Import License for Predicate Medical Devices (Forms MD-14, MD-15)

What is an MD-15 License?

 MD-15 license is an import license issued by the Central Drugs Standard Control Organization (CDSCO) in India, authorizing the import of medical devices (Class A, B, C, or D) into the country. It essentially permits the legal sale and distribution of these imported devices within the Indian market.

The Central Drugs Standard Control Organization (CDSCO) has implemented a simplified system for importing medical devices into India. This applies to all classes of medical devices, regardless of whether they are Class A (measuring/sterile), Class B, Class C, or Class D.

Who Needs an MD-15 License?

• Indian Importers: Companies in India that import medical devices require an MD-15 license.
• Authorized Indian Agents: Foreign manufacturers must appoint an authorized Indian agent who obtains the MD-15 license on their behalf. This agent acts as a liaison between the manufacturer and the CDSCO.

Benefits of Obtaining an MD-15 License:

• Legality: Ensures compliance with Indian regulations for importing and selling medical devices.
• Market Access: Allows you to import and commercialize your medical devices in the Indian market.
• Credibility: Demonstrates adherence to quality standards and strengthens trust with Indian customers.

CDSCO Import License for Medical Devices (MD-14) Checklist Summary

This checklist summarizes the documents required for applying for an MD-14 form, which is necessary to obtain a CDSCO import license for medical devices in India. The checklist is divided into two sections: Fresh Application and Endorsement.

Fresh Application

• General Documents: Covering letter, fee challan, application form (MD-14).
• Authorization: Power of attorney from the manufacturer to the authorized agent, along with relevant undertaking.
• Applicant Information: Copies of relevant licenses/registration certificates for the authorized agent and their constitution details.
• Device Information: Regulatory certificates, free sale certificates/marketing authorizations, details of the manufacturing site, and any recent inspection reports.
• Quality Certificates: Documents demonstrating the manufacturer’s quality management system compliance.
• Device Master File (Manufacturer): Comprehensive technical documentation of the medical device, including design information, risk analysis, labeling, and performance data. This may include:
• Executive summary
• Device description
• Justification for device grouping
• Product specifications
• Labeling information
• Design and manufacturing information
• Essential principles checklist
• Risk analysis and control summary
• Verification and validation data
• Biocompatibility data (if applicable)
• Medicinal substances data (if applicable)
• Biological safety data (if applicable)
• Sterilization validation data (if applicable)
• Software verification and validation data (if applicable)
• Animal studies data (if applicable)
• Stability study data
• Clinical evidence (if applicable)
• Post-marketing surveillance data
• Batch release certificates

Endorsement

This section applies if you are seeking an endorsement for an existing import license. The documents required are similar to a fresh application, but with some exceptions:

• You only need to provide a copy of the existing import license for which the endorsement is requested.
• Device Master File for the product for which endorsement is applied.
• Product registration incurs a fee, site registration is free.

Additional Notes

• All documents submitted in a foreign language must be duly notarized and translated into English.
• This summary is for general information purposes only. It is recommended to consult the official CDSCO guidelines for the latest and most accurate requirements.

Process for Obtaining an MD-15 License (Key Points):

1. Application (Form MD-14): The authorized Indian agent submits an online application (Form MD-14) on the CDSCO web portal.
2. Create Legal form by providing details about your device’s generic name, intended use, materials of construction, risk classification (Class A-D), and shelf life to ensure compliance with Indian regulations.
3. Document Upload: Upload necessary documents (check the above checklist for necessary documents.)
4. Fee Payment: Pay the prescribed government fee as per Second Schedule (MEDICAL DEVICE RULES- GSR 78E-IMDR 2017.
5. CDSCO Review: SLA will review all the necessary documents.
6. MD-15 Grant (if approved): Upon successful review and potential inspection, the CDSCO issues the MD-15 import license to the authorized agent.

Validity:

The MD-15 license is valid for 5 years from the date of issue. However, it requires renewal every 5 years with payment of a retention fee.

MDR Consultants: Your’ Partner in Securing MD-15 License

Obtaining a CDSCO MD-15 import license for medical devices in India can be a complex process. MDR (Medical Device Regulation) consultants can be invaluable assets in navigating this process and increasing your chances of success. Here’s how MDR consultants can play a crucial role in securing your MD-15 license:

Expertise in Medical Device Regulations (MDR):

• Consultants possess in-depth knowledge of the latest MDR guidelines and their application to the MD-15 licensing process.
• We can ensure your application adheres to all relevant regulations, avoiding potential delays or rejections.

Streamlined Application Process& Gap assessment:

• MDR consultants can guide you through each step of the application, from gathering necessary documents to completing the online form (MD-14).
• We can help ensure all documentation is accurate, complete, and formatted correctly for CDSCO submission.
• MDR Consultants can identify potential gaps in your application or compliance with MDR requirements.
• We can suggest strategies to mitigate risks and ensure your application meets all necessary criteria.
• We leverage our expertise and ensure transparency by providing regular status updates and conducting post-submission checks for clients

Communication and Liaison:

• MDR consultants can act as a bridge between you and the CDSCO, facilitating communication and addressing any questions or concerns that may arise during the application process.
• We can represent you in interactions with the CDSCO, ensuring your interests are effectively communicated.

Time and Cost Efficiency:

• By streamlining the process and avoiding potential delays, MDR consultants can help you obtain your MD-15 license faster.
• Their expertise can help you avoid unnecessary costs associated with application errors or rejections.

Additional Services:

We offer additional services such as: 

• Classification of your medical device according to CDSCO guidelines.
• Assistance with labelling and instructions for use requirements.
• Regulatory compliance training for your staff.