Class A Online Registration in India: Mandatory, Fee-Free, and Without a Certificate

1. Key takeaways

Class A (non-sterile and non-measuring) medical devices in India are not required to obtain a manufacturing or import licence, but they must complete a registration on the CDSCO medical device online portal, and they receive a registration number generated automatically by the system in return. The registration carries no fee, and no registration certificate is issued for it. This combination — an obligation that is mandatory yet certificate-less and cost-free — is unusual among regulatory regimes, and it produces a distinctive practical problem: companies hold proof of nothing they can physically present downstream. Distributors, customs brokers and e-commerce platforms all expect a document, and the portal record must substitute for one. The exemption also has limits that are easy to overlook: it removes the licensing chapters from the framework for this subset of devices, but it does not remove the labelling obligations or applicable standards, and it certainly does not remove liability under the parent drugs law for products that turn out to be substandard or misbranded. Getting the classification boundary right at the start is therefore the whole game, because everything downstream — the registration, the labelling review, the distributor arrangements — follows from whether the device is genuinely non-sterile and non-measuring. Companies should also understand that the exemption is anchored in a specific amendment, not in informal administrative practice, which means the scope of what is exempt is fixed by published text and can be traced, checked and cited whenever a distributor or platform challenges the arrangement.

2. Legal basis

The table below collects the official FAQ answers that define the exemption, the mandatory registration, the absence of fees, and the obligations that survive the exemption, together with the amendment that introduced it.

3. Expert insights

Insight one: the very absence of a certificate is itself a risk point. What the company receives is a system-generated registration number, not a certificate that can be shown to distributors, customs or e-commerce platforms. In practice, the missing document form repeatedly drives downstream counterparties to demand proof. GRZAN’s approach is to retain the portal-generated registration record as a full-page capture and to attach a cover letter explaining the registration number, so that downstream verification has something concrete to work with instead of an argument.

Insight two: registration is a self-declaration, and signature means responsibility. The portal requires declarations on classification, statements of conformity and commitments to truthfulness. These are representations made to the regulator. If they are later found not to hold, the company cannot escape on the basis that the form was filled in wrongly; the declaration binds the declarant, which makes the underlying classification analysis a legal document rather than an internal memo.

Insight three: registration happens on a portal, not through a submission. Because there is no approval workflow, there is no deficiency notice. An error will not be returned for correction; it will surface later, during an inspection or a complaint. This is a channel with no feedback, and the practical effect is that any defect in the registration remains hidden until the worst possible moment, which is exactly when a regulator or a competitor is looking. The only protection is the quality of the work done before submission: a carefully reasoned classification and a complete, accurate portal entry are what stand between the company and a delayed, expensive discovery.

Insight four: the exemption does not touch quality offences. Registering a device does not exempt it from the adulteration, spurious and misbranded provisions of the Drugs and Cosmetics Act. Anyone selling a substandard product remains fully exposed to the penalties, and the portal registration offers no shelter from that exposure whatsoever. Sales, regulatory and quality teams should therefore share the same understanding: the exemption simplifies market entry paperwork, but it changes nothing about the responsibility attaching to what is actually sold.

4. Practical recommendations

• Build a registration dossier package for every product taking the exemption route: the portal registration record, a draft English label, the IFU, the non-sterile statement, the written reasoning for the non-measuring determination, and the list of applicable standards.
• Treat this package as internal-only documentation: the portal does not ask for it, but it is the only defence material available at an inspection, and it is the working basis for a fast update if CDSCO later issues a labelling prefix rule for registration numbers (the G.S.R. 883(E) draft).
• Capture and archive the portal registration record in full, and prepare the explanatory cover letter at the same time, so downstream partners receive a single coherent package.
• Put the classification reasoning in writing and have it reviewed before the declarations are signed, because signature converts the classification from an opinion into a responsibility.

5. Verification checklist

• □ Registration has been completed on the medical device online portal and the registration number obtained
• □ The registration record has been retained as a full page and can be produced at any time
• □ The non-sterile statement and the non-measuring determination reasoning have been documented in writing
• □ Labels comply with the Chapter VI requirements
• □ An internal registration dossier package has been established (not required by the portal, but indispensable)

Regulatory information verified as of October 27, 2026.

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