if the device has been approved and marketed for at least two years in a listed country. We covered it in October.
Why it does not reach IVDs. India handles a new IVD (one with no CDSCO-approved equivalent) under a different rule, rule 64. The application goes on Form MD-28 and the permission is issued on MD-29. Rule 64 contains no reference-country proviso. The data required for a new IVD (Fourth Schedule, Part IV(b)) is "Clinical Performance Evaluation data carried out in India and in other countries (if any)". Unlike Part IV(a) for other devices, it has no line for claiming a waiver. G.S.R. 744(E) amended rules 19, 19H, 19J and 63 only. It did not touch rule 64.
So a CE-marked or FDA-cleared IVD with no Indian equivalent still needs CDSCO permission for a clinical performance evaluation in India (rule 59, Form MD-24) before it can be approved. The rule allows two exceptions. Class A new IVDs may not need clinical performance data. And for life-threatening or serious diseases, diseases of special relevance to India, emergencies, or conditions with no diagnostic available in India, CDSCO may abbreviate, defer or waive the clinical data.
Where a reference approval does help an IVD. If your IVD has an approved equivalent in India, rule 36(3) applies to it as it does to any other device. A free sale certificate from Australia, Canada, Japan, an EU country, the UK or the US means the import licence is granted without an Indian clinical investigation. Whether India counts as a reliance market for you therefore depends on one question: is your IVD "new" in India?
What CDSCO published in 2026, and its status
| Document | Date | Status at 19 October 2026 |
|---|---|---|
| Draft guidance for import of IVDs (CDSCO/IVD/GD/DRAFT/IMP/01/2026) | Dated 30 Jan; posted 2 Feb | Draft. The 15-day comment window closed in mid-February. No final has been published. |
| Risk classification module for IVDs on the online system (circular, 6 Feb) | Live from 2 Feb | In operation (administrative) |
| IVD FAQ addendum no. 2 (to CDSCO/IVD/FAQ/04/2022) | 13 Mar | Issued (administrative) |
| Guidance document on medical device software (CDSCO/MD/GD/MDSW/01/2026) | 21 Jul | Final. Covers IVD software. |
| Draft performance-evaluation protocols for scrub typhus IgM ELISA and rapid tests (ICMR–CDSCO) | 13 Jul | Draft. Comments closed 25 Aug. |
| Draft guidance for manufacturers of IVDs (CDSCO/IVD/GD/DRAFT/MFG/01/2026) | 9 Oct | Open for comment. 15 days from publication, so about 24 October. |
The import and manufacturing drafts each have two download links on CDSCO's site. Both links point to the same file. They are two documents, not four.
The import draft: what a foreign IVD maker will be measured against
The draft runs to 32 pages. It is written for the Indian importer, because in India the importer is the applicant and holds the licence (Form MD-14, granted on MD-15). The statutory clock for an MD-14 is 270 days (nine months in rule 36), and 30 days for an MD-16 test licence. The parts that matter most to a manufacturer are these:
- The documents have to match. Device names, model numbers, and the legal and actual manufacturing sites must agree across the power of attorney, the legal form and every free sale certificate. The draft lists common deficiencies. They include an EU free sale certificate naming only the legal manufacturer, model numbers that do not match the form, and a free sale certificate from China submitted as the reference certificate.
- The draft goes further than rule 36 on the reference certificate. It marks a free sale certificate from a reference country as required for every fresh application. It also lists as a deficiency a Singapore-made Class A product with no approval in any reference country. Rule 36(5) provides a route for Class A and B devices from other countries, using a country-of-origin certificate and published data. That is our reading of where the draft and the rule part ways. The draft is also inconsistent within itself: its checklist heading names five reference jurisdictions and leaves out the UK, while its text names six.
- Performance evaluation in India. For 20 disease areas the draft requires a performance evaluation report on three batches from a CDSCO-listed laboratory. The areas include HIV, hepatitis B and C, TB, malaria, dengue, cancer, ToRCH, sexually transmitted infections and "other life-threatening infections". CDSCO updated its laboratory list on 19 January and again on 29 June 2026.
- Fees. The fees are set by statute and are unchanged. For a Class C or D IVD, $3,000 per overseas site plus $500 per distinct IVD. For Class A or B, $1,000 per site plus $10 per IVD. The same amounts fall due as a retention fee every five years (Second Schedule). One quirk: the Schedule's retention line for a Class C or D overseas site is worded for devices other than IVDs. A draft amendment of 4 December 2025 (G.S.R. 883(E)) would correct this. That draft has not been finalised.
