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.
Any manufacturer who wishes to manufacture Class C and D devices can apply for loan license
|Step 1: Sugam Registration of the applicant|
|Step 2: Drafting of Application|
|Step 3: Uploading all the documents according to checklist of the form MD-8|
|Step 4: Processing of the mandatory government fee|
|Step 5: Submitting the application on online Medical Device portal|
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.
The Government timeline to get Loan License for Manufacturing Class C & D Medical Devices is 4-5 Months.
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.
The quality control data must be generated based on a valid Test License when the application is submitted.
The CDSCO inspects the manufacturing site of class C and D medical devices within sixty days from the date of submission of application.
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.
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.