The regulatory body involved in overseeing the manufacturing of Class C and D IVD's is the Central Drugs Standard Control Organisation (CDSCO). A Loan manufacturing license in FORM MD-10 is needed by any manufacturer, as per provisions of the Medical Device Rules, 2017 for manufacturing the IVD's of Class C & Class D (Notified) in India.
The application process takes about four to five months. A manufacturer must apply to the Central Licensing Authority through an identified online portal of the Central Government for a Loan license to manufacture for sale or distribution Class C & Class D IVD in Form MD-8 to 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.
|Step 1: Online registration of the applicant at the SUGAM Registration portal.|
|Step 2: Drafting the online application in prescribed proforma|
|Step 3: Uploading the documents as per the checklist of Form MD-8|
|Step 4: Paying the requisite Government Fee|
|Step 5: Submission of application on Online medical device portal|
A license issued in Form MD-10 has life-long validity. They are valid forever subject to the timely payment within five years of the issue date or could get suspended/ cancelled upon failure in payment by the Central Licensing Authority.
The timeline to obtain Loan License for Manufacture Class C and D IVD's is 4-5 months.
The essential things to keep in mind during this license application preparation and submission process:
The applicant’s manufacturing site should comply with the requirements of the Quality Management System as specified under the Fifth Schedule.
The Device Master files and site master files must be prepared per the format for Medical Device Rules, 2017.Manufacturers might face delay in receiving license or other problems during the application filing process if-
The technical documents of the products are not in line with the MDR 2017.
The principal manufacturer does not have a license as per the MDR 2017.
The professionals at CliniExperts advise their clients that while submitting the application, the quality control data must be generated on the basis of a valid Test License.
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?
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.