On March 25, 2021, a notification was released specifying 19 more devices belonging to categories such as gloves, syringes, orthopedic products, x-ray machines, etc. that only local manufacturers could bid on.
On September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021.
In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.
With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.
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.
As of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt
On Saturday, the Indian Ministry of Finance released a Notification (No. 28/2021–Customs) exempting the following medical devices from customs duties effective immediately until July 31st. The Notification comes as the Indian government continues to take additional steps to battle the ongoing COVID-19 emergency.
India is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.
On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.