India’s medical device sector operates under stringent regulatory norms for the safety and security of medical devices. One of the aspects of this regulatory framework is the requirement for obtaining a specific license for various purposes. Among these, Form MD 14, regulated under the Medical Device Rules, 2017, plays a vital role.

Understanding Medical Devices (MD) and In-Vitro Diagnostics (IVD)

Medical Devices

Medical devices refer to instruments, apparatuses, implants, or software designed by manufacturers for specific medical purposes. These devices can be used for diagnosis, treatment, or monitoring of diseases and conditions in humans.

Examples–

• Patient Monitor
• Ventilator
• X-ray Machine
• BP Monitor

In-Vitro Diagnostics (IVD)

IVDs are medical devices and accessories used to test biological samples from body like blood, tissues and body fluids. This helps to detect diseases or monitor overall health. The term “In Vitro” means “In Glass” referring to tests conducted outside the body, often in lab settings.

Examples:

• Blood Glucose Monitoring Devices
• Alcohol Body Fluid Analyzer
• Urine Analyzer
• Cholesterol Analyzer

Form MD 14 In CDSCO

TO import the notified bodies medical devices for the manufacturer they must apply for the MD 14 license. This license is mandatory for the import of the medical devices in boundaries. MD 14 is an application for a license to import medical equipment of class A, B, C, or D. The license granted by the appointed indian agent must be appointed for the same. The agent will be ready to apply for the license of manufacturing (Medical Devices) and wholesale (Sale or Distribution) as per the medical device rules 2017. The agent will make the application and apply for the license that you required to enter the medical device industry.

What are the Eligibility Criteria for Import License?

Foreign manufacturers want to import medical equipment into India must obtain a Medical Device Import Registration Certificate, which requires the appointment of an authorized Indian agent. This representative must have a current Medical Device Wholesale License (for sale or distribution) or a wholesale license (for sale or distribution) by the CDSCO’s requirements. In addition, this chosen agent is responsible for commencing the application process for both approval and future renewal of medical device registration for import purposes within India.   

Easy Process of MD 14 Registration

All the importers of medical devices must understand the process of MD 14 Registration in India. This will help to regulate medical devices in India freely:-

Classification of Medical Device

The first step in importing a medical device is to determine if it requires registration under the Medical Device Rules of 2017 and whether it is classified as a regulated or unregulated item. In circumstances where registration is required, an assessment of the medical equipment must be performed using the risk-oriented categories indicated above.

Nomination of an Authorized Representative

A foreign producer cannot apply directly for a medical device import license. The regulations state that the manufacturer does not have the power to approach CDSCO for application submission directly. As a result, the manufacturer is required to work with an approved license agent, who might be either a business or an individual. In this case, the manufacturer must provide this agent power of attorney, allowing them to apply in the manufacturer’s name and contact the licensing body on the manufacturer’s behalf, submitting relevant data and papers.

Submission of Application using Form MD 14

Any medical device importer who wishes to register through the online portal must complete Form MD 14 and submit all required attachments. However, if the manufacturer/importer’s objective is to get the registration for training or research purposes, an application in form MD-16 must be filed, and the appropriate license certificate in form MD-17 will be provided. Before filing this application on behalf of the foreign manufacturer, the importer’s authorized agent must hold a Form 20 license for stock and sale, as well as a Form 21 B license for sale and distribution under the Medical Device Rules of 2017.

Grant of MD Import Registration in Form MD-15

After reviewing the application, if the authorizing authority believes that the applicant’s medical device is genuine and made by the pre-specified parameters, it may authorize registration and notify the applicant in the form MD-15. Any approval or rejection of the application will be communicated via the registered email address.

In a similar vein, if the objective is to import experimental medical devices for use in government hospitals or statutory medical institutes, the application should be in form MD-18. The necessary license will then be obtained using form MD-19. Furthermore, for the import of medical devices in restricted numbers designated for personal use, the right line of action is to file a Use form MD-20 to submit your application. Following this, permission will be issued using form MD-21.

Documents Required For Form MD 14 License

Here are the documents mentioned below:-

• Certificate of Incorporation/partnership deed
• A valid copy of the Medical Device wholesale license
• Power of attorney duly notarized
• Notarized copy of overseas manufacturing site or establishment or plant registration
• Animal studies Preclinical data
• Stability validation data, Clinical evidence
• Post Marketing Surveillance data
• Batch Release Certificates or Certificates of Analysis of finished product
• Biocompatibility validation data
• Medicinal substances data if the device contains Drug
• Biological Safety (TSE/BSE), Sterilization Validation data
• Label and IFU
• Device Design and Manufacturing process with flow chart
• Essential Principles Checklist
• Copy of the Device Master File
• Details of the Authorised Indian Agent
• ISO 13485 certificate for quality assurance
• Copy of latest inspection/audit report
• Reference to predicate or previous generations of the device
• Certificate of full quality assurance
• CE certification for designs
• Statement of Compliance
• Free sale certificate, duly apostille/notarized
• Regulatory approvals, if necessary 
• A copy of the Plant Master File

Role of ELT Regulatory Services

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