In a bid to make the medical device industry competitive at the global level and ensure safety of the consumers, the Union Health Ministry has made it mandatory for the companies manufacturing such products to follow quality as well as good management system. The revised draft of the Medical Devices Rules 2016 was released recently.
Though presently there are just 15 medical devices which are notified, once the rules are enforced a large number of medical gadgets are likely to come under the legal purview.
Sources in the Union Health Ministry said that ) in the revised draft of the Billl, the Drug Controller General of India (DCGI has categorized the devices in four list, depending on their usage and threat to the life.
low and low-moderate risk devices, which include non-invasive devices used for compression, would be listed as class 'A' and 'B' devices, while moderate-high and high-risk devices, which include devices required to be inserted in the patient for long-term use, would be categorised as class 'C' and 'D'.
According to the sources, the DCGI will be the Central licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to import, manufacture of Class C and Class D medical devices, clinical investigation and clinical performance evaluation of medical devices and other related functions.
To ensure safety, 'Quality Management System' and 'Good Manufacturing Practices' (GMP) have been made mandatory for notified medical devices.
Some of the provisions include educational qualifications of workers involved in making the devices, third-party quality consultants for manufacturing site audits, and surprise inspections of these sites to uphold quality standards. Importantly, the rules also define and regulate medical devices separately from drugs and cosmetics.
As the Government pushes for Make in India campaign, high hopes are being made from the medical devices sector. Industry sources say that the sector has a tremendous potential to grow with a huge demographic dividend on demand side and India's research and development innovation capabilities on the supply side.
If this happens then, medical device sector can dominate the global market as is being done presently by the Indian pharma industry manufacturing drugs.