Loan Licenses for Manufacturing Class C & D Medical Devices (Forms MD-8, MD-10)

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:     

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

2. Application Preparation (Form MD-8):

• 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:

• 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:

• 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:

• Submit your completed application (MD-8) along with the required documents through the online medical device portal.

6. Audit by Notified Body:

• 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:      

• 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):        

• 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.