Permission for Loan License to Manufacture Class C & D Medical Devices in India - MD 8 & MD 10
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 for loan license 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.
Who Can Apply?
Any manufacturer who wishes to manufacture Class C and D devices can apply for loan license
How To Apply?
The Applicant must follow the following process:
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Step 1: Sugam Registration of the applicant
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Step 2: Drafting of Application
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Step 3: Uploading all the documents according to checklist of the form MD-8
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Step 4: Processing of the mandatory government fee
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Step 5: Submitting the application on online Medical Device portal
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.
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
Important Documents
- Device Master File
- Site Master File
- QMS Documents
Timeline to get
MD 10
from Central Drugs Standard Control Organisation
4 to 5
MONTHSEssential 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.
Related Services
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.