Measuring Function Definition for Class A Devices in India

1. Key takeaways

India applies a dual test of intended use plus unit display to determine whether a medical device is a device with a measuring function. A device is considered to have a measuring function where the manufacturer intends it to be used for quantitative measurement of a physiological or anatomical parameter, or of a quantifiable characteristic of energy or substances delivered into or removed from the body, and the measurement result is displayed in legal units or other accepted units. The presence of graduations alone does not make a device a measuring device; the decisive question is the intended use. This distinction decides which filing route is open, and it is one of the most frequent points of misjudgement in Class A exemption planning.

• The test combines intended use, the quantity measured and the unit display.
• Graduations on a product are not, by themselves, a measuring function.
• The official definition is given in CDSCO FAQ question 72.
• Measuring function is one of the three disqualifiers for the Class A exemption.
• The assessment is made on the English-language materials actually marketed.

2. Legal basis

The operative definition is administrative rather than statutory, given in the CDSCO FAQ, and it interacts with the classification provisions of the Rules and with the Class A exemption. The three sources below should always be read together, because the same product may sit under all three at once: it must be classified, its measuring status must be judged, and the exemption depends on the outcome of both.

CDSCO Frequently Asked Questions on the Medical Devices Rules, 2017, question 72:

“Any medical device intended by the manufacturer for the quantitative measurement of a physiological or anatomical parameter, or of the quantity or a quantifiable characteristic of energy or substances (including drugs) delivered into or removed from the human body, and where the result of the measurement is displayed by the device in legal units or other acceptable metrological units, is deemed to be a medical device with a measuring function.”

3. Expert insights

Insight one: the sequence of the assessment is use, then quantity, then units. Step one asks whether the intended use declared in the IFU and on the labels includes quantitative measurement. Step two asks whether what is measured is a physiological or anatomical parameter, or a quantity of energy or substances delivered into or removed from the body. Step three asks whether the result is displayed in units. Only when all three steps are satisfied is the device a measuring device. Working the steps in order matters, because a device can display numbers for convenience without its intended use being measurement, and treating every displayed number as a measuring function would sweep in ordinary products that the definition was never meant to capture.

Insight two: a scale is not a measurement. An ordinary container is not a measuring device; the same container, if graduated and intended for precise dosing, may be found to be one. The dividing line is whether the manufacturer holds out quantity as a function of the device in its claims. This is a documentation question before it is an engineering question: the answer lives in the words the company chooses for its labelling and instructions, not in the moulded lines on the product.

Insight three: the eligibility risk of the exemption route sits exactly here. Measuring function is one of the three disqualifying conditions of the Class A exemption. Registering a Class A product that does have a measuring function through the exemption route has a severe consequence: the registration does not confer manufacturing or import authorisation — the product is in substance unlicensed, falling directly under s.27(b) of the Drugs and Cosmetics Act. The saving in fees and time achieved by the wrong route is trivial against the exposure it creates.

Insight four: the judgement is made on the English text of the product labelling and IFU. CDSCO looks at the materials actually placed in the Indian market. If the Chinese instructions say the product is for holding only, but the English IFU says it is graduated for accurate dosing, the English governs. Companies marketing in multiple languages must therefore keep their claims consistent across languages, because the strictest reading of any market-facing text will be the one applied.

4. Practical recommendations

• GRZAN does not judge the measuring function from the product name; it prepares a three-column comparison: the claim in the home-market materials, the English IFU text and the label artwork.
• Whenever the English materials contain wording conveying quantitative readings together with units, the product is treated strictly as having a measuring function and routed through the regular MD-14/MD-15 channel.
• Claims are aligned across all language versions of the IFU and labelling before filing, so that the Indian-market English text cannot contradict the source materials.
• The determination is recorded in the classification rationale file together with its reasoning, so that the same conclusion can be defended consistently if queried.
• The trade-off is stated openly to the client: the cost of being strict is fees and time; the cost of being lenient is criminal risk — and that calculation is not left to chance.

5. Verification checklist

• □ The English IFU has been checked for quantitative measurement wording.
• □ The label artwork has been checked for graduations and units.
• □ The object of measurement falls within physiological or anatomical parameters, or quantities delivered into or removed from the body.
• □ The home-language claims and the English materials are consistent.
• □ The determination has been written into the classification rationale file.

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.