The manufacturing draft: for IVDs made in India
This 59-page draft is addressed to domestic manufacturers. It matters to a foreign company only if it plans to make IVDs in India, either itself or under a loan licence at another licensee's site. Two parts stand out. The first is a method for showing substantial equivalence to a CDSCO-approved predicate IVD: same intended use, same assay method, specimen and detection technology, and side-by-side analytical data including a method comparison on split patient samples. If no equivalent exists, the firm needs MD-25 and MD-29 permissions before applying to manufacture. The second is an explicit request that standalone software describe its algorithm, its AI model architecture and the trained model. The draft restates the statutory clocks (45 days for Class A/B, 105 for Class C/D) and the inspection rules.
A separate draft amendment to the Rules, G.S.R. 515(E) of 23 June 2026, would shorten several of those clocks. Its 30-day comment period has passed, and we found no final notification on CDSCO's index.
Software, including AI
The July software guidance applies to IVD software and says it "should not be misconstrued as a new regulatory control". In practice it shows how CDSCO will read an IVD software file. Software built into an analyser is part of that analyser. Software supplied separately that operates or influences an analyser is a distinct IVD with its own licence. Standalone software is classed on a three-by-three grid of the seriousness of the condition against what the output is used for. Software-as-a-service applicants are asked whether they host on a cloud empanelled by MeitY, the IT ministry.
For anyone shipping software updates often, the FAQ addendum of 13 March is the more important document. Its answer 21 says that every new version of approved software needs a post-approval change application. Neither the FAQ nor the July software guidance describes a route for pre-agreed updates of the kind some regulators now offer.
Who it affects
- Foreign makers of established IVDs (an Indian equivalent exists). Nothing in the rules has changed. Use the import draft as the reviewer's checklist. Most delays it describes come from documents that do not match each other.
- Makers of a genuinely new IVD, including most startups. Plan for an Indian clinical performance evaluation unless your test is Class A or fits the disease-relevance exception. The August EU change does not help you. You can file the evaluation application (MD-24) and the new-IVD application (MD-28) at the same time (FAQ answer 18). The statutory clock for MD-29 is 90 days plus up to 30, and both government fees are ₹25,000.
- IVD software and AI companies. Budget for a post-approval change on every release, and settle your classification early. If your product is not on a CDSCO list, the online classification route opened in February is the formal way to ask.
- Anyone with an Indian partner. The import licence belongs to the importer. A second importer of the same device needs its own licence, the "subsequent importer" route. When you choose a partner, you are choosing who holds your licence.
What our data shows
As at 19 October 2026, our Indian device corpus holds 53,955 imported-IVD product records under 2,204 import licences, the earliest dated 29 May 2018. It also holds 25,439 domestically made IVD product records under 975 manufacturing licences. Each record carries its Indian risk class:
| Class | Imported IVD records | Domestic IVD records |
|---|---|---|
| A | 5,552 (10%) | 5,133 (20%) |
| B | 33,992 (63%) | 16,084 (63%) |
| C | 13,217 (24%) | 3,062 (12%) |
| D | 1,133 (2%) | 1,126 (4%) |
Those import licences cover 792 manufacturer groups (by our company grouping; 799 records are not yet grouped) and 754 Indian importers. By the address on the licence, the largest origins are China (192 groups), the United States (128), Germany (75), South Korea (54) and Japan (45). 379 of the 792 groups (48%) have products imported by more than one Indian company, and 93 have five or more. That is the importer-held licence in practice: one manufacturer, several separate licences, each held by a different importer. Where a manufacturer is located does not tell you whether it holds a reference-country certificate. A maker based elsewhere may still hold one, and our data cannot show which do.
What to do
- By about 24 October: if you make or plan to make IVDs in India, comment on the manufacturing draft. The predicate-equivalence and software sections are where the detail is.
- Before any India filing: check whether your IVD has a CDSCO-approved equivalent. That one question decides whether India is a reliance market for you or a country where you run clinical work.
- Before choosing an Indian partner: agree in writing who holds the import licence and what happens to it if the relationship ends.
Classification lists are a separate question, and CDSCO publishes drafts there that read as though they were in force. For IVDs, the classification in force is the July 2021 list as updated on 25 October 2023. Nothing published in 2026 replaces it.
Sources: Medical Devices Rules, 2017, rules 36, 59, 63 and 64, Fourth Schedule Part IV and Second Schedule (CDSCO consolidated text); G.S.R. 744(E), 14 August 2026; G.S.R. 515(E), 23 June 2026; G.S.R. 883(E), 4 December 2025; and the six CDSCO documents in the table above, each read in full on 19 October 2026. This is regulatory intelligence, not regulatory advice. Check the current instrument before you file.