Govt to introduce NEW definition of Medical Devices: Report
New Delhi: The government is going to adopt another definition of medical devices in order to include more medical equipment under its ambit, a recent media report has pointed out
With a new definition of the Medical Device which is likely to be notified by the Government shortly, all medical devices will mandatorily undergo an inspection by the Central Drugs Standard Control Organisation (CDSCO) prior to receiving market authorization. The Government is also working to bring a separate act to regulate medical devices, added the report in TOI.
The new definition will incorporate all such products, including diagnostic equipment, nebulisers, syringes as well as stents and other implants.
Earlier this year, in a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry had notified eight medical equipment, including all implantable devices, as “drugs” under Section 3 of the Drugs and Cosmetics Act.
Also Read: Eight medical devices including CT, MRI, X-ray notified as DRUGS by the health ministry
With the introduction of the new definition, all medical devices manufactured locally or imported will completely be regulated within 4 years, as the medical device makers will have to seek approval from CDSCO for manufacture, import and distribution of any medical device.
As per a recent media report in TOI, the firms will have to submit complete information of the product including design, shelf life and raw material along with evidence to establish the safety of their medical devices. Apart from this, the manufacturers will have to apprise about adverse events and carry out clinical trials for new products as per regulatory requirement.
The implementation of the regulation will commence with licensing, which will be voluntary for 18 months and become obligatory after 1 year and 2 years, depending on their classifying category based on risks.
Also Read: Manufacture of Class C, D medical devices: CDSCO makes Centre the licensing authority
Commenting on the same, an official source told TOI, "The idea is to have a roadmap for medical devices so that the 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."