Registering a New Medical Device in India with No Predicate: The Complete CDSCO Tutorial

If your medical device has no predicate in India, no device already approved there that yours is substantially equivalent to, then you are on the new-device pathway under the Medical Devices Rules, 2017 (MDR 2017), and the process runs differently from a routine registration. Different forms, a different licensing authority, an expert committee review, and a clinical data question that can add a trial to your timeline or, if you qualify for a waiver, remove one.

This tutorial walks the entire pathway from start to finish: how to confirm you are actually a new device, which forms apply at each stage and in what order, how the clinical data decision works under rule 63, what goes in the dossier, what the Subject Expert Committee does with it, and what happens after permission is granted, through to actually importing or manufacturing. It is written for regulatory and business teams who need to see the whole road before committing budgets, including overseas manufacturers evaluating India entry. Every form number in this article is the current one; a persistent source of confusion in this pathway is advice built on the wrong form map, and we will flag the common mix-ups as we go.

First, the map: the forms and who grants what

MDR 2017 runs on numbered forms, application and grant in pairs. The ones that matter for a no-predicate device:

Four orientation points before the steps.

The Central Licensing Authority, meaning CDSCO headquarters under the Drugs Controller General of India, owns the new-device decision. Whatever your device's risk class, a device with no predicate takes its market permission from the CLA through Form MD-26, and the permission arrives as Form MD-27. A recurring error in circulating advice is to label MD-22 as the new-device market application; it is the application for permission to conduct a clinical investigation, a different step for a different purpose. Building a project plan on that mix-up misorders the entire pathway.

The portals are split. Test licence applications go through the National Single Window System (nsws.gov.in). Everything else in the device lifecycle, clinical investigation permissions, market permission, import licences, manufacturing licences, runs through the CDSCO MD Online portal (cdscomdonline.gov.in). Older guides pointing to SUGAM are describing the drugs portal; CDSCO's own 2026 guidance states the split plainly, with test licences on NSWS and all other device applications on the MD Online portal.

The market permission alone does not put product on the market. MD-27 gives your device the right to exist on the Indian market; to actually place it there you still need the operational licence: an import licence (MD-14 to MD-15) for a device made abroad, or a manufacturing licence (MD-7 to MD-9 for Class C and D, state-level MD-3 to MD-5 for Class A and B) for one made in India. And before an import licence can even be filed, the Indian applicant must hold the state-level sale and distribution registration, Form MD-42, obtained on application MD-41. These dependencies set the critical path, so we sequence them explicitly in the steps below.

IVDs run a parallel fork. This tutorial walks the medical device arm; diagnostics mirror it with their own form pair, published side by side in CDSCO's 2026 medical device software guidance, which prints both pathways: a new in vitro diagnostic takes clinical performance evaluation permission via Form MD-24 (granted as MD-25) in place of the MD-22 clinical investigation, and its pre-commercialization market permission via Form MD-28 (granted as MD-29) in place of MD-26 and MD-27. Everything else in this tutorial, the test licences, the applicant structure and MD-41/MD-42 groundwork, and the manufacturing and import licence stage, applies to both arms.

Step 0: Confirm you are actually a new device, and classify it

"New" has a specific meaning here: no predicate device, meaning no device of the same intended use, material of construction, and design characteristics already holding an Indian licence. Two situations commonly surprise manufacturers. A device that is well established abroad, with FDA clearance and years of CE-marked sales, is still "new" in India if nothing equivalent is licensed there. And a truly novel combination, for example a hardware device whose software adds an AI-driven diagnostic function no licensed device performs, can be new even where its hardware elements resemble existing products, because the intended use differs. The definition also has a second limb that surprises existing licence holders: a device already licensed in India becomes an investigational device again when it claims a new intended use, a new population, a new material, or a major design change and is being assessed for safety, performance, or effectiveness. New claims on an old licence can put you back on this pathway.

Classification runs in parallel. India classifies devices into Class A (low risk) through Class D (high risk) under the First Schedule of MDR 2017, based on intended use. Classification determines your eventual manufacturing licence route and the depth of scrutiny throughout, so settle it first: check CDSCO's published classification lists, and where your device type does not appear or sits ambiguously, apply for a classification determination through the MD Online portal rather than assuming. For software and AI-enabled devices, classification and the surrounding documentation expectations are now governed by the final Guidance Document on Medical Device Software issued in July 2026, which we cover in a dedicated article; if your no-predicate device is software-driven, read that piece alongside this one.

