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Licence to Import Medical Device – MD15

Expert Assistance for MD-15 Import Registration in India

Looking to import a medical device into India? Medfins simplifies the process and ensures fast, compliant registration through CDSCO’s MD-15 pathway.

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What is MD-15?

The MD-15(Licence to Import Medical Device), issued by the Central Drugs Standard Control Organisation (CDSCO), is a mandatory import license required for bringing medical devices into India. This license signifies that your imported medical device meets all Indian regulatory standards for safety, quality, and performance. The MD-15 license is applicable for all Classes of Medical Device(Class A,B,C and D) and typically valid for five years from the date of issuance.

Services We Offer Under MD-15

Break down your offerings as a list or grid:

  • ️ Device Classification & Scope Assessment
  • Assistance in License Requirements Mapping
  • ️ Documentation Review and Compilation
  • ️ CDSCO Portal Registration & Application (Form MD-14)
  • ️ Query Management & CDSCO Liaison
  • ️ Hassle-free MD-15 License Approval

Struggling with MDR compliance? Let Medfins guide
you through.

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Why Choose Medfins for MD-15 Compliance?

  • In-depth knowledge of India’s medical device import regulations
  • Expertise in handling documentation aligned with Regulatory standards
  • Strong coordination with Indian authorized agents and CDSCO officials
  • Dedicated team for technical and regulatory documentation
  • 100% compliant submission support
  • Timely resolution of CDSCO queries and gaps

Step-by-Step Process

Visual timeline or steps:

  • Initial Device Assessment and classification as per Indian Medical Device Rules, 2017
  • Collection of documents from Original Equipment Manufacturer
  • Gap Analysis
  • Preparation of pending documents
  • Verification of documents using CDSCO Checklist
  • MD-14(Application for issue of import licence to import medical device) Submission
  • CDSCO Review & Resolution of Query raised by officials
  • MD-15 License Issuance

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

In case of multiple importers for same product, do all the documents related to site and product need to be submitted?
The subsequent applicant (new agent) has to submit the documents viz. Form MD-14, Power of Attorney, Free sale certificate, requisite fees, wholesale license/ Form MD-42/ manufacturing license, Label, IFU and copy of import licence issued to earlier authorized agent along with the undertaking from the manufacturer stating that there is no change in the Device master file, Plant master file, under MDR-2017.

 As per Medical Devices Rules, 2017, the timeline for grant of Import license

is nine months, provided the documents are found satisfactory.

Yes. Change in Indian agent will require Fresh Import License.

 

Yes.

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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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