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.
A manufacturer can submit the application for permission to manufacture Class C and D IVD's through Form MD-8.
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. |
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.
The necessary documents for the application are
MD-10from Central Drugs Standard Control Organisation
4 to 5
MONTHSEnsure that quality control data is generated based on valid test license while submitting the application.
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.
Yes, CDSCO may re-inspect the loan manufacturing facility.
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.