Step 1: Establish the Indian applicant

A foreign manufacturer cannot apply directly. The applications are filed by an Indian entity: either an appointed authorized agent, or the manufacturer's own Indian subsidiary acting in that capacity, provided it holds the licences and registrations the role requires. As a practical matter, this entity needs the state-level MD-42 registration certificate for sale and distribution (applied for on Form MD-41) before the import licence stage, so incorporating or appointing early, and starting MD-41 early, keeps this off the critical path. The choice between an external agent and your own subsidiary is strategic as much as procedural: the applicant holds your licences, files your applications, and fronts your relationship with the regulator, so switching later is disruptive. Decide it deliberately at the start.

Step 2: The rule 63 question, the fork in the road

Rule 63 of MDR 2017 governs market permission for devices with no predicate, and it contains the pathway's most consequential fork: the clinical data question. The default expectation is that a new device proves itself through a clinical investigation conducted in India. The proviso to rule 63(1) then creates the waiver that changes everything for established products: the requirement to submit the results of a clinical investigation may be set aside where the device has been approved by the regulatory authority of the United Kingdom, United States, Australia, Canada, or Japan, and has been marketed in that country for at least two years, and the licensing authority is satisfied on the available safety and performance data.

Read the conditions precisely, because each word carries weight.

The list is exactly those five countries. European CE marking is not on it. A device with years of EU sales but no approval in a listed country does not qualify for the waiver today, a fact that routinely surprises European manufacturers. A change is pending: draft Medical Devices (Amendment) Rules published on 10 April 2026 propose adding European Union countries to the proviso. As of this writing the amendment remains a draft, its public comment period closed in May 2026, and no final notification has been issued. If it is notified, EU-approved devices with two years of EU marketing history would join the waiver route, a significant easing for European manufacturers. Until then, plan on the current list, and treat the amendment as upside. We will update this article when the notification lands.

Marketing history means two years in the approving country, with evidence: the approval itself, and documentation of actual marketing, typically supported by sales data and the device's post-market record (complaints, field actions, vigilance history). A fresh approval without marketing time does not qualify yet.

The waiver removes the pre-approval trial, and it does not remove Indian clinical evidence entirely. The MD-26 documentation includes an undertaking to conduct a post-market clinical investigation, so in waiver cases the Indian data obligation moves after approval rather than disappearing. Budget and plan for that study; it is a condition of the permission, and its design is worth as much care as a pre-market study would get.

One further nuance that trips up EU manufacturers specifically: the EU's absence from the rule 63 waiver list does not mean EU documents are worthless in the process. At the import licence stage, the Free Sale Certificate requirement accepts EU issuance. So an EU manufacturer may find its CE-based FSC accepted for MD-14 while the same EU approval does nothing for the clinical waiver. The two lists serve different purposes: one governs clinical evidence, the other import documentation, and each should be checked separately for your device.

Step 3A: The clinical investigation route (no waiver available)

If your device does not qualify for the waiver, the pathway runs through an Indian clinical investigation before market permission. The sequence:

Test licence first. To manufacture or import the investigational devices for the study, you need a test licence: Form MD-12 (grant MD-13) to manufacture test quantities in India, or Form MD-16 (grant MD-17) to import them. These applications go through the NSWS portal, unlike the rest of the pathway.

Clinical investigation permission. The study itself needs CLA permission, applied for on Form MD-22 and granted as MD-23, through the MD Online portal. The application carries the investigation plan: protocol, investigator's brochure, informed consent documents, site and investigator details, ethics committee approvals, compensation arrangements, and insurance. Clinical investigations follow the Seventh Schedule of MDR 2017, and registration on the Clinical Trials Registry of India is expected before enrolment.

Design realism. For a device new to India, the investigation's design is settled through review rather than copied from a formula: sample size, endpoints, and duration are expected to be proportionate to the risk class and claims. Where substantial foreign clinical data exists but the waiver is unavailable, a common and legitimate strategy is to propose an abridged local bridging study, presenting the global evidence as the core and the Indian study as confirmation in the local population. Whether that flies is decided in review, but a well-argued bridging proposal with strong global data behind it is taken seriously, and it is far cheaper than reflexively running a full pivotal program in India.

