What is the Role of the Authorised Indian Representative Under CDSCO?
The Authorised Indian Representative (AIR) is a legally recognised entity appointed by a foreign medical device manufacturer to represent it before the Central Drugs Standard Control Organisation (CDSCO) in India.…
For Class C and Class D medical devices, every foreign manufacturer must appoint an Authorised Indian Representative before filing for CDSCO registration. The AIR must be a legally registered Indian company or LLP, not an individual. The AIR accepts legal responsibility for the manufacturer's regulatory obligations in India. Appointing the wrong entity creates regulatory exposure for both the manufacturer and the AIR.
What is the authorised Indian representative under CDSCO?
The Authorised Indian Representative (AIR) is a legally recognised entity appointed by a foreign medical device manufacturer to represent it before the Central Drugs Standard Control Organisation (CDSCO) in India. The AIR requirement is established under the Medical Devices Rules, 2017, operative from 1st January 2018 and issued under the Drugs and Cosmetics Act, 1940. The AIR framework is specific to Class C and Class D medical devices where the foreign manufacturer itself is required to register under Form MD-15.
The AIR is a regulatory actor that ensures a foreign manufacturer with no physical presence in India has a legally accountable entity within Indian jurisdiction. CDSCO uses the AIR as the point of regulatory contact for queries, inspections, adverse event notifications, product recalls, and enforcement actions arising from the manufacturer's registered devices.
The Drugs Controller General of India (DCGI) requires that the AIR's details, including legal name, registered address, director information and a signed declaration of acceptance of responsibility be filed as part of every Form MD-15 application. A change of AIR after registration requires a variation application filed through the SUGAM portal (cdscoonline.gov.in). CDSCO must approve the change before the new AIR is formally recognised.
AIR in different regulatory frameworks
Under the Bureau of Indian Standards (BIS), the Authorised Indian Representative can only be an individual and whereas under CDSCO, the AIR must be a legal entity, specifically a company incorporated under the Companies Act, 2013 (as amended to-date) or a Limited Liability Partnership registered under the Limited Liability Partnership Act, 2008. An individual cannot serve as the CDSCO AIR for a Class C or D device even if they are technically qualified or commercially experienced.
How the AIR requirement works
The AIR appointment process begins before the Form MD-15 application is filed. The foreign manufacturer selects an Indian legal entity to serve as its AIR. The parties negotiate and execute an AIR appointment agreement that defines the scope of the AIR's authority, the regulatory responsibilities it accepts and the obligations of the manufacturer to cooperate with the AIR's compliance functions. The agreement is not filed with CDSCO but its terms govern the practical operation of the AIR relationship.
The AIR's legal name, registered address and a signed declaration of acceptance of regulatory responsibility are included in the Form MD-15 application filed through SUGAM portal. The declaration must be executed by an authorised signatory of the AIR entity. A Deficiency Notice is issued by CDSCO where AIR details are incomplete or the entity cited does not appear to be a legally registered Indian company or LLP.
Once the Form MD-15 registration is granted, the AIR becomes the CDSCO-recognised regulatory contact for that manufacturer's registered devices. CDSCO directs query letters, inspection notices and adverse event follow-up communications to the AIR and failure to respond creates regulatory risk leading to suspension or cancellation of a registration.
The AIR is also responsible for coordinating post-market surveillance obligations. MDR 2017 requires manufacturers to report serious adverse events involving their devices where the AIR files reports with CDSCO through SUGAM portal within the prescribed timelines.
Changing the AIR requires filing a variation application through SUGAM providing details of the new AIR entity, its signed declaration of acceptance and evidence of the termination of the prior AIR appointment which is reviewed by the CDSCO before approval.
Implications for businesses
For foreign medical device manufacturers, AIR is the most consequential third-party relationship in their India regulatory structure that formally accepts legal responsibility for the manufacturer's compliance with MDR 2017 in India.
For Indian companies considering the AIR role, the legal risk comes from direct engagement in the CDSCO regulatory framework. An Indian company that serves as AIR for multiple foreign manufacturers accepts regulatory liability for each of those manufacturers' products in India.
For Indian importers and distributors, the AIR's existence and validity directly affects the importer's ability to clear goods. The import licence for a Class C or D product is linked to the foreign manufacturer's Form MD-15 registration, which is in turn linked to a specific AIR. A distributor who is not the AIR must monitor the AIR status of their supplier's registration with the same diligence they apply to their own import licence renewal.
Legality and risks
The Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 establish the AIR requirement as a legal condition of Class C and D device registration. Importing a Class C or D device without a valid Form MD-15 registration, which cannot exist without a properly appointed AIR violating Section 13 of the Act and imprisonment imposed up to three years, a fine or both applicable to the Indian importer and to the AIR.
An AIR that accepts the appointment but fails to discharge its regulatory responsibilities, for example, by failing to file adverse event reports or to respond to CDSCO queries exposes itself to direct regulatory action. CDSCO can take enforcement action against the AIR in India independently of any action against the foreign manufacturer abroad.
Word of counsel
Importers should appoint a dedicated regulatory compliance entity as AIR rather than their Indian distributor with a primary motivation is regulatory compliance, not commercial throughput.
In case of an adverse event or CDSCO issues a technical query, a distributor-AIR is often poorly equipped to respond with the technical rigour CDSCO expects. Manufacturers should plan AIR transitions carefully and initiate variation applications well before any anticipated change.
A foreign manufacturer should ensure that the AIR appointed understands and is resourced to discharge this responsibility has created a structural weakness in its India regulatory framework. The AIR should maintain its own internal systems for monitoring the compliance status of each manufacturer it represents.
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