This order pertains to the regulation of CT scan equipment, all implantable devices, MRI equipment, etc., as drugs.
It provides an extension to the timeline for manufacturers/importers to comply with regulatory requirements under the Medical Devices Rules (MDR), 2017.
The extension is granted due to disruptions caused by the Covid-19 pandemic.
Key Changes
Existing manufacturers/importers who submitted applications for import/manufacturing licenses by April 18, 2021, can continue to import/manufacture these devices until June 30, 2022, or until the Central License Authority or State License Authority makes a decision on their application, whichever is earlier.
Applicants with incomplete applications submitted by April 18, 2021, must submit all necessary documents by March 31, 2022.
Central Licensing Authority or State Licensing Authority must dispose of complete applications within three months from the date of receipt.
Manufacturers/importers must obtain the necessary import/manufacturing licenses by June 30, 2022.
The import/manufacturing license number must be printed on the label of the devices starting July 1, 2022.
Impact Analysis
Manufacturers/Importers
Action Item: Prepare to print the import/manufacturing license number on the label of the devices starting July 1, 2022.
Patients
No specific action required.
Central/State Licensing Authorities
No specific action required.
Supply Chain
No specific action required.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
MoHFW: Ministry of Health and Family Welfare.
MDR, 2017: Medical Devices Rules, 2017.
Central License Authority: The authority responsible for granting import/manufacturing licenses at the central level.
State License Authority: The authority responsible for granting import/manufacturing licenses at the state level.
F. No. 29/Misc/03/2021-DC (28)
Central Drugs Standard Control Organisation,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
Government of India
*******
FDA Bhawan, New Delhi
Dated 03.11. 2021
ORDER
Subject: Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as
Drugs with effect from April 1st, 2021- Regarding.
1. Whereas order of even number dated 18.04.2021 on the subject cited matter was issued by
CDSCO (copy enclosed).
2. Whereas the stakeholders have now represented their concerns that due to Covid-19
disruption there is unpreparedness in complying with regulatory requirements within the
prescribed timelines, which may lead to disruption of supply chain & access to patients.
3. Now, therefore, in order to ensure smooth transition of manufacturers/importers, continuity
of supply chain and access to the patients, with the approval of MoHFW, it has been decided
that in case an 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, as the case may be, for grant of import/manufacturing license in
respect of the said device(s) under provisions of MDR, 2017 by 18.04.2021, the said
application shall be deemed to be valid and the importer/manufacturer, can continue to
import/manufacture the said device(s) up to 30.06.2022 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.
4. Further, the applicant, in case has submitted an incomplete application (submitted by or
before 18.04.2021), is required to ensure submission of all the necessary documents to the
concerned Authority, by 31.03.2022.
5. Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose
of these applications within three months from the date of receipt of complete application.
Page 1 of 26. Further, the importer/manufacturer of above said medical devices has to obtain
import/manufacturing license for the above said devices by or before 30th June, 2022. The
importer/Manufacturer shall necessarily be required to print the import/manufacturing
license number on the label with effect from 1st of July 2022.
(Dr V. G. Somani)
Drugs Controller General (India)
To
All States/UTs Drugs Controllers.
Copy to:
1. All Zonal/Sub-Zonal /Port offices of CDSCO
2. All Stakeholders/Associations through CDSCO website
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