Then MD-26. With the investigation completed and reported, the market permission application (MD-26) is filed with the clinical investigation results as its centerpiece.

Step 3B: The waiver route

If your device holds a qualifying approval with two years' marketing, the pathway compresses: you file MD-26 directly, with the foreign approval and marketing evidence standing in for the Indian trial, and the post-market clinical investigation undertaking included. The application must still convince on safety and performance, so the global evidence package (clinical data, post-market surveillance history, literature) should be assembled to the same standard you would bring to any serious regulator, organized for an Indian reviewer who has not seen the product before. The argument that reviewer must be able to accept, named explicitly in CDSCO's checklist, is that there is no evidence or theoretical possibility of the device behaving or performing differently in the Indian population, so address population-sensitive performance factors directly rather than leaving the point implicit.

Step 4: The MD-26 dossier

Whichever route delivered you here, the market permission application carries the full technical story. The core contents:

• Device master file: description, intended use, design and specifications, materials, manufacturing process, and the risk management file
• Plant master file for the manufacturing site(s)
• Essential principles checklist: conformity with the essential principles of safety and performance under MDR 2017, the Indian counterpart of a GSPR table, with evidence references
• Verification and validation evidence: bench and performance testing, biocompatibility, electrical safety, sterilization validation as applicable, software verification and validation where relevant
• Clinical evidence: the Indian investigation results (route A) or the foreign approval, marketing history, and global clinical data (route B), plus the post-market clinical investigation undertaking
• Evidence that there is no theoretical basis to expect a difference in the device's behaviour or performance in the Indian population, a named item in CDSCO's own MD-26 checklist and the point on which waiver decisions turn
• Labels and instructions for use
• Regulatory status abroad: approvals, refusals, and withdrawals anywhere in the world, stated in full, because omissions here surface badly later
• For software and AI devices: the additional documentation the 2026 software guidance expects, including algorithm methodology, training and validation dataset composition with demographic coverage relevant to Indian use, and the Algorithm Change Protocol where the model will be updated

The dossier habit that pays off most is internal consistency: intended use worded identically across the application, labels, IFU, and clinical documents; device name and model numbers matching everywhere; classification rationale consistent with the claims. Indian review is document-precise, and small inconsistencies generate queries that cost weeks each.

Step 5: Subject Expert Committee review

New-device applications are evaluated with the input of a Subject Expert Committee (SEC), a panel of clinicians and domain experts for the relevant specialty. The SEC examines the technical and clinical evidence and gives its opinion: recommend permission, recommend against, or recommend permission subject to conditions, which for waiver-route devices typically includes the post-market clinical investigation, and can also mean recommending that a clinical investigation be conducted first, converting your route B into route A. Applicants may be called to present before the committee. Treat that hearing as the pivotal meeting of the entire pathway: bring the clinical lead who can answer evidence questions directly, prepare for the Indian-context questions (population applicability, healthcare setting fit, user training), and answer what is asked rather than presenting what was planned. The SEC's recommendation goes to the CLA, which issues the decision, and permission arrives as Form MD-27.

Step 6: From permission to product on the market

MD-27 in hand, the operational stage begins, and its sequencing depends on your manufacturing footprint.

Importing: the Indian applicant, already holding its MD-42 state registration, files Form MD-14 for the import licence, granted as MD-15. The checklist includes the Free Sale Certificate (EU-issued FSCs accepted), the MD-27 permission, quality certifications (ISO 13485), and labeling compliant with Indian requirements including Indian agent details. Typically, import licences for products with permissions already in place move on a scale of a few months, and the earlier MD-41/MD-42 groundwork is what keeps this stage short.

Manufacturing in India: Class C and D devices need the CLA manufacturing licence (MD-7 application, MD-9 licence) with its quality system and facility requirements; Class A and B run through the State Licensing Authority (MD-3 to MD-5). Manufacturers weighing import against local manufacture should note the incentives stacked on the domestic side, including production-linked incentive schemes and public procurement preference for domestically manufactured devices, against the customs duty cost of importing.

After launch, the obligations continue: post-market surveillance and vigilance reporting under MDR 2017, periodic safety reporting, the committed post-market clinical investigation for waiver-route devices, and change control, with any significant change to design, intended use, or manufacturing requiring prior approval. For AI devices, updates are managed against the Algorithm Change Protocol filed with the application.

