CDSCO reminds medical device firms to pay retention fee to continue holding licenses & certificates

The Central Drugs Standard Control Organisation (CDSCO) has requested
all stakeholders in the medical devices sector to deposit the requisite
fee for retention of license or registration certificate under the
Medical Devices Rules (MDR), 2017, well before the stipulated timeline
in order to avoid cancellation of the approvals.The drug
regulator, in a circular recently, reminded that while the license for
manufacturing or import of medical devices and registration certificate
for Quality Management System (QMS) audit by notified body, as well as
for Medical Devices Testing Laboratory is issued in perpetuity, it is
subject to the condition that a payment of requisite fee may be
deposited in stipulated timeline under the MDR, 2017. If the fee is not
paid on time, the license or certificates will be suspended or cancelled
by the licensing authority.Further, the endorsement to the
licenses/certificates issued will also be valid till the validity of its
base license/certificate. If the requisite fee is not deposited by the
applicant as per stipulated timeline, the license/certificate shall be
deemed to have been cancelled.“In view of the above, all the
stakeholders are requested to ensure that the requisite fee may be
deposited in appropriate account of the Government, well before the
stipulated timeline under MDR, 2017 and also submit the application to
the Licensing Authority in order to maintain continuity of the product
in the market,” said the drug regulator in an intimation to the
stakeholders including industry associations and all the notified
bodies, among others.According to the MDR, 2017, the
Registration Certificate shall remain valid in perpetuity, unless, it is
suspended or cancelled, provided the registration certificate holder
deposits a registration retention fee as specified in the Second
Schedule every five years from the date of its issue.If the
registration certificate holder fails to pay the required registration
certificate retention fee on or before due date, the registration
certificate holder shall, in addition to the retention fee, be liable to
pay a late fee calculated at the rate of two per cent of the
registration certificate retention fee for every month or part thereof
within ninety days, and in the event of non-payment of such fee during
that period, the registration certificate shall be deemed to have been
cancelled.The Rule says that aA registered Notified Body may
charge fee from the applicant for the services rendered by it as may be
determined by the Central GovernmentA licence or loan licence
issued in Form MD-5, Form MD-6, Form MD-9 or Form MD-10 shall remain
valid in perpetuity, subject to payment of licence retention fee as
specified in the MDR, 2017 before completion of the period of five years
from the date of its issue, unless, it is suspended or cancelled by
State Licensing Authority or the Central Licensing Authority, as the
case may beIf the licence holder fails to pay the required
licence retention fee on or before due date, the licence holder shall,
in addition to the licence retention fee, be liable to pay a late fee
calculated at the rate of two per cent. of the licence retention fee for
every month or part thereof within one hundred and eighty days and in
the event of non-payment of such fee during that period, the licence
shall be deemed to have been cancelled, says the Rules.According
to the MDR, 2017, the fee for registration of notified body, and
retention of registration is Rs 25,000, while for manufacturing or loan
license to manufacture Class A and Class B medical devices is fixed at
Rs 5,000 for one site and Rs 500 for each distinct medical device.Fee
for manufacturing licence or loan license to manufacture class C and
Class D medical devices, for one site, is Rs 50,000 and Rs 1,000 for
each distinct medical device. The retention fee for manufacturing and
loan license is Rs 5,000 per site manufacturing Class A or Class B
medical devices, Rs 50,000 per site of manufacturing Class C and Class D
medical devices and Rs 500 and Rs 1,000 for each distinct medical
devices of Class A or Class B and Class C or Class D medical devices,
respectively.Import licence for Class A medical devices other
than in vitro diagnostics medical devices is fixed at $1000 for one
site, and $50 for each distinct medical device. Import license for Class
B devices other than in vitro diagnostic devices is $2,000 for one site
and $1000 for each distinct medical device. Import License for Class A
or Class B in vitro diagnostic medical devices is fixed at $1000 for one
site and $10 for each distinct in vitro diagnostic medical device.Import
license for Class C or D medical devices other than in vitro diagnostic
medical devices is $3,000 for one site and $1,500 for each distinct
medical device. Import License for Class C or D in vitro diagnostic
medical devices for one site is fixed at $3000, while fee for each
distinct in vitro diagnostic medical device is $500. Import license
retention fee for the medical devices ranges from $1000 to $3,000
depending upon the class of devices.

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