Permission for Loan License to Manufacture Class C & D In- Vitro Diagnostics in India – MD-8 & MD-10


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    CliniExperts can assist in fulfilling all the requirements of CDSCO. The expert professionals at CliniExperts provide end-to-end support throughout the application process and submission of Form MD-8 for manufacturing the Class C and D IVDs. Completely updated with the latest guidelines by the CDSCO, CliniExperts helps obtain rapid approvals without any hindrances.

    Permission for Loan License to Manufacture Class C & D In- Vitro Diagnostics– Overview


    The regulatory body involved in overseeing the manufacturing of Class C and D IVD's is the Central Drugs Standard Control Organisation (CDSCO). A Loan manufacturing license in FORM MD-10 is needed by any manufacturer, as per provisions of the Medical Device Rules, 2017 for manufacturing the IVD's of Class C & Class D (Notified) in India.

    The application process takes about four to five months. A manufacturer must apply to the Central Licensing Authority through an identified online portal of the Central Government for a Loan license to manufacture for sale or distribution Class C & Class D IVD in Form MD-8 to obtain the license in FORM MD-10.

    What is MD-8 and MD-10

    Form Names

    MD-8

    FORM MD 8: is the application form required for grant of loan license to manufacture for sale or distribution of Class C or Class D medical device.

    MD-10

    FORM MD 10: is the Loan License certificate obtained to manufacture for sale or distribution of Class C or Class D Medical Device.

    Who Can Apply?


    A manufacturer can submit the application for permission to manufacture Class C and D IVD's through Form MD-8.


    How To Apply?

    A manufacturer can apply with following steps:
    Step 1: Online registration of the applicant at the SUGAM Registration portal.
    Step 2: Drafting the online application in prescribed proforma
    Step 3: Uploading the documents as per the checklist of Form MD-8
    Step 4: Paying the requisite Government Fee
    Step 5: Submission of application on Online medical device portal

    Fee Involved

    The Government charges certain fees for a Loan license to manufacture Class C or Class D medical devices. The fees involved for Class C or Class D for one site of manufacturing medical devices is INR 50000 , whereas each distinct Medical Device costs INR 1000 .

    Validity

    A license issued in Form MD-10 has life-long validity. They are valid forever subject to the timely payment within five years of the issue date or could get suspended/ cancelled upon failure in payment by the Central Licensing Authority.

    Important Documents

    The necessary documents for the application are Device Master File Device Master File Site Master File

    Timeline to get Form MD-10 from Central Drugs Standard Control Organisation

    The timeline to obtain Loan License for Manufacture Class C and D IVD's is 4-5 months.

    Essential Tips

    The essential things to keep in mind during this license application preparation and submission process:

    The applicant’s manufacturing site should comply with the requirements of the Quality Management System as specified under the Fifth Schedule.


    The Device Master files and site master files must be prepared per the format for Medical Device Rules, 2017.

    Manufacturers might face delay in receiving license or other problems during the application filing process if-

    The technical documents of the products are not in line with the MDR 2017.


    The principal manufacturer does not have a license as per the MDR 2017.

    Expert Advise

    The professionals at CliniExperts advise their clients that while submitting the application, the quality control data must be generated on the basis of a valid Test License.

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    Frequently Asked Questions

    When is inspection expected by the CDSCO for the manufacturing site of Class C& D IVD?

    The expected period for the inspection by the CDSCO for the manufacturing site of Class C & D IVDs is within sixty days from the application submission date.

    In case of a loan license facility, will there be a re-inspection if the loan facility is a licensed manufacturing facility?

    In case of a loan license facility, will there be a re-inspection if the loan facility is a licensed manufacturing facility?

    How many members of the Audit team are prescribed in MDR 2017?

    As per the MDR 2017, for the Audit, a team comprises two Medical Device Officers, including any officer senior to the Medical Device Officer with or without an expert or a Notified Body.

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