The pathway at a glance

For a foreign manufacturer with a no-predicate device and no waiver: establish applicant and start MD-41 → classification confirmed → MD-16/MD-17 test licence via NSWS → MD-22/MD-23 clinical investigation permission → conduct study → MD-26 → SEC → MD-27 → MD-14/MD-15 import licence → launch, with post-market obligations running from day one.

With the waiver: establish applicant and start MD-41 → classification confirmed → MD-26 with foreign approval and marketing evidence plus post-market study undertaking → SEC → MD-27 → MD-14/MD-15 → launch, with the committed post-market investigation on the clock.

Common mistakes on this pathway

1. Building the plan around MD-22 as the market application, which misorders everything downstream. MD-22 is the clinical investigation permission; MD-26 is the market application.
2. Assuming CE marking qualifies for the rule 63 waiver. It does not today; the amendment that would change this remains a draft.
3. Discovering the MD-41/MD-42 prerequisite at import licence stage, adding months just when commercial pressure peaks.
4. Filing test licence applications on the wrong portal, or general applications on NSWS.
5. Treating the waiver as removing Indian clinical obligations entirely, then meeting the post-market clinical investigation undertaking unbudgeted.
6. Submitting a dossier whose intended use wording drifts between documents, generating query cycles.
7. For AI devices, arriving without dataset documentation or an Algorithm Change Protocol, both of which the 2026 software guidance expects.
8. Underestimating the SEC hearing, sending only regulatory staff to face clinical questions.

Frequently asked questions

How long does the whole pathway take? It depends on the route. The waiver route is typically measured in months from a complete MD-26 filing through SEC to MD-27, plus the import licence stage. The clinical investigation route adds the study itself, which dominates the calendar: permission, conduct, and reporting together commonly run one to two years or more depending on design. Query cycles are the main variable under your control on both routes, which is an argument for dossier quality over filing speed.

Can we run the Indian clinical investigation and the rest of the preparation in parallel? Substantially, yes. The MD-41 registration, quality documentation, labeling work, and dossier assembly can all progress during the study. The MD-26 filing waits only for the clinical report.

Does the two-year marketing clock have to be in one listed country? The proviso ties approval and marketing to the listed jurisdictions. A device approved in one listed country and marketed mainly elsewhere raises the kind of question the licensing authority weighs when deciding whether it is satisfied; present the marketing evidence for the approving jurisdiction as cleanly as possible.

Is the SEC step avoidable for simple devices? For no-predicate devices, expert evaluation is the design of the system, and the practical variable is preparation, not avoidance. Devices with strong, well-organized evidence and clear intended use statements move through with fewer conditions.

Our device is new but very low risk. Does it still go to the CLA? For devices in the licensing regime, the no-predicate market permission runs through the CLA regardless of class; class affects the manufacturing licence route and the proportionality of evidence, and it does not move the MD-26 decision to the state level. One carve-out applies at the bottom of the risk scale: Class A non-sterile, non-measuring devices sit in an exempted, registration-based regime, and clinical investigation is not mandatory for Class A devices, per CDSCO's published pathway. If your device is in that category, confirm its treatment before assuming the full new-device process applies.

What government fees apply? The fee schedule sits in the Second Schedule of MDR 2017 and varies by class, application type, and site count, and it changes by amendment. Check the current schedule on the MD Online portal at filing time rather than relying on any article's figures, including ours.

How EvySaif runs this pathway

EvySaif Research and Medical Affairs Solutions manages CDSCO new-device registrations end to end: regulatory strategy and classification, applicant structuring advice, rule 63 waiver assessments against the current list and the pending amendment, clinical investigation applications and regulatory management through the study, MD-26 dossier authoring, SEC preparation, and the import or manufacturing licence stage, alongside the EU, US, and MENA strategies for the same device. For software and AI devices we build the dossier to the final 2026 software guidance, including the AI documentation layer.

If you are scoping an India entry for a device with no predicate, write to info@evysaif.com or use the contact page, and we will map your fastest defensible route.

This article reflects the Medical Devices Rules, 2017 and CDSCO practice as of 12 August 2026, including the status of the draft Medical Devices (Amendment) Rules 2026. Requirements and fees change; verify against current CDSCO notifications before acting.