Import license for medical device in India

In India, nearly 80% of medical devices are imported with enormous market size of USD 6 Billion. It is significant for an overseas manufacturer to comply with Indian Regulations to ascertain safety, quality and efficacy of the medical devices as per Medical Device Rules, 2017. An overseas manufacturer has to assign an Authorised agent in India through power of attorney for the import of medical devices in India as specified in 3(f) of Chapter I. As per section 34 (1) of Chapter V, the Authorised agent with valid wholesale license (20 B & 21 B/21 C) or manufacturing license has to apply online through Form MD-14 and the approved Import License will be issued in Form MD-15. It is vital to explore with predicate device details such as Device Design, intended use, material of construction, shelf life, etc., for the applied device in Indian market approved by CDSCO based on Drugs and Cosmetics Act & Medical Device Rules, 2017 effective from 01.01.2018. The checklist for the application is accessible in the website ( https://cdscomdonline.gov.in/ ) indicating the notarized/apostilled documents for license application appropriately. The essential documents required for import license are specified in the Fourth Schedule. The Part I of the Fourth Schedule, stipulates the format for the Power of Attorney of import license along with undertaking from the Authorised Indian agent. The content requirements of the plant master file and device master file are specified in Appendix I and II of Part III in Fourth Schedule. However, Class A devices required less documentation and fees compared to other risk class devices as specified in Part II (i) of Fourth and Second Schedule respectively.

The fees payable for the import licenses of medical devices vary based on their Risk Class. As per 34 (2) of the Second Schedule, for Class A device the payable fees is 1000 USD for the manufacturing site and 50 USD for each distinct medical device, while, for Class B device the payable fees is 2000 USD for the manufacturing site and 1000 USD for each distinct medical device. However, Class C and Class D devices the payable fees is 3000 USD for the manufacturing site and 1500 USD for each distinct medical device. Further, Chapter V 34 (4) rule specifies any subsequent (endorsement) application for additional medical devices for the same manufacturing site needs to pay additional fees for each medical devices based on their Risk Class. Similarly, an additional manufacturing site for the already licensed medical device needs to pay additional fees as per 34 (2) of the Second Schedule. The license granted is perpetual in nature and retention fees must be paid for the licensed manufacturing site as well as medical devices on completion of every five years.

At present, only limited medical devices/equipments are regulated under the notified category in India as mentioned in table 1 and various medical devices under these notified devices are regulated with their Risk Class and Intended use. Earlier, an Office Memorandum dated 15.11.2019, the products approved as a medical device in country of origin but not covered under notified device in Medical Device Rules, 2017 and fall under the definition of Drug/New Drugs will be regulated as Drugs with regulatory documents of the medical device to streamline and ease the application process. In the forthcoming year, notified medical devices/equipments will be regulated as dates listed in table 2 and the registration process for the regulation of all the non-notified medical devices is effective from 01.04.2020.

Table 1

Table 2