What is Form MD 14 in CDSCO?

Form MD 14

Form MD 14 is known as the CDSCO application form for importing medical equipment into India. When a foreign producer wants to export medical devices to India, the application must go via an approved Indian agent or distributor. This representative must have a valid wholesale license (MD 42) for the selling of medical devices in India.

Form MD 14 In CDSCO

Form MD 14: This is an application for a license to import medical equipment of class A, B, C, or D. 

Form MD 15: This is a license form granted by CDSCO that allows anyone to introduce medical equipment into India based on categorization A, B, C, or D.

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 device 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:-

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

Role of ELT Regulatory Services

ELT Regulatory Services is one of the leading companies in the world of legal. Anyone can take free business consultation with a few easy steps. Professionals here are well-experienced in the field and always ready to help. To take any advice from ELT regulatory services simply call on the no. mentioned above on the page.

FAQ (Frequently Asked Questions)

What is the medical device import license?

The medical device import license is a regulatory authorization provided by the Central Drugs Standard Control Organization (CDSCO) to permit the importation of medical devices into India.

Can I import medical devices without a license?

You can only import Medical Devices into India with a proper Importer License.

Are there any specific regulations or guidelines to comply with for importing medical devices into India?

Yes, Medical Device Importers in India must follow all the Medical Device Rules. Covering aspects are labeling requirements, device qualification, post-market surveillance, and quality management systems.

How do I apply for a medical device import license in India?

To apply for a Medical Device Import Licence in India, one has to submit all the important documents on the online CDSCO online portal.

Can there be multiple importers for the same product?

Yes, there can be Multiple Importers for similar products, but keep this in mind to fulfill all the requirements.

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