Loan Licenses for Manufacturing Class A &; B Medical Devices (Forms MD-4, MD-6)

MD 6 refers to the form used to grant a Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical devices in India. It’s important to understand that the application itself is submitted through a different form, MD-4. Here’s a breakdown of the two:

• MD-4: This is the application form for the Loan License. It’s filled out and submitted electronically through the online medical device portal.
• MD-6: This form represents the official Loan License itself, which is issued by the State Licensing Authority upon approval of your application (MD-4).

Who Needs MD -6

An application for an MD 6 Loan License (granted through Form MD-6) can be submitted by any person or company who wishes to manufacture Class A or Class B medical devices in India. This includes:

·         Start-ups or companies new to medical device manufacturing that don’t have their own facilities but want to produce Class A or B devices.

·         The manufacturer who lacks their own manufacturing facility but desires to produce Class A or Class B medical devices.

Benefits of Obtaining MD-6

Here’s a breakdown of the benefits:

• Increased Production: Companies can leverage existing licensed facilities to scale up production and meet market demands.
• Reduced Costs: This approach avoids the significant capital expenditure required to set up a new manufacturing unit.
• Faster Time to Market: By utilizing an existing facility, companies can potentially bring their products to market quicker.
• Scalability: Easily adjust production based on demand by contracting with a loan facility.
• Flexibility: Suitable for companies needing temporary or occasional production boosts.

How to Obtain MD 6 Loan License in India?

Obtaining an MD 6 Loan License in India involves several steps. Here’s a simplified breakdown of the process:

1. User Registration:

• Register your organization on the Central Drugs Standard Control Organization’s CDSCO MD Online Portal.

2. Application Preparation (Form MD-4):

• Fill out the application form MD-4, which details your request for the Loan License.

3. Document Compilation:

• Gather the necessary documents as per the MD-4 checklist. These typically include:
• Establishment/Site ownership/Tenancy Agreement
• Test License obtained from CDSCO (ensuring its validity)
• QMS Certificate (verifying compliance with Quality Management System)
• Plant Master File (detailed information about the manufacturing facility)
• Device Master File (comprehensive data on the specific medical devices)

4. Fee Payment:

• Pay the requisite government fees associated with the Loan License application. This includes a base fee and potential additional fees per device.

5. Online Submission:

• Submit your completed application (MD-4) along with the required documents through the online medical device portal.

6. Audit by Notified Body:

• SLA will appoint the one the notified body from the list of approved notified body to audit the premises of actual manufacturing site. Notified body will audit the actual manufacturing site and will submit their audit report to SLA.

7. Scrutiny and Approval:

• The State Licensing Authority will review your application, audit report submitted by notified body and submitted documents.

8. Granting of MD-6 (License):

• Upon successful review and approval, the State Licensing Authority will issue the official MD-6 Loan License.

Important Tips:

• Ensure your manufacturing site adheres to the QMS requirements outlined in the Fifth Schedule of the Medical Devices Rules (MDR) 2017.
• Prepare both the Device and Site Master Files following the MDR 2017 format for accurate documentation.

MDR consultants act as your expert guides throughout the process of acquiring an MD 6 Loan License. Their role is crucial in navigating the complexities and ensuring a smooth application journey. Here’s how they can help:

Streamlined Process:

• MDR consultants have in-depth knowledge of the Medical Devices Rules (MDR) 2017 and the Loan License application process (MD-4 and MD-6).
• MDR can break down the process into manageable steps and ensure you complete everything accurately and on time.
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Compliance Assurance:

• MDR consultants can review your application and documents to identify any potential issues related to MDR 2017 compliance.
• MDR can advise on necessary corrections or adjustments to avoid delays during the State Licensing Authority’s review.

Documentation Expertise:

• MDR consultants can assist with preparing technical documents like Device Master File and Site Master File according to the specific MDR 2017 format.
• MDR can also help compile the necessary supporting documents required for your MD-4 application.

Effective Communication:

• MDR consultants can act as a bridge between you and the State Licensing Authority.
• We can facilitate clear communication, address any questions that may arise during the process, and ensure a smooth application experience.

Call to Action:

Obtaining an MD 6 Loan License can be a complex process, but MDR consultants can significantly improve your chances of success. To get a free quote and discuss your specific needs, call us today!