EMERGO SUMMARY OF KEY POINTS:

• Notified medical devices require Import Licenses in order to be sold in India.
• All IVD products both notified and non-notified must also have Import Licenses for legal sales in India.
• Obtaining an Import License is the last step in the Indian CDSCO’s registration process for devices and IVDs.

India’s medical device registration system is still transitioning to a more formalized and predictable framework, which has raised questions from foreign manufacturers about what regulators do and do not currently require for market authorization in the country. In many cases, one requirement foreign firms can be sure of is the need to obtain an import license in order to properly register their products in India.

For medical devices and IVDs that require registration with the Indian Central Drugs Standard Control Organization (CDSCO), applying for and obtaining an Import License are the last steps in the approval process. But first, foreign manufacturers must determine whether their products require CDSCO registration at all.

Notified or not?

Under the existing Indian medical device and IVD approval system, only some types of devices require CDSCO registration—including Import Licensing—in order to be legally sold. The CDSCO maintains a list of “notified” device types that require registration; notified devices include cardiac stents, catheters, condoms, drug eluting stents and heart valves.

Thus, foreign manufacturers must first determine whether their devices are notified and require CDSCO registration in order to see whether they’ll have to obtain Import Licenses.

What about a non-notified medical device or IVD?

The CDSCO’s list of notified devices does not cover all types of medical devices or IVDs. In the case of non-notified medical devices, these products do not require registration, and their manufacturers do not need to obtain Import Licenses before commercialization in India.

However, the CDSCO does require Import Licenses for all IVD products, even non-notified IVDs.

Obtaining an Import License

Once all other steps of CDSCO registration, described in Emergo’s India regulatory process chart, have been completed, firms then apply for Import Licenses at the same time as they identify their chosen distributors for the Indian market.

Once a registrant has obtained an Import License, known as Form 10, commercialization may begin; your Import License is valid for the same amount of time as your device registration.

For more information on Indian medical device registration, watch our video overview.