MD-10 refers to the form used to grant a Loan
License to Manufacture for Sale or for Distribution of Class C or Class
D medical devices in India. It’s important to understand that the
application itself is submitted through a different form, MD-8.
Here’s a breakdown of the two:
- MD-8: This
is the application form for the Loan License. It’s filled out and submitted
electronically through the online medical device portal for Class C and
Class D devices.
- MD-10: This
form represents the official Loan License itself, which is issued by the
Central Licensing Authority (CLA) upon approval of your application
(MD-8).
Who Needs MD -10
An application for an MD-10 Loan License
(granted through Form MD-10) can be submitted by any person or company who
wishes to manufacture Class C or Class D 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 C or D devices.
·
The
manufacturer who lacks their own manufacturing facility but desires to produce
Class C or Class D medical devices.
Benefits of Obtaining MD-10
Here’s a breakdown of the benefits:
- Increased Production: Companies
can leverage existing licensed facilities to scale up production and meet
market demands for high-risk devices.
- Reduced Costs: This
approach avoids the significant capital expenditure required to set up a
new manufacturing unit specifically for Class C or D devices, which often
have more stringent infrastructure requirements.
- Faster Time to Market: By utilizing an existing facility that already
meets the complex regulatory demands for Class C and D devices, companies
can potentially bring their products to market quicker.
- Scalability: Easily
adjust production based on demand by contracting with a loan facility that
has the capacity for Class C/D manufacturing.
- Flexibility: Suitable
for companies needing temporary or occasional production boosts for their
higher-risk medical devices.
How to Obtain MD-10 Loan License in India?
Obtaining an MD-10 Loan License in India
involves several steps. Here’s a simplified breakdown of the process:
1. User Registration:
o Register your organization
on the Central Drugs Standard Control Organization’s (CDSCO) MD Online Portal.
2. Application Preparation (Form MD-8):
o Fill out the application
form MD-8, which details your request for the Loan License for Class C or Class
D medical devices.
3. Document Compilation:
o Gather the necessary
documents as per the MD-8 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, e.g., ISO 13485)
§ Plant Master File (detailed
information about the manufacturing facility)
§ Device Master File
(comprehensive data on the specific medical devices)
§ Agreements between the loanee
and loan licensor.
4. Fee Payment:
o Pay the requisite
government fees associated with the Loan License application. This includes a
base fee and potential additional fees per device type.
5. Online Submission:
o Submit your completed application
(MD-8) along with the required documents through the online medical device
portal.
6. Audit by Notified Body:
o The Central Licensing
Authority (CLA) will appoint one of the notified bodies from the list of
approved notified bodies to audit the premises of the actual manufacturing
site. The notified body will audit the actual manufacturing site and will
submit their audit report to the CLA.
7. Scrutiny and Approval:
o The Central Licensing
Authority will review your application, audit report submitted by the notified
body, and submitted documents. This scrutiny is often more rigorous for Class C
and D devices due to their higher risk classification.
8. Granting of MD-10 (License):
o Upon successful review and
approval, the Central Licensing Authority will issue the official MD-10 Loan
License.
Streamlined Process with MDR Consultant
Expertise:
- In-depth Knowledge: MDR
consultants have in-depth knowledge of the Medical Devices Rules (MDR)
2017 and the Loan License application process (MD-8 and MD-10).
- Manageable Steps: MDR
can break down the complex process into manageable steps and ensure you
complete everything accurately and on time, particularly crucial for the
stringent requirements of Class C and D devices.
- Compliance Assurance: MDR
consultants can review your application and documents to identify any
potential issues related to MDR 2017 compliance, especially regarding
quality management systems and technical documentation for higher-risk
devices.
- Proactive Correction: MDR
can advise on necessary corrections or adjustments to avoid delays during
the Central Licensing Authority’s review, which can be prolonged for Class
C and D device applications.
- Documentation Expertise: MDR consultants can assist with preparing complex
technical documents like Device Master File and Site Master File according
to the specific MDR 2017 format for Class C/D devices. They can also help
compile the necessary supporting documents required for your MD-8
application.
- Effective Communication: MDR consultants can act as a bridge between you
and the Central Licensing Authority. We can facilitate clear
communication, address any questions that may arise during the process,
and ensure a smooth application experience for these critical device
classifications.
