New Delhi: India plans to exempt low-risk medical devices from cumbersome licensing processes and replace it with a system of self-certified online registration, according to two government officials and documents reviewed by Mint.
As part of a plan to ease approvals and support the government’s push for indigenous manufacture of medical devices, sector regulator Drugs Controller General of India (DCGI) has finalized a list of 1,065 low-risk medical devices such as acoustic stethoscopes, wheelchairs, and alcohol swabs that will be exempt from licensing requirements.
The new system mandates that manufacturers and importers obtain a registration number on the Central Drugs Standard Control Organisation (CDSCO)’s online system and self certify the device’s safety. Besides pharmaceuticals, CDSCO is responsible for the safety and quality of medical devices, cosmetics, and diagnostic kits in India.
This mandatory registration will ensure regulatory oversight by providing the regulator a complete database of all low-risk devices in the country.
The new approach aligns with global regulatory standards, including those in the European Union and the United States, where low-risk products benefit from a simplified conformity assessment.
The market size of India’s medical devices sector is currently $11 billion, accounting for 1.5% of the global market, according to government’s ‘Invest India’ portal that facilitates business investments in the country. This is expected to grow to $50 billion by 2030
Inherently low risk
The DCGI’s final classification defines these 1,065 products as Class A (non-sterile and non-measuring), acknowledging that they pose the least risk to patients.
This list covers a vast range of essential items, including basic surgical tools like abdominal scissors and bandage scissors, along with general support devices such as abdominal support/belt/binders and air cushion or pressure relief cushions.
The exemption, made under the Medical Devices Rules, 2017, explicitly means these devices are relieved from following several stringent requirements, including those for manufacturing and import licensing.
A senior official familiar with the matter said that this shift is focused on economic and operational efficiency.
“By moving this large volume of essential products to a registration-only system, the CDSCO aims to significantly accelerate market entry and development, which is absolutely critical for strengthening the domestic manufacturing ecosystem,” the official said.
Dr Harsh Mahajan, founder and managing director of New Delhi-based Mahajan Imaging & Labs, called the change in rules a “timely enabler for India’s diagnostic ecosystem.”
For instance, his company uses a range range of low-risk devices from sterile swabs and collection vials to thermometers. “Simplifying the regulatory hurdle for such devices will help streamline procurement, reduce reliance on imports, and significantly improve supply chain resilience, ultimately ensuring seamless patient care,” he said.
Rigorous follow-ups
Dr Mahajan, however, cautioned for the need of continuous vigilance. “The proposed self-certification model must be supported by rigorous post-market surveillance and unique device identification to uphold quality and patient safety.”
Before the Medical Devices Rules, 2017, many of these items were often forced into the rigid regulatory framework of the Drugs and Cosmetics Act, 1940, which applied complex procedures primarily designed for pharmaceuticals.
A medical device industry representative said the move would help both the licensing authorities and companies in the sector and usher in “risk proportionate regulatory compliance”.
“The industry had sought parity with regulations in Canada, USA etc. to have minimal regulatory requirements for such low risk devices differently from sterile devices for ease of doing business which the ministry of health and family welfare has agreed (to),” said Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry or AIMED.
Queries sent to the health ministry spokesperson remained unanswered till press time.
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