# Is a Shirodhara machine a medical device? > Usually it is sold as general wellness equipment rather than as a medical device, and that position depends on the purpose its manufacturer states rather than on what the machine is. In India and the EU a claim to treat a named condition brings a product inside medical device regulation; in the United States it removes the FDA's general wellness forbearance. Nothing here is outside regulation altogether: product safety, electrical and advertising law still apply. **Disclosure.** Age Ayurveda, which publishes this site, sells the [Surya Shirodhara](/shirodhara/choosing-equipment/), a gravity vessel. The section below on gravity devices is about the kind of product we sell, and the regulatory point in it happens to favour us. Read it knowing that. Two questions come up before anyone buys a Shirodhara apparatus: which one to get, answered in the [equipment comparison](/shirodhara/choosing-equipment/), and whether the thing is a medical device. The second is misunderstood in both directions, by sellers implying a medical grade they do not have and by buyers assuming any therapy apparatus must be licensed. ## What decides it **Not the motor, the temperature controller or the price. The purpose the manufacturer states.** A gravity vessel and a fully automatic oscillating machine sit in the same position while both are presented as wellness equipment. State a medical purpose for either and it becomes a device with a medical purpose, with everything that follows. This is why the wording on a product page is not marketing decoration. It is the boundary itself. ## Where each market stands **India.** CDSCO publishes no classification for Shirodhara or other Panchakarma apparatus. That absence is not the whole answer, because notification S.O. 648(E), in effect since 1 April 2020, made the Medical Device Rules apply by intended purpose rather than by membership of a notified list. What follows from that is conditional: registration and licensing attach once a medical purpose is stated, and equipment sold with none is not a medical device, so nothing under those Rules reaches it. There is no AYUSH standard for such equipment either, which is worth knowing if you are buying on the assumption that someone has set a quality bar. **United States.** A device like this would generally fall within the FDA's general wellness policy. Two things about that policy are commonly misread. It is enforcement discretion, a statement that the FDA does not intend to enforce device requirements, rather than a finding that the product is not a device. And it has two limbs: the product needs a general wellness purpose **and** to be low risk. The guidance was revised in January 2026, so read the current text rather than a summary of the old one. **European Union.** Article 2(1) of the Medical Device Regulation defines a device by the purpose **its manufacturer** intends, and Article 2(12) reads that purpose off the labelling, the instructions and the promotional material. A reseller does not reclassify someone else's product, but a reseller who advertises a medical purpose is placing a medical device on the market under their own claim, and takes on the manufacturer's obligations themselves. One qualification: Annex XVI brings six named product groups inside the Regulation with no medical purpose at all. A dhara vessel is not among them, so the conclusion holds here, but "no medical claim means outside the MDR" is not a general rule. ## The oils are a separate question The apparatus and what you pour through it are regulated differently. A medicated taila is an Ayurvedic drug: in India, manufacturing it for sale needs a licence in **Form 25-D** from the **State Licensing Authority**, under **Schedule T** good manufacturing practice, which carries its own certificate. Contract manufacture runs on a loan licence, Form 25-E, which is how a good deal of Ayurvedic oil is actually made. "An AYUSH licence" is trade shorthand for this. A session run on plain sesame or coconut oil, which is what many spa versions use, involves no Ayurvedic drug at all. ## What "not a medical device" does not mean It does not mean unregulated. Outside medical device law a Shirodhara apparatus still sits under general product safety, electrical and advertising rules. In the EU that means the Low Voltage Directive and the EMC rules for a mains product, with the General Product Safety Regulation covering a purely mechanical one and anything the sector rules do not reach. In India it means BIS requirements where a Quality Control Order covers the category. In the United States it means consumer product safety oversight, and the FTC's requirement that any claim be substantiated. Risk is not confined to powered units either. Any Shirodhara device pours heated oil onto a supine person, so the FDA's low-risk limb is not automatic for either type: a powered unit's heater is one pathway, and a vessel with no thermostat leaves the temperature entirely to the operator. ## What to ask a seller **Treat a therapeutic claim as a flag rather than a reassurance.