This article is for founders, regulatory leads and marketing managers at Indian medical device and health tech companies. It assumes you hold, or are applying for, an approval from the Central Drugs Standard Control Organisation (CDSCO) and now have to write a website, run ads and prepare a sales deck for the product.
The question it answers is narrower than "what are the rules for advertising devices". It is this: once the product is approved, which sentences are you entitled to publish, and how do you stop the website, the sales team and the founder's LinkedIn posts from drifting beyond that?
We are a marketing team, not a regulatory consultancy. Treat this as a working method to take to your regulatory affairs adviser, and confirm the position for your device class before publishing.
"CDSCO registered" can mean several different documents
Founders use the phrase loosely. Under the Medical Devices Rules, 2017, what you hold depends on how the device reaches the market. The rules define a "licence" as one granted in Form MD-5, MD-6, MD-9, MD-10, MD-15, MD-17 or MD-19, and they also provide separate registration routes, including a chapter for Class A devices that are non-sterile and non-measuring.
Devices are placed in four risk classes: Class A (low risk), Class B (low moderate), Class C (moderate high) and Class D (high). The Central Licensing Authority classifies a device based on its intended use and the parameters in the First Schedule.
Before writing any claim, pull out three facts from your paperwork and keep them in one place:
- The exact document and form number you hold (licence, registration certificate or import licence).
- The device class on that document.
- The intended use statement as approved.
The third item matters most, because the rules tie it to your marketing.
Why promotional material is part of the regulatory definition
The Medical Devices Rules define "intended use" as the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use, or in promotional material relating to the device, "which is as per approval obtained from the Central Licensing Authority".
Read that as an operational rule. Your brochure, website and sales presentation are not outside the regulatory file. They are evidence of what you intend the device to be used for. If a web page implies a use that your approval does not cover, you have, in effect, described a new intended use without approval.
Two other provisions point the same way:
- The Fourth Schedule, which sets out the device master file for the submission dossier, lists labelling documents that include the product brochure and promotional material. The claims you submitted at the time of approval form a baseline, and a later brochure that says more than the one on file invites questions.
- Rule 44 prescribes the particulars of the label itself: device name, details needed to identify the device and its use, manufacturer's name and address, batch number, storage conditions, warnings, and licence number for the relevant route. The label and the website should not tell two stories.
CDSCO's own FAQ on the Medical Devices Rules is also worth reading, particularly its treatment of investigational devices. A licensed device that claims a new intended use, new population, new material or a major design change falls into the investigational category and is subject to the clinical investigation route. That is the route you would be inviting if your marketing outruns the approval.
Map each claim to its source
The most useful practical step is to stop treating copy as prose and treat each claim as an item that must trace back to a document.
| Claim type | Safe source | Common mistake |
|---|---|---|
| Device name, class, manufacturer | Licence or registration certificate | Using a trade name or variant not on the approval |
| What the device is for | Approved intended use, verbatim or narrower | Broadening to adjacent conditions or populations |
| Who may use it (clinician, trained user, lay person) | Approved intended user statement | Selling a professional device direct to consumers |
| Technical specifications | Instructions for use and test reports | Rounding a specification up |
| Accuracy or performance figures | Validation or clinical data on file | Quoting a study run on a different version |
| Clinical outcomes ("reduces", "improves") | Published evidence you can produce on request | Implied outcomes in headlines and testimonials |
| Comparisons with other devices or methods | Head-to-head data and legal review | Implying superiority by adjectives |
| Software features and AI | Version in the approval | Describing features in a later release |
The pattern is consistent. Narrower than the approval is usually safe. Equal to the approval is safe if you use the approved words. Broader is where the exposure sits.
A worked example (hypothetical)
Take an imaginary Class B pulse oximeter. Its approved intended use reads: "for spot-check measurement of oxygen saturation and pulse rate in adult patients at rest, by or under the direction of a healthcare professional".
| Draft line | Verdict | Why |
|---|---|---|
| "Spot-check oxygen saturation and pulse rate at the bedside." | Acceptable | Within the approved use and user |
| "Monitors oxygen levels all night to catch sleep apnoea." | Block | Continuous monitoring and a diagnostic purpose are not in the approval |
| "Suitable for newborns and children." | Block | Approved for adults only |
| "Clinically validated." | Hold | Needs a citation to the validation report, version and population |
| "Buy now for your family at home." | Hold | Approved for use by or under direction of a professional; check the user statement |
None of this is a legal opinion on the hypothetical device. It shows the method: each line is tested against the intended use, the intended user, the population and the evidence file.
