Permission for Loan License to Manufacture Class C & D In-Vitro Diagnostics in India - MD-8 & MD-10
CliniExperts can assist in fulfilling all the requirements of CDSCO. The professionals at CliniExperts provide comprehensive support throughout the application process. They assist in the submission of Form MD-8 for manufacturing Class C and Class D IVDs. The experts are updated with latest CDSCO guidelines, ensuring swift approvals without obstacles.
Permission for Loan License to Manufacture Class C & D In-Vitro Diagnostics – Overview
Central Drugs Standard Control Organization (CDSCO) oversees the manufacturing of Class C and D IVDs. Any manufacturer intending to manufacture Class C & D (Notified) IVDs requires a Loan manufacturing license in FORM MD-10, as per MDR, 2017.
The application process takes about four to five months. A manufacturer must apply to the CLA through an online portal for a Loan license to manufacture for sale or distribution Class C & Class D IVD in Form MD-8. Subsequently, they can obtain the license in FORM MD-10.
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?
The Applicant must follow the following process:
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Step 1: Online registration of the applicant at the SUGAM registration portal.
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Step 2: Drafting the online application in prescribed proforma.
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Step 3: Uploading the documents as per the checklist of Form MD-8.
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Step 4: Paying the requisite Government Fee.
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Step 5: Submission of application on medical device portal.
Validity
A license issued in Form MD-10 has life-long validity. They are valid forever subject to the timely payment within 5 years of the issue date. However, they could get suspended or cancelled upon failure in payment by the Central Licensing Authority.
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 D for one site of manufacturing medical devices is INR 50000, whereas each distinct Medical Device costs INR 1000.Important Documents
The necessary documents for the application are
- Device Master File
- Site Master File
Timeline to get
MD-10
from Central Drugs Standard Control Organisation
4 to 5
MONTHSEssential Tips
The essential things to keep in mind during the application preparation and submission process:
- Manufacturing site must adhere to Quality Management System requirements outlined in Fifth Schedule.
- The Device Master files and site master files must be prepared as per the format for Medical Device Rules, 2017.
- The technical documents of the products must align with the MDR 2017. Otherwise, the manufacturers may face delays or other issues during the application process.
Expert Advise
Ensure that quality control data is generated based on valid test license while submitting the application.
Related Services
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?
Yes, CDSCO may re-inspect the loan 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.