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Endorsement of Predicate In Vitro Diagnostics in Loan License in India - MD 8 & MD 10


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    CliniExpert-usp test license

    Unlock manufacturing excellence with CliniExperts! Secure your MD-10 Loan License for Class C/D Medical Devices effortlessly. With 10+ years of regulatory compliance experience, our expert team ensures swift approvals. Trust our industry network for efficient solutions. Elevate your business today! Contact us for streamlined regulatory success.

    Endorsement of Predicate In Vitro Diagnostics in Loan License – Overview

    According to the 2017 Medical Device Rules, manufacturers need a loan manufacturing license from the CDSCO. The (FORM MD-10) is used to produce additional products under an existing approved license. This applies specifically to manufacturing medical devices of Classes C and D in India. Manufacturers need to apply to the Central Licensing Authority (CLA). It can be done via a designated online portal of the Central Government for a loan license to produce or distribute Class C and Class D Medical Devices. This application uses Form MD-8 to acquire the License in FORM MD-10. Typically, the loan license takes 4-6 months to be issued after the application is submitted.
    Form-MD-8-10

    Who Can Apply?

    The application is open to any manufacturer of Medical Devices in India.

    Endorsement of Loan License MD-8, MD-10

    How To Apply?

    The Applicant must follow the following process:

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      Verify the existing loan manufacturing license details.
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      The second step in the application process is to draft it.
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      Verify the existing loan manufacturing license details.
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      Upload the necessary documents in accordance with the MD-8 checklist.
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      Pay the government fee for the application.
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      Submit the application.
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    Validity

    A Form MD-10 license stays valid forever if the license retention fee is paid within five years from its issue date, as per the Second Schedule. However, the license can be suspended or canceled by the Central Licensing Authority.
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    Fee Involved

    There is a government fee of Rs. 1000 for the loan license application process for each distinct medical device of class C or class D.

    Important Documents

    Important Documents
    During the documentation process, the following documents should be present:
    • QMS documents
    • Device Master File

    Timeline to get MD 10 from Central Drugs Standard Control Organisation

    4-6

    Months

    Essential Tips

    When drafting and submitting this license application, the following are the main things to keep in mind:
    • The applicant's manufacturing facility must meet the Quality Management System (QMS) requirements. They are outlined in the Fifth Schedule.
    • Device master files and site master files must be ready in accordance with MDR 2017 format.
    The obstacle that is most likely to arise when filling out the manufacturing license is:
    • Failure of product technical documentation to comply with MDR 2017.
    • The absence of a license from the principal manufacturer as per MDR 2017.
    Expert Advise

    According to our experts, the manufacturers must generate the quality control data using a valid test license at the time of application submission.

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    Frequently Asked Questions

    When can one expect an inspection by CDSCO for the manufacturing site of class C and D Medical Devices?

    The applicants can expect the inspection by CDSCO within sixty days from the date of submission of the application.

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

    A minimum of two Medical Device officers, which may also include an officer senior to the Medical Device officer, with or without an expert or a notified body, make up the inspection team.

    If a loan facility is a licensed manufacturing plant, will there be a re-inspection in this case?

    If an IVD manufacturing facility already has a license to produce the Medical Device for sale or distribution, no inspection of the facility is necessary to award a loan license to manufacture the device.