• To import medical devices, the foreign manufacturer must appoint an authorized agent with a valid wholesale license to sell or distribute medical devices in India. The government of India has appointed CDSCO (Central Drug Standard Control department) to regulate the import of medical devices in india . Without permission and License from CDSCO, no foreign entity can sell its medical devices in the Indian market. There are different forms available that need to be filled to import medical devices with the help of authorized agents. For the past few years, CDSCO has made it mandatory to have an import license; thus, before any dealer or distributor decides to import medical devices, it is advisable for them to apply for the import license as per their requirements and needs.

The two major phases in CDSCO medical device import license are:

Phase 1 – Application Registration; Phase 2 – Import License Application 

Pre-requisites of a registration process are:

  • Brand name
  • Intended use
  • The material used in construction
  • Application mode
  1. Phase 1 - Application Registration:
  • The applicant can apply for the application on SUGAM, an online portal with the help of an authorized agent. The authorized agent must have a valid wholesale license per CDSCO guidelines to sell or distribute the medical device since AA will be the point of contact between the manufacturer and the CDSCO. 
  • The applicant can fill the form 14 or any other form as per the requirement mentioned below:

Form MD Name


Form MD-14

Application for issue of import license to import all classes medical device

Form MD-16

Application for License to import for purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

Form MD-18

License to import investigational medical devices for a government hospital or statutory medical institution for the treatment of patients

Form MD-20

Application for permission to import a small number of medical devices for personal use


  • Phase 2 – Import License Application:
  • After the applicant submits the documents, fees are paid by the applicant, and then it shows the change in application status. Other details, along with technical documents, need to be submitted given below:
  • Technical documents
  • Cover letter
  • Application form
  • Fees challan receipt
  • Applicant's details 
  • Information on product
  • Regulatory status
  • Device Master file
  • The device contains medicinal products (if applicable)
  • Post-market surveillance
  • After the document submission, the fees are paid, and the status of the application changes. Sometimes CDSCO raises the query if they found any gap. The manufacturer's responsibility, along with the authorized agent, should be able to provide the proper justification. And in case of a non-satisfactory answer, the CDSCO has the right to reject the application.


  • License validity – The MD 15 shall remain valid in perpetuity, unless, it is suspended or canceled, provided the registration holder deposits a registration retention fee to the Central Licensing Authority


Steps to get an import license:

Conclusion –As per the CDSCO guidelines, class A and B Non notified medical devices need an import license before 1st Oct 2022, whereas class C and D Non notified medical devices have a timeline till 1st 2023. CDSCO has started to make regulations stricter day by day to get the best quality of medical devices. With the increase in household incomes, people have begun to pay more attention to their health, leading to increased demands. Medical devices not only help in diagnosis but also helps in the treatment and assist doctors in determining the course of treatments, cure, and disease prevention. Thus, demands for these devices are now at an all-time high. CDSCO is making amendments to its regulations to import only those devices which are safe, efficient, have good quality, and have a high benefit-risk ratio.