Permission for Loan License to Manufacture Class C & D Medical Devices in India – MD 8 & MD 10


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    Loan License To Manufacture Class C & D Medical Devices helps you to increase the production of existing notified medical devices and achieve new heights in business. CliniExperts helps you sail through the paperwork and obtain the permission to manufacture medical devices for class C & D via Form MD – 8 and Form MD – 10 in no time!

    Permission for Loan License to Manufacture Class C& D Medical Devices– Overview


    According to the Medical Devices Rules, 2017, a Loan License To Manufacture Class C & D Medical Devices in Form MD-10 is required to manufacture notified medical devices in India. These loan license applications are filed in Form MD-8, which is used to obtain the licenses in Form MD-10.

    In order to obtain a loan license to manufacture Class C & Class D medical devices, the manufacturer has to make an application to the Central Licensing Authority via an online portal of the Central Government. It takes between 4-5 months to complete the process.

    CDSCO - Authorized Agent Support - Medical Device

    What is MD 8 and MD 10

    Form Names

    MD 8:

    Application for grant of loan license to manufacture for sale/ distribution of Class C or Class D medical device

    MD 10:

    Loan License to manufacture for sale or for distribution of Class C or Class D Medical Device

    Who Can Apply?


    Any manufacturer who wishes to manufacture Class C and D devices can apply for loan license


    How To Apply?

    Step 1: Sugam Registration of the applicant
    Step 2: Drafting of Application
    Step 3: Uploading all the documents according to checklist of the form MD-8
    Step 4: Processing of the mandatory government fee
    Step 5: Submitting the application on online Medical Device portal

    Fee Involved

    Government fee for Manufacturing license or loan license to manufacture Class C or Class D medical device is :

    (a) one site: 50000

    (b) each distinct medical device: 1000

    Validity

    A license issued in Form MD-10 will remain valid permanently, as long as the retention fee as specified in the Second Schedule is paid before completion of five years from the date of issue, unless the Central Licensing Authority suspends or cancels the license.

    Important Documents

    Device Master File Site Master File QMS Documents

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

    The Government timeline to get Loan License for Manufacturing Class C & D Medical Devices is 4-5 Months.

    Essential Tips

    The applicant's manufacturing site must comply with the requirements of the Fifth Schedule of the Quality Management System.


    Device master files and site master files must be prepared according to MDR 2017 format.

    Expert Advise

    The quality control data must be generated based on a valid Test License when the application is submitted.

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    Frequently Asked Questions

    What is the CDSCO's schedule for inspecting the manufacturing site of Class C and D medical devices?

    The CDSCO inspects the manufacturing site of class C and D medical devices within sixty days from the date of submission of application.

    Will there be a re-inspection of a loan license facility if the loan facility is a licensed manufacturing facility?

    It is not necessary to inspect a manufacturing site for grant of a loan license to manufacture the medical device if the manufacturing site is already authorized to manufacture the device for sale or distribution.

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

    A team with at least two Medical Device Officers, which may also include any senior officer with or without an expert or a Notified Body.

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