Certain Medical Devices in India will be Considered as Drugs as of 30 June 2022

By Fajar Dumadi | November 23, 2021

On February 8, 2019, the Ministry of Health & Family Welfare, Government of India, has notified that the following devices were regulated as drugs; effective from April 1, 2021:

• All implantable medical devices
• CT scan equipment
• MRI equipment
• Defibrillators
• PET equipment
• Dialysis machine
• X-Ray machine
• Bone marrow cell separator

However, due to there being a lot of procedural work to implement such a policy, the stakeholders requested an extension. Therefore, through its notification (1) in April 18, 2021, the Ministry of Health has extended the timeline to implement the policy for another 3 to 6 months.

On November 3, 2021, COVID-19 has further disrupted the implementation of the policy. Therefore, in order to ensure smooth transition, continuity of supply chain, and access to the patients, the Ministry of Health has decided that (2):

• Import/manufacturing licenses for such devices must be obtained by or before June 30, 2022. The importer/manufacturer will be required to print the import/manufacturing license number on the label, effective from July 1, 2022.
• For the existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, the said application is deemed to be valid. The importer/manufacturer can continue to import/manufacture the said device(s) up to June 30, 2022, or till the time the Central License Authority or State License Authority (as the case may be) takes a decision on the said application, whichever is earlier.
• The applicants whose application was submitted by or before April 18, 2021 and considered as incomplete, is required to ensure submission of all the necessary documents to the concerned Authority by March 31, 2022.