For all the manufacturers in India, MD 6 loan license is mandatory. To start your medical device journey as a manufacturer in India MD 6 loan license for medical device manufacturer registration is necessary. Without this license, you are not allowed to manufacture any kind of medical products in India.
What Is MD 6 Loan License?
MD 6 loan license is a mandatory authorized document for the medical device manufacturer. The certification is mandatory for those who intend to manufacture Class A & B medical devices and in-vitro Diagnostic devices on loan premises.
Who Needs An MD 6 Loan License In India?
The MD 6 loan license is required for any medical device manufacturer. The loan license is mandatory for those who want to utilize the manufacturing facilities of another licensed manufacturer and producer. This is mandatory for the manufacturing of devices of Class A & B and in-vitro diagnostics devices. This license allows the manufacturer to increase the production capabilities and the manufacturer no need to invest dedicatedly in the manufacturing facility.
What Are The Benefits of MD 6 Loan License In India?
The MD 6 loan license has multiple benefits for medical device manufacturers license in India. You can simply explore a few of them below:-
Expand The Production Capacity
Without any significant capital investment, manufacturers can increase the product capacity of medical devices.
If you are utilizing the existing manufacturer facility then it reduces the cost of production as compared to the new facility establishment.
Acquire Market Quickly
If you are using the existing infrastructure, then you can acquire the market of medical devices more quickly.
How Can You Apply For The MD 6 Loan License Medical Device?
If you are willing to apply for the medical device loan license in India then you have to follow the simple process. With the help of this process you can simply register your medical device company for a loan license:-
Registration On SUGAM Portal Of CDSCO
Register your business or company under the SUGAM Portal Of CDSCO Registration. You have to submit the following documents during the time of registration such as Identity proof, Address Proof, and other required documents.
Fill Out The Application Form MD 4
Then fill in the application form MD 4 and fill in the necessary information. In the form, you have to fill in the information of the list of devices you want to manufacture, the device’s generic name, trade name, description, intended use, shelf life, storage condition, model number, etc.
Upload Mandatory Documents
You have to attach mandatory documents such as the site master file, device master file, and MD 5 License copy of the actual manufacturer.
Pay The Fees
After filling out the file you have to submit the fee for the loan license and per distinct medical device.
Scrutiny Loan License Application
Make sure that your application is scrutinized by the State Licensing Authority. They can ask for more documents if they need it.
Audit Of documents and Business By notifying Body
Your loan license application will undergo a quality management system compliance audit upon meeting the necessary criteria. An independent notified body sanctioned by the CDSCO will audit your facilities. In the event of any Non-Conformance (NC) findings, you’ll need to provide an NC closure report.
Approval of MD-5 License
When it find all the documents correct they will grant the license MD 6 Loan License to manufacture Class A or Class B Medical Devices.
List Of Mandatory Documents For MD 6 Loan License For Medical Device
To fill in the form you have to attach a few documents in India for the MD 6 loan license for Medical Device:-
- Application Form MD 4
- Site master file
- Device master file
- ISO 13485 Certificate
- Receipt of the Fee
- MD 5 License copy of the Actual Manufacturer
What Is The Validity Of Loan License?
The loan license for medical devices is valid for 5 years and you have to pay a fee in the perpetual year for the renewal of the loan license in India.
What Is The Timeline To Get a Loan License?
The loan license for medical devices takes at least 3 to 6 months.
Why Choose Medical Device Registration Services For a Loan License?
At Medical Device Registration you will find better solutions and expert guidance for loan license registration. We will provide you the following services:-
- Application Preparation – We will assist you in completing the application process and how to process and fill the application. If you find any difficulty then we will apply on your behalf.
- Completion and Review Of Documents – We will help you and guide you to check what kind of documents you have to attach for the completion of documents.
- Experts Guidance & Representation – On MDR you will get expert guidance that will help you to verify your application.