Centre to reclassify medical devices to bring regulatory uniformity

New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under the Medical Device Rule, 2017.

As part of the plan, the Central Drugs Standards Control Organization (CDSCO) is revising the existing list of medical devices and classifying them into four categories—interventional radiology (186), radiology therapy (114), oncology (75) and a newly introduced category named class A non-sterile and non-measuring medical devices with 803 medical equipment.

This will ensure that a medical device will only be approved by a State Licensing Authority under the said category.

The medical devices sector in India is an essential for the healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions and disabilities.

Market size to grow

Currently, the market size of India’s medical devices sector is approximately $11 billion, which is expected to grow to $50 billion by 2030.

In India, all medical devices are regulated under the Medical Device Rule, 2017 and that the Central Licensing Authority needs to classify such medical devices as per risk-based approach.

“In this regard, the existing classification lists of the following categories have been revisited, and new entries have been added based on their classification as per the relevant provisions of the MDR, 2017 and the internationally followed classification,” said Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) in a communication to the industry stakeholders.

“We have updated the existing medical device list which belongs to these four categories as per their risk approach.  We have sought comments from the industry so that if there are any other medical devices which need to be added to the list they may share with us. The list may be finalized very soon,” said the official aware of the matter.

24 categories

There are 24 categories of medical devices for registration purpose such as Anesthesiology, Pain Management, Cardiovascular, Dental, Gastroenterological, Respiratory, Neurological etc.

“There is a huge technology advancement in the medical device sector. The updation of the list will give more clarity to the people and give harmaonised classification to the medical devices which is being approved in the country,”  said the official adding that in the near future more medical devices will be classifed under remaining categories considering their risk based approach.

Notably, the medical device industry is highly capital intensive with a long gestation period and requires development and induction of new technologies.

Despite recent experiences in accelerating domestic production of medical devices, most imports of medical devices are largely high-value and low-volume devices while the domestic production is largely low-value and high-volume diagnostic tools. At present, Indian depends on imports up to an extent of 86%.

Last year in November Mint reported that the government launched a scheme aimed at strengthening the medical devices industry with an initial outlay of ₹500 crore for three years 2024-2025 to 2026-27. The scheme targets critical areas of the medical device industry covering manufacturing of key components and accessories, skill development, clinical studies, development of common infrastructure, and industry promotion.

Queries sent to the health ministry spokesperson remained unanswered.