What is the CDSCO Import Licence Process?

CDSCO's import licence process is a multi-stage, document-intensive review conducted through the SUGAM portal. The form you file, the data you submit, and the entity that applies all depending on your device's risk class. Class C and Class D devices take 12 to 18 months to clear. Errors in documentation or incorrect classification extend that timeline and can result in application lapse.

What is the CDSCO import licence process?

The Central Drugs Standard Control Organisation (CDSCO) import licence process is the formal regulatory pathway by which a foreign medical device manufacturer and its Indian importer obtain legal authorisation to bring a medical device into India. The process is governed by the Medical Devices Rules, 2017 issued under the Drugs and Cosmetics Act, 1940. CDSCO headed by the Drugs Controller General of India (DCGI) administers the process centrally for Class C and Class D devices and through zonal offices for Class A and Class B devices.

The process begins on the SUGAM portal (cdscoonline.gov.in), with no paper-only alternative, the mandatory digital interface for all medical device registration and import licence applications in India. Both the foreign manufacturer and Indian importer must hold active SUGAM accounts.

The import licence process produces two distinct instruments depending on device class. For Class B devices, the output is a Form MD-14 import licence held by the Indian importer. For Class C and Class D devices, the output is a Form MD-15 registration held by the foreign manufacturer which the Indian importer then uses as the basis for importing under an associated licence. These are separate and mutually non-substitutable regulatory instruments.

The seven-step process

Step one is to determine the correct device class under MDR 2017's Third Schedule classification rules. For an uncertain classification, a written opinion from a qualified Indian regulatory consultant or a pre-submission inquiry to CDSCO be followed.

Step two is to establish SUGAM accounts. The foreign manufacturer, the Indian importer and the Authorised Indian Representative (for Class C and D) require separate SUGAM accounts using company registration documents, authorised signatory details and digital signature certification in the case of manufacturers. Account setup can take days to weeks.

Step three is to appoint an Authorised Indian Representative for Class C and D applications. The AIR must be a company or LLP registered in India and not an individual. AIR's details, including legal name, registered address, director information and written acceptance of regulatory responsibility are filed as part of the Form MD-15 application.

Step four is to compile the technical dossier. For Class B applications under Form MD-14, the dossier includes a certificate of free sale from the regulatory authority in the country of manufacture, technical documentation describing the device and its intended use, labelling, manufacturing site details and evidence of the quality management system. For Class C and D applications under Form MD-15, the dossier additionally includes full clinical evaluation data supporting safety and performance claims, a risk analysis conducted in accordance with recognised standards and any post-market surveillance data available.

Step five is to file the application through SUGAM and pay the applicable government fee. Once submitted, CDSCO assigns a docket number and the review begins. CDSCO issues a deficiency letter for an incomplete application. The applicant must cure deficiencies within the stipulated timeframe. Failure to do so causes the application to lapse, requiring re-filing and payment of fees again.

Step six is the review period. For Class A and B devices, review timelines are measured in months. For Class C and D devices, the standard review period runs 12 to 18 months. CDSCO may issue substantive queries during review asking for additional clinical data, clarification of intended use or supplementary manufacturing site information. Each query response must be filed through SUGAM within the stipulated response window.

Step seven is grant of the registration or licence. Upon approval, CDSCO issues the Form MD-14 or Form MD-15 instrument, accessible through SUGAM. The registration has a defined validity period and must be renewed before expiry. The renewal application should be initiated well in advance of the expiry date.

Implications for businesses

For foreign medical device manufacturers of Class C and D devices, the manufacturer is the applicant through Form MD-15 and bears responsibility for the technical accuracy and completeness of its own application. If CDSCO issues a query during review, the manufacturer must respond within the stipulated time or risk application lapse. The manufacturer cannot delegate this compliance to the Indian importer.

For Indian importers and distributors, the process means maintaining an active relationship with the foreign manufacturer throughout the registration period. An Indian importer whose foreign supplier fails to respond to CDSCO queries has no mechanism to compel a response.

Well-structured distribution agreements include obligations on the manufacturer to maintain CDSCO registration, respond to regulatory queries within defined timeframes and notify the Indian importer of any changes to the product or manufacturing site that trigger a variation application.

Legality and risks

The Drugs and Cosmetics Act, 1940 and MDR 2017 together make the import licence a legal prerequisite for any medical device entering India. Section 13 of the Act criminalises import in contravention of its provisions. Importing without a valid licence or before a licence has been granted, exposes the Indian importer and the foreign manufacturer's AIR to criminal liabilities with imprisonment up to three years, a fine or both.

An application lapse caused by failure to respond to a deficiency notice or query within the stipulated period requires the entire process to restart.

CDSCO's grant of a registration does not immunise a product from future regulatory action. Post-market surveillance can result in suspension or cancellation of a registration if adverse events emerge or if information submitted in the original application is found to have been inaccurate. The registration is a continuing obligation, not a one-time clearance.

Word of counsel

Importers should designate a specific individual with SUGAM access to monitor each application, set a calendar reminder to check the portal at least weekly and establish a clear internal escalation path so that a query notification triggers action within 24 hours. SUGAM portal should be monitored diligently to avoid application lapse during the review period.

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