Class A Non-Sterile Non-Measuring Device Exemption in India

1. Key takeaways

India grants an exemption for Class A devices that are non-sterile and non-measuring: Chapters IV (manufacture), V (import), VII (clinical investigation), VIII (investigational devices) and XI of the Medical Devices Rules, 2017 do not apply, and no manufacturing licence or import licence is required. But exemption does not mean freedom from obligations — the applicant must complete registration on the CDSCO medical device online portal, obtain the system-generated registration number, and comply with the Chapter VI labelling requirements and applicable standards. The exemption lowers the procedural burden dramatically for eligible products, yet it preserves the regulatory perimeter around them, and companies that read the exemption as deregulation expose themselves to avoidable enforcement risk. The correct reading is narrower and more useful: the exemption removes specific licensing steps for a tightly defined product population, and it does so on conditions that must be demonstrably true at registration and must remain true afterwards.

• Eligible Class A devices skip licensing chapters of MDR 2017 entirely.
• Online registration on the CDSCO portal is still mandatory.
• The registration number is system-generated; no certificate is issued.
• There is no fee for obtaining the registration number.
• Labelling obligations under Chapter VI and applicable standards remain.

2. Legal basis

The exemption was introduced by amendment and is confirmed operationally in the official CDSCO FAQ, which is the reference document practitioners rely on for its scope, its registration mechanics and its fee treatment. The table below consolidates the sources. Note that the FAQ entries and the amending notification work together: the notification creates the exemption in law, while the FAQ explains how it is administered in practice.

3. Expert insights

Insight one: all three conditions must hold simultaneously. To fall within the exemption, the product must satisfy, at the same time: first, classification as Class A; second, non-sterile supply, meaning the manufacturer does not intend the device to be supplied in a sterile state; and third, non-measuring, meaning it does not possess a regulated quantitative measuring function. If any one condition fails, the product returns to the regular MD-14/MD-15 route. Because the three tests draw on different kinds of evidence — the classification list, the manufacturer’s sterile-supply statement and the measuring-function assessment — eligibility must be documented on all three fronts rather than asserted on one.

Insight two: what is exempted is the licensing chapters, not the obligation chapters. Beyond the exempted chapters, the powers of inspection, sampling, confiscation and penalty under the subsequent chapters are fully retained. A drugs inspector can still act against non-conforming products under the Drugs and Cosmetics Act, and the sale of adulterated, spurious or misbranded products remains a criminal offence. The exemption changes the entry paperwork, not the enforcement exposure of the product in the market. Companies should therefore keep change control, complaint handling and labelling discipline at the same standard they would apply to a licensed device. In practice this also protects the exemption itself: a product whose label, claims or supply state drift after registration can quietly move outside the three conditions, and the drift is usually discovered only when an inspector or a competitor points at it.

Insight three: registration is self-declaration in character. Precisely because the process is fast, the two declarations made on signing — conformity and authenticity — carry more weight, not less. If a classification statement is later overturned, it cannot be excused as a clerical slip. The registration record becomes the manufacturer’s own written position on its product, and any discrepancy between that position and the product as actually marketed is a self-inflicted finding.

Insight four: product families commonly contain both eligible and ineligible versions. A dressing or kidney dish without graduations can be registered, while the graduated version intended for precise dosing may not qualify; a non-sterile dressing can be registered, while the same dressing in sterile form must be licensed. Each variant must be assessed separately, and family-level marketing descriptions that blur the boundary between variants create a documentation risk of their own.

4. Practical recommendations

• For every product proposed for the exemption route, GRZAN first prepares a three-condition determination sheet fixing the basis of the Class A classification, the sterile-supply statement and the reasoning on the measuring function, item by item.
• The labels, IFU and product photographs are attached and retained as the evidence file for the determination.
• Even where the portal does not require uploads, an internal dossier is built for every registered product: classification rationale, specifications, applicable standards and label artwork.
• That internal dossier is the only basis of defence if the registration is questioned later, so it is maintained with the same discipline as a licensed product’s technical file.
• Any borderline reading of the three conditions is treated as a practical estimate pending verification, not as a settled conclusion, until the determination sheet is complete.

5. Verification checklist

• □ The product is listed as Class A in the CDSCO classification list.
• □ The manufacturer does not supply the product sterile (supported by a written statement).
• □ The product has no quantitative measuring function (with documented reasoning).
• □ Registration on the medical device online portal is complete and the registration number obtained.
• □ The labelling complies with Chapter VI of MDR 2017.

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.