Registered Entity Roles in India: Manufacturer, Agent and Importer

1. Key takeaways

Four distinguishable identities exist in the Indian device supply chain: the foreign manufacturer (which cannot apply on its own and must issue a power of attorney), the Authorised Indian Agent (AIA) (which holds the power of attorney and applies to the CLA for the import licence, and is the legally responsible person in India), the importer (the entity that imports under licence, usually the same entity as the AIA), and the wholesaler (which must separately hold an MD-42 or a wholesale licence under the drugs rules). The credentials of the four identities do not substitute for one another. Mapping these roles correctly, and documenting them in agreements, is a precondition for every import project, because the licence that authorises the product and the registrations that authorise the entities are separate instruments issued to different holders. Confusing the two layers — assuming that a product licence confers entity credentials, or the reverse — is one of the simplest and most frequent planning errors in Indian market entry.

• The foreign manufacturer cannot file in India; it must appoint an agent.
• The AIA files the import application and is the responsible person in India.
• The importing entity usually combines the AIA and importer roles.
• Wholesale distribution requires its own registration or licence.
• None of the four credentials substitutes for another.

2. Legal basis

The eligibility rules for import, the definition of the authorised agent and the wholesale registration regime come from different layers — the official CDSCO position, the Rules themselves and the CDSCO FAQ. The table below consolidates them. Read together, they explain why agent selection is a compliance decision rather than a commercial one: the agent must already hold a qualifying credential before the import application can even be filed.

3. Expert insights

Insight one: the foreign manufacturer has no standing to apply in India. This is a feature India shares with many markets, but the distinctive Indian element is the hard requirement on the AIA’s own licensed status — the AIA must already hold one of the three qualifying credentials, a manufacturing licence, a wholesale licence or the MD-42, before it can file the MD-14. This converts appointing an agent from a commercial choice into a compliance precondition. Projects that select an agent on price alone, then discover the agent lacks the qualifying credential, lose the time they thought they were saving.

Insight two: a drugs wholesale licence can be reused. If the candidate agent is already a pharmaceutical wholesaler holding Form 20B, 21B or 21C, it qualifies as it stands and need not obtain the MD-42 separately. This is a significant convenience for companies already doing pharmaceutical business in India, and it means choosing an agent with a pharmaceutical background saves one licence. The converse is also worth noting: a pure device trader starts from zero and must budget for the MD-42 and the SLA inspection of its premises before it can file anything.

Insight three: the AIA is the legally responsible person, not merely a contact point. It files the documents, answers queries, and remains responsible for post-market compliance — vigilance, recalls and change notifications. Changing the AIA requires a fresh import application, which makes the choice a structural lock-in. The practical implication is that agent selection should be made with exit scenarios in mind from day one, because the cost of leaving a badly chosen agent is a full re-filing rather than a paperwork transfer. It also means continuity of the AIA relationship has direct commercial value: every year the relationship survives unchanged is a year in which the licence chain does not have to be rebuilt.

4. Practical recommendations

• GRZAN screens Indian agents with a fixed enquiry list, applied identically to every candidate so that the answers are comparable.
• First, the type and number of credentials currently held (manufacturing licence, wholesale licence or MD-42).
• Second, whether the warehouse address and area meet the SLA inspection requirements; third, whether the candidate has registration experience with devices, not only with drugs.
• Fourth, whether it accepts the client being listed as an informed party in the jointly held documents; fifth, how the handover of documents on a change of agent is contractually arranged.
• The fifth item is the most commonly overlooked, yet it is the only safeguard for a safe exit from the project — and its absence is felt precisely when the relationship has already turned sour.

5. Verification checklist

• □ The candidate agent already holds one of: a manufacturing licence, a wholesale licence or the MD-42.
• □ The Power of Attorney has been signed by the overseas manufacturer and legalised.
• □ The agent’s warehouse and personnel conditions meet the SLA inspection requirements.
• □ The agent has device (not merely pharmaceutical) registration experience.
• □ The agent agreement stipulates the document handover obligations on a change of agent.

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.