An Overview of Medical Device Import License

If any manufacturer is planning to import medical devices in India for the purposes of their distributions, sale etc. in the Indian market, then he needs to obtain medical device import license. The manufacturers are required to fulfill all the standards of quality and efficacy to import the medical devices in India. The Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017 are applicable for the distribution, sale, manufacture and import of medical devices into India.

Which regulatory body is responsible for issuing Medical Device Import License in India?

The Central Drugs Standard Control Organisation (CDSCO), established under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, is the National Regulatory Authority and the Central Licensing Authority for importing all the medical devices across all classes from A to D in India. 

Who is eligible to apply for Medical Device Import License in India?

An authorised agent is eligible to make an application for obtaining the Medical Device Import License in India. The agent must have a license to manufacture (for sale or distribution) or hold a wholesale license in Form 20B and Form 21B (sale or distribution) as per the guidelines issued by CDSCO. An authorised agent can be an individual or a firm. 

Risk-based Classification of Medical Devices in India

According to the latest amendments, medical devices in India have been classified on the basis of the following four categories based on their usage risk:

Forms required for CDSCO Medical Device Import License

The Central Drugs Standard Control Organisation has prescribed the following forms for the importers to obtain a medical device import license. These forms differ on a case-to-case basis. Following are the various divisions of CDSCO:

For Existing Devices 

For an importer who wishes to obtain a medical device import license for the existing goods, CDSCO has prescribed the following two forms:

• Application form: MD-14
• Permission form: MD-15

It must be noted that these forms are meant for all the risk categories right from A to D.  

New Devices

Where an importer wishes to obtain a medical device import license for new medical devices which do not have predicate medical devices, CDSCO has prescribed the following two forms:

• Application form: MD-26
• Permission form: MD-27

Again, these forms have been meant for all the medical devices falling in the above-mentioned categories. 

Procedure for obtaining Medical Device Import License

Following is the simple 4 step procedure to obtain Medical Device Import License:

Step 1: Classification of the Medical Device

The first step in importing a medical device is to check whether it requires registration under the Medical Device Rules, 2017 and to see whether it is a regulated or non-regulated product. If the medical device does require registration, then evaluation of the medical device must be done on the basis of the above-mentioned risk-based categories.

Step 2: Appointment of an Authorised Agent

For obtaining a medical device import license, an overseas manufacturer cannot submit an application directly. The regulations prevent the manufacturer from directly making an application to CDSCO. Such a manufacturer requires the help and support of an authorised licensing agent, which may be a firm or an individual. The manufacturer needs to give that agent power of attorney to file the application on behalf of the manufacturer and liaise and present data and necessary papers with the licensing authority on behalf of the manufacturer.

Step 3: Filing of Application in Form MD-14

The central licensing authority, i.e. CDSCO, requires the applicant to make an application in the form MD-14. The applicant, i.e. the authorised agent, must have a license for stock and sale in Form 20 and 21 B for sale and distribution under Medical Device Rules, 2017 before making the said application on behalf of the overseas manufacturer. 

Step 4: Obtain Import License in Form MD-15

CDSCO is the central regulatory body that is responsible for giving approvals to the applications for importing medical devices into India. The import license in Form MD-15 is procured from the CDSCO as per the Medical Devices Rules, 2017.

Note: Where an importer or a manufacturer wants to import medical devices for the purposes of training or demonstration purposes, or clinical investigations, an application for the same must be made in form MD-16, and a license for the same can be procured from CDSCO under form MD-17.

Similarly, application for the import of investigational medical devices for the government hospitals or statutory medical institutions for the treatment of patients, application in form MD-18 will be made, and license will be procured in form MD-19.

Further, for importing medical devices in small quantities for personal use, an application shall be made in form MD-20 and permission shall be granted under form MD-21.

Approval of CDSCO Medical Device License

If CDSCO approves your application, an email of approval is sent to your registered email id. The license is obtained when the applicant receives the email of approval in Form MD-15. In case the application is rejected, a rejection mail to that effect will be sent to the applicant’s email id.