New definition of med devices to include nebulisers, syringes

NEW DELHI: The health ministry is set to notify a new definition of medical devices which will expand the span of regulation to cover all such products, including diagnostic equipment, nebulisers, syringes as well as stents and other implants.


The notification, already approved by the ministry, is expected to be notified by the end of this week, official sources told TOI.

"The new definition for medical devices will be aligned with that of the International Medical Device Regulators Forum (IMDRF) and one which is globally accepted," an official said.

Once the new definition is notified, all medical devices will fall under the health ministry's regulatory purview and will have to undergo scrutiny by the Central Drugs Standard Control Organisation (CDSCO) before entering the market.

This means companies will have to seek approval from CDSCO for manufacture, import and distribution of any medical device. Besides, they will also have to report adverse events and carry out clinical trials for new products as per regulatory requirement. All medical devices manufactured or sold in the country will also be monitored for quality, safety and efficacy.

At present, only 35 medical devices are notified as drugs in India, of which 23 are regulated and the rest will come under regulatory purview from next year, according to the ministry's earlier notification.

The regulator has also prepared a roadmap for regulating these products after consultations with various international regulators under IMDRF and inter-ministerial consultation.

"The idea is to have a roadmap for medical devices so that manufacturing of products can be promoted in the country. Approval, certification and registration from a central authority under the health ministry will help in strengthening the credibility of 'Made in India' medical devices," the official said.

The government is also working to bring a separate law to regulate medical devices.

Besides, it is mulling an overarching pricing policy to cap trade margins of all medical devices.

The medical devices industry, currently pegged at around $7 billion in India, is growing at a CAGR of 4.5%. The sector is projected to touch $9.6 billion by 2022.

The implementation of regulation will start with licensing, which will be voluntary for 18 months and become mandatory after 12 and 24 months, depending on their classifying category based on risks.

Companies will be required to give details of products including design, shelf life and raw material along with other proof of evidence that their products are safe and efficacious.

According to sources, all medical devices in the country - whether manufactured locally or imported - will be completely under the regulatory framework within three-four years.

Medical device manufacturers, lobbying for a separate regulation for their products distinct fom drugs, say all devices must be regulated to create a level-playing field and ensure patient safety.