Retention of Loan Manufacturing License for Class A and B Medical Devices in India - MD 4 & MD 6
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Retention of Loan Manufacturing License- Form MD 4/6 (Class A and B) – Overview
The regulatory body responsible for retention of loan manufacturing license (Class A and Class B) is the State FDA. Any person who intends to retain their loan manufacturing license (MD 6) shall make an application to the State Licensing Authority through an online portal of the Ministry of Health and Family Welfare in the Central Government. This service is required to retain the loan manufacturing license of Class A and Class B medical devices granted in Form MD 6.
Who Can Apply?
- Any person intending to manufacture Class A and Class B medical devices through a loan license.
How To Apply?
The Applicant must follow the following process:
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It has to be applied to the State Licensing Authority through an online portal of the Ministry of Health and Family Welfare in the Central Government.
Validity
Fee Involved
The fees required for the loan manufacturing license for:
- One site manufacturing Class A or Class B in-vitro diagnostic medical device – INR 5000
- Each distinct in-vitro diagnostic medical device of Class A or Class B – INR 500
Important Documents
- A copy of the existing loan manufacturing license (MD 6) for which retention is applied.
- An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Plant Master File (PMF) and Device Master File (DMF).
- Documents stating the qualifications, experiences and responsibilities of current competent technical staff.
Timeline to get
MD 6
from Central Drugs Standard Control Organisation
1 to 2
MONTHSEssential Tips
The documents required for the loan manufacturing license (Class A and Class B) application, preparation and submission are:
- A copy of the existing loan manufacturing license (MD 6) for which retention is applied.
- Post marketing surveillance data (Details of complaints, AEs, SAEs, sales, Recall, CAPA, if any)
- Documents stating the qualifications, experiences and responsibilities of current competent technical staff.
Expert Advise
An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Constitution of the Firm must be submitted.
An undertaking duly signed and stamped with a designation from the manufacturer stating that there is no change in the Plant Master File (PMF) and Device Master File (DMF) also must be submitted.
The license holder needs to pay the loan manufacturing license retention fee on or before the due date.
Frequently Asked Questions
Can the license holder pay the manufacturing license retention fee after the due date?
If the license holder pays the manufacturing license retention fee after the due date, then they must pay a late fee calculated at the rate of 2% of the manufacturing license retention fee for every month or part thereof, within 180 days, along with the manufacturing license retention fee.
Is post marketing surveillance data required for the retention of the application?
Yes, the post marketing surveillance data is required.
