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:
o Establishment/Site
ownership/Tenancy Agreement
o Test License obtained from
CDSCO (ensuring its validity)
o QMS Certificate (verifying
compliance with Quality Management System)
o Plant Master File (detailed
information about the manufacturing facility)
o 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.
-
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!
