New Delhi, India To the relief of medical device manufacturers and importers, the Central Drug Standard Control Organization (CDSCO) has extended the deadline for submitting licence applications to June 30, 2022. The decision was made by the apex drug regulator because importers and manufacturers of CT Scan equipment, all implanted devices, MRI equipment, and other medical devices failed to obtain licences from the Central Licensing Authority or the State Licensing Authority within the time frame specified.
In order to ensure continued access to medical devices notified as drugs while the new regulatory order under the Medical Device Rules (MDR) 2017 is enforced, CDSCO has decided that an importer/manufacturer who is already importing /manufacturing medical devices including CT scan equipment, all implantable devices, MRI equipment, etc., and whose application has been submitted to the Central License Authority or State License Authority for grant of license would be deemed valid.
In addition, it also directed that 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 takes a decision on the said application.
The Central Government, after consultation with the Drugs Technical Advisory Board, had specified the following devices intended for use in human beings as drugs with effect from the 1st day of April 2020, namely
a.All implantable medical devices;
b.CT scan Equipment;
c.MRI Equipment;
d.Defibrillators;
e.Dialysis Machine;
f.PET Equipment;
g.X-Ray Machine;and
h.Bone marrow cell separator.
As per the new notification provisions of the Medical Device Rule (MDR), 2017, the importers and manufacturers are required to take an import or manufacturing licence from the Central Licensing Authority or a State Licensing Authority for the import or manufacture of the specified eight medicaldevices with effect from April.
However, in this regard, the stakeholders represented their concerns that due to the Covid-19 disruption, there is unpreparedness in complying with regulatory requirements within the prescribed timelines, which may lead to disruption of the supply chain and access to patients.
In light of the above forgoing, the CDSCO has issued a notice, stating,
“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 /manufacturingany 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 licence 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.”
Further, the notice stated that the applicant who 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.
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 the complete application.” The notice added.
“Furthermore, the importer/manufacturer of the above said medical devices has to obtain an import/manufacturing license for the above said devices by or before June 30th, 2022. The importer/manufacturer shall necessarily be required to print the import/manufacturing license numberon the label with effect from July 1st, 2022,” the notice read.
