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 28th, 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 1st, 2021.
For manufacturers and/or importers who have already applied for manufacturing/ import license for any of these devices before December 27th, 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 28th, 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 1st, 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 1st, 2021:
|1. X-Ray Machines|
2. CT Scan Equipment
3. MRI Equipment
4. PET Equipment
6. Dialysis Machines
7. Bone Marrow Cell Separators
8. All Implantable Medical Devices
Note: Ultrasound devices will then likely require Import Licenses beginning November 1st, 2021.
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 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement.