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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 Government
A 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 be
If 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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