India forks manufacturing licensing by class, not import

A market-access tracker built for India usually encodes one fact about a device: its risk class, A through D under the Medical Device Rules, 2017. That fact routes a domestic manufacturing licence correctly on its own — Class A and B applications go to a State Licensing Authority, Class C and D go straight to the Central Licensing Authority in New Delhi. It does not route an import licence, because import doesn't fork by class at all. Every imported device, whatever its class, clears the same central desk. A tracker built on the assumption that India's two licensing tracks mirror each other has miscoded whichever one it copied from.

Two forms decide where a domestic licence lands

India's four-class scheme — A, B, C, D, running low risk to high — follows the same GHTF-style logic several other jurisdictions use, but the Medical Device Rules, 2017 don't route every class through the same office once a manufacturer applies to build one. A Class A or B application goes in on Form MD-3 and is granted, by the State Licensing Authority of the state where the manufacturing site sits, as Form MD-5. A Class C or D application goes in on Form MD-7 and is granted, by the Central Licensing Authority in New Delhi, as Form MD-9. The State Licensing Authority is expected to clear a Class A or B application within 45 days of a satisfactory site inspection; the Central Licensing Authority runs the same kind of evaluation for Class C and D on its own timeline. Two devices sitting one class apart on the same risk ladder can end up answering to two different regulators, in two different cities, for the same manufacturing activity.

Import ignores the fork manufacturing uses

An importer bringing a finished device into India doesn't get to use either state track, regardless of class. Import runs on its own pair of forms — an application on Form MD-14, a licence granted as Form MD-15 — filed through CDSCO's SUGAM portal and issued exclusively by the Central Licensing Authority, for a Class A device exactly as much as for a Class D one. The class-based fork that decides which office licenses a factory has no equivalent on the import side; there is one desk, and every class uses it. The two licences don't even run on the same clock: a manufacturing licence renews on a fixed cycle, while an import licence granted as Form MD-15 stays valid indefinitely against a retention fee due every five years, rather than a document a state authority reissues on its own schedule.

The same portfolio can carry licences from three different authorities

A company that manufactures a Class B device domestically in one state, sources a Class A accessory from a contract manufacturer in another, and imports a Class D device from an overseas plant is holding manufacturing licences from two separate State Licensing Authorities and an import licence from the Central Licensing Authority — three authorities, none of them redundant, none of them substitutable for another. The pattern echoes Health Canada's split between a company-level establishment licence and a device-level authorization, except India's fork runs by class on one axis and by activity — manufacture versus import — on the other, and only one of those two axes applies to each licence.

A renewal calendar has to track the fork, not just the class

Licences granted as Form MD-5, MD-6, MD-9, or MD-10 run for five years before a state or central authority has to act on renewal again, and a portfolio spanning multiple states multiplies that calendar by however many State Licensing Authorities are actually involved, each running its own timeline independent of the others. A program that reads India as a single country-level line, the way a reviewer track sorted by class in Korea might get read as one decision, has usually collapsed a structure that actually forks twice over: once by class for manufacturing, and not at all for import.

Where this meets the file

A CDSCO tracking record needs separate fields for a device's manufacturing licence — authority, form number, and state, where a state authority is involved — and its import licence, which is always Form MD-14/MD-15 through the Central Licensing Authority regardless of class, rather than one combined “India: licensed” status line. A licensing worksheet built around that split is previewed in the launch catalog. If your program has tracked India's licences differently, the shelf takes that correction directly.