** A vendor advertising relief from a named condition has taken on obligations their regulator will hold them to, and the published evidence does not establish efficacy for a named condition: the trials are few and small. One 2025 meta-analysis of randomised trials reported a statistically significant reduction in diastolic blood pressure whose authors describe it as of low clinical value, with the systolic result unclear (PubMed 40104342). That is a long way from a treatment claim. **Ask what is actually certified, and in what.** On a powered device the meaningful evidence is electrical, and it has names you can check: - A **CB Test Certificate and report** against the relevant IEC standard, naming the issuing national certification body. There is no such thing as an "IEC mark", so a seller offering one is describing something that does not exist. - For India, **which Indian Standard applies, and the registration or licence number with the scheme that issued it**. "BIS certified" on its own is not checkable. - For Europe, CE marking for electromagnetic compatibility, and for low voltage only where the product's own voltage is in scope. A 12 V appliance fed by a mains transformer is itself below that threshold; the transformer is the part in scope. "Medical grade", used of a Shirodhara machine, has no defined meaning in any of these frameworks. ## The gravity case, and what it costs A gravity device has no electrical compliance surface: no transformer to certify, nothing in scope for the EMC or low voltage rules. That removes one compliance file, which is a real and checkable difference for anyone selling across borders. It does not remove the obligation: general product safety law, importer and responsible-person duties and advertising rules apply to a mechanical vessel exactly as they do to a powered one. It costs three things, and they are worth stating in the same breath. It holds no set temperature, so the oil cools through a session unless someone intervenes, and every powered machine in the comparison table holds temperature better than ours does. There is no timer and no oscillation. And there is nothing third-party to check: the certificates named above are a buyer's independent evidence on a powered unit, and a gravity vessel has no equivalent, so you are relying on the maker rather than on a test house. What it buys, for the buyer that suits, is a device that works with no power at all, which matters where supply is unreliable or a room has no fit-out, and an apparatus closer to the classical dhara patra than any powered machine is. ## The limits of this page This is a reference summary for people choosing equipment, not legal or regulatory advice, and the rules move: the US guidance changed in January 2026 and India's framework changed in 2020. Anyone manufacturing, importing or exporting should read the current text from the authority itself: CDSCO and the Ministry of AYUSH in India, the FDA's general wellness guidance in the United States, and the Medical Device Regulation in the EU. ## Common questions ### Does a Shirodhara machine need a licence to sell in India? Not as a medical device, provided its manufacturer states no medical purpose. CDSCO has published no classification for Panchakarma apparatus, and since April 2020 the Medical Device Rules apply by intended purpose rather than by list membership, so registration and licensing follow only once a medical purpose is stated. The oils are separate: a medicated taila is an Ayurvedic drug and its manufacture for sale needs a licence in Form 25-D from the State Licensing Authority, under Schedule T good manufacturing practice. ### What would turn one into a regulated medical device? The purpose its manufacturer states. Present a device as treating insomnia or hypertension and you have stated a medical purpose, which in the EU brings it inside the Medical Device Regulation and in the United States removes the FDA's general wellness forbearance. The same machine sold as wellness equipment sits outside both. ### Should I be suspicious of a vendor who advertises treatment of a condition? It is worth a second look, on two counts. They have taken on obligations their regulator will hold them to, and the published trials are few and small. One 2025 meta-analysis (PubMed 40104342) found a diastolic blood pressure effect its authors describe as of low clinical value, which is not efficacy for a named condition. If you resell such a product, repeating the claim in your own market makes it yours. --- Canonical version of this page: https://nighantu.ageayurveda.com/shirodhara/medical-device-status/ Published by Age Ayurveda in the Nighantu. Educational reference only, not medical advice.