Import Licenses Now Required for Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers

With the release of File No.:29/Misc./03/2020-DC (297), on December 28^th, 2020, the Central Drugs Standard Control Organization (CDSCO) now requires Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers obtain Import Licenses prior to marketing. There are now 28 Notified product categories that require Import Licenses while all others can register voluntarily until October 1^st, 2021.

Grace Period

For manufacturers and/or importers who have already applied for manufacturing/ import license for any of these devices before December 27^th, 2019 (Release of Notification for Extension of the Implementation- S.O. 4671(E)), applications shall be considered valid by the CDSCO. They can continue to import up to 6 months from issue of this order (i.e., up to June 28^th, 2021) or until approval is granted for the submitted application, whichever is earlier.

Local manufacturers and importers who have not yet applied for a manufacturing/ import license cannot release or import devices as of January 1^st, 2021.

More Devices Expected to Become Notified in April

Given that the release of this order is on schedule, it is expected that the CDSCO will continue implementing additional Notified devices in April as planned.

It is recommended that manufacturers of the below product categories submit applications for Import Licenses immediately to ensure market access is not interrupted. The following items have a deadline of April 1^st, 2021:

Note: Ultrasound devices will then likely require Import Licenses beginning November 1^st, 2021.

Transition Summary

Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices”. The registration process will generate a file number the same day and must be included on the label prior to marketing.

After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1^st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1^st, 2023) to meet the same requirement.