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LOAN LICENCE TO MANUFACTURE FOR SALE – MD10

Seamless (MD10) Loan License Support for Class C & D

Looking for a Loan license in India? Medfins provides strategic guidance and complete support to help you secure CDSCO approval under the MD-10 pathway.

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What is MD10?

MD10 – “Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device Loan Licence” in India

This is the actual permission or license issued by CDSCO after they have successfully evaluated and approved your MD-8 application.

It is applicable for Class C & D medical devices and the license is valid for 5 years from the date of issue.

Latest updates or deadlines (if any)
Currently, all Class C & D medical devices must comply with MD10 licensing under
the revised MDR 2017.

Services We Offer Under MD10

Break down your offerings as a list or grid:

  • ️ Device Classification
  • ️ Loan License Documentation Preparation
  • ️ Communication Support with Central License Authority
  • ️ Device Master File (DMF) & Plant Master File (PMF) Preparation
  • ️ Post-submission Query Handling
  • Successful Licensing Support

Struggling with MDR compliance? Let Medfins guide
you through.

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Why Choose Medfins for MD10 Compliance?

  • Specialized expertise in CDSCO Regulations.
  • Deep understanding of CDSCO expert committee processes
  • Regulatory documentation capabilities
  • Strategic approach to complex regulatory pathways
  • Established relationships with CDSCO and expert committees
  • End-to-end support from concept to market authorization

Step-by-Step Process

Visual timeline or steps:

  • Initial Device Assessment
  • Collection of documents from Original Equipment Manufacturer
  • Gap Analysis of Existing Data
  • Preparation of pending documents
  • Verification of documents as per the checklist provided by CDSCO
  • Submission of Application under Form MD-8(Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D)
  • Loan License Coordination & Agreements
  • CDSCO Evaluation and query handling
  • Approval and Issuance of MD-10 Import License

The forms required for Manufacturing License in case of class A and B notified medical devices:

Applicant type

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

Fee Structure:

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

FAQ

What documents are required for MD-10 application?
● Agreement with the licensed manufacturer
● Device Master File (DMF)
● Plant Master File (PMF)
● ISO 13485:2016 certificate
● Valid MD-9 license of the third-party manufacturer
● Product specifications and labeling details

Yes, ISO 13485:2016 compliance is mandatory for the manufacturing site

Yes, CDSCO may inspect the third-party manufacturer’s site to ensure QMS compliance.

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With our expertise and commitment, you can expect exceptional support for all your regulatory compliance needs.
How this works?
  • Fill out the registration form
  • Schedule a consultation
  • Meet with our regulatory expert
  • Receive tailored guidance
  • Make payment online or via invoice
  • Your project will be initiated by our Executive team

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