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Endorsement of Predicate In Vitro Diagnostics in Loan License in India - MD-04 & MD-06


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    CliniExpert-usp test license

    Unlock manufacturing excellence with CliniExperts! Secure your MD-06 Loan License for Class A/B 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 provisions of In-Vitro Diagnostics Medical Devices Rules, 2017, a license is issued by SLA or CLA. It allows new manufacturers to make IVDs at another licensee's manufacturing site, making the same device as the licensee. CDSCO (Central Drugs Standards Control Organization) has notified that:
    • Form MD-04 (Application for Grant of Loan License to Manufacture for Sale or Distribution of Class A or Class B Medical Device) must be submitted.
    • Form MD-06 (Loan License to Manufacture for Sale or Distribution of Class A or Class B Medical Device) must be approved. The license normally takes 4-5 months to obtain after submission of the application.
    form md 4 md 6

    Who Can Apply?

    A manufacturer who wants to manufacture in vitro diagnostics medical devices is eligible to apply.

    Permission of Predicate In-Vitro Diagnostics Kit Loan License In India

    How To Apply?

    The Applicant must follow the following process:

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      For the first time applicants, the manufacturer must log on to the Sugam portal and submit the application.
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      The manufacturers who are willing to apply for the loan license are required to submit an endorsement application. This is done on the Sugam portal for an already submitted application.
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    Validity

    Unless it is suspended or revoked by the SLA, the manufacturing license in Form MD-06 will remain valid indefinitely. It is subject to the payment of the license retention fee as stipulated in the second schedule. This must be done before the completion of five years from the date of issuance.

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    Fee Involved

    The government charges for the loan license for classes A and B are:
    • One site: Nil
    • Each distinct medical device: ₹500
    The government charges for the loan license for classes C and D are:
    • One site: Nil
    • Each distinct medical device: ₹1000

    Important Documents

    Important Documents
    The documents mentioned below should be present during the documentation process:
    • Wholesale License
    • Device Master File
    • Site Master File
    • QMS

    Timeline to get MD-06 from Central Drugs Standard Control Organisation

    4-5

    Months

    Essential Tips

    The primary considerations that need to be made while submitting this loan license application are:
    • Manufacture must hold the manufacturing license before filing the loan license endorsement application.
    • The obstacles or issues that are most likely to arise when filling out the forms and can be easily avoided are:
    • The application must be filed using the MDR-2017 prescribed format.
    • All technical documents, including device master files and site master files, must adhere to the format specified in MDR 2017.
    Expert Advise

    According to our experts, clients should look out for the following the license application procedure:

    There must be alignment between the product name, model number, label, IFU, and other technical documentation.

    For grouping products, it is vital to adhere to the grouping guidelines on medical devices issued by the MoHFW, Government of India. If you fail to do the needful, you may be charged additional fees by the Government.

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    Frequently Asked Questions

    Whether Specimens collection tubes (vacuum type or not) without needle used for the collection of Blood, Urine, Stool, Sputum, Semen, etc., for purpose of specimens collection are being regulated under the provision of Medical Devices Rules, 2017?

    Specimen collection tubes are regulated under the definition of specimen receptacle‖ as specified in Sub-clause (zs) of Rule 3 of MDR-2017 and are classified as Class A as per First Schedule, Part II (2(v)(3)) of MDR-2017.

    Whether IVDs for HBsAg, HIV and HCV approved to manufacture or import by the CLA or SLA, as the case may be, permitted to use for both the purposes; for blood screening and diagnostic.

    Yes. In – Vitro Diagnostic devices for HBsAg, HIV and HCV manufactured / Imported under valid license issued by the CLA or SLA, may also be used in Blood Bank, as the criteria like Sensitivity (%) and Specificity (%) for evaluation of the HBsAg, HIV and HCV diagnostic kits for the Transfusion purpose (Blood Banks) and Diagnostic purpose are same, Provided the manufacturer claims in the product labels or in the IFU that the product is intended both the purposes; for blood screening and diagnostic.

    What is the fee structure required for multiple Brand names of a product applied in the manufacturing/ import licence application?

    For multiple brand names of a product, the firm needs to submit applicable product fee as per Second schedule for each of the Brand name.

    Who will have the responsibility of doing Classification of IVD as per Class A/B/C/D?

    Reference Rule 4 (3) This rule specifies that Central Licensing Authority shall classify the Medical Devices.

    Whether on market approved products, in India have to be newly registered as per Medical Devices Rules, 2017, when the existing license gets expired?

    Yes, IVD products which are currently registered in India have to be registered according to the provisions of Medical Devices Rules, 2017.