Introduction

On February 11, 2020, the Ministry of Health and Family Affairs (MoHFW) issued a notification classifying all medical devices under section 3(b) (iv) of the Drugs and Cosmetics Act, 1940 from April 1, 2022

To ensure regulations of medical devices, the Ministry of Health and Family, (MoHFW) launched G.S.R 102(E), on 11 February 2020, outlining a phased approach to regulating these devices. As per this notice, Class C and Class D medical devices will be subject to the licensing system from October 1, 2023

On April 12, 2022, the Central Drugs Standard Control Organization (CDSCO) issued a circular stating that Class C and Class D medical devices, which are currently subject to compulsory registration, will come under the licensing regime from October 1, 2023

Read Our Blog: Procedure for Manufacturing of Class C and Class D Medical Devices In India

In India, medical devices are primarily regulated by the Drugs and Cosmetics Act, 1940(DCA) and the Medical Devices Regulations (MDR), 2017

Classes C and D are classified by risk as Class C- Moderately High Risk and Class D- High Risk. Therefore, as per Rule 8 of the MDR, only the Central Licensing Authority, which is the Drug Controller of India, is competent to deal with matters related to the manufacture of devices i.e. Class C and Class D

Central Drug Standard Control Organization (CDSCO) advises manufacturers and importers to apply for manufacturing/import licenses through their authorities by Online portal and required documents and fees under (Medical Devices Rules (MDR) 2017. Applications are proactively processed for authorization within a specified timeframe to avoid disrupting medical device supply chains and patient access. That applications shall be considered valid and the importer/manufacturer may continue to import/manufacture the said equipment for a maximum period of six months from the date of issue of this order or until the decision of the Central Licensing Authority, whichever is earlier.

Devices not listed in the notified device list are not regulated in India. The CDSCO portal should contain a list of these devices. IAAS (Indian Authorized Representatives) are required by foreign companies wishing to sell these devices in India. It is important to note that Medical Device Officers (MDO) of the Central Licensing Authority (CLA) require inspection of medical devices. Rules (MDR 2017 must be formalized within 60 days (approximately two months) from the date of application to ensure compliance with the Fifth Schedule of MDR 2017. Prompt action will ensure a smooth transition to the new licensing system by October 1, 2023. 

To ensure that supplies of medical devices in India are not disrupted, CDSCO will process applications for proactive manufacturing/ import licenses to be issued by the deadline (earlier) i.e. 1 October 2023

In summary, manufacturers and importers who submitted a Class C and D medical device license application to CDSCO on or before 09/03/2023 may continue to manufacture and import Class C and D medical devices for six months until they obtain a CDSCO license. In addition, importers of Class C and Class D medical devices may be required to notify the Customs Officer of the Status of their application with Circular no 29 to prove their eligibility for import of Class C and Class D medical devices in India and shipment classification.

However, manufacturers and importers who have not applied for a license by September 30, 2023, cannot engage in business related to medical Class C and Class D appliances.

The medical device market in India is rapidly growing and is characterized mainly by the private sector's demand for high technological quality standards. For these reasons, CDSCO raises the bar on device marketing to ensure the sale of safe and effective products and protect patient health.