The Union Health Ministry of India recently announced that the long waited Medical Device Act will be tabled in the winter session of the Parliament by the PMO (India). This expected notice was on the talks for a long time for this critical section (Medical Devices).

The main aim of the policy is to set up separate body (National Medical Device Authority) for regulating products manufacturing and sales in the country. The department of pharmaceuticals released a draft National Medical Device Policy in 2015 to give a proper guidance to the growth of this sector. The proposed Act is a step towards achieving this goal. In the past 20 years, the use of medical devices and diagnostics has grown considerably in India among all classes of people.

Doctors routinely prescribed these medical devices or implants for heart and kidney patients, urology and for different orthopedic conditions, hearing difficulties etc. Almost 70% of all the medical devices in terms of value are being imported from the United States and Europe countries for years as the domestic sector did not register the anticipated growth rate. The three key elements that determine the growth of any industry are quality, safety and fair pricing and that has to be the case with the medical devices also.

Ministry’s decision with a Materio-Vigilance Programme of India (MvPI) past year is intended to ensure medical devices safety in the country. The main aim of Materio-Vigilance Programme of India is to collect safety data in a systematic manner for regulatory decisions and actions on the use of medical devices by the health authorities.

Medical devices pricing is another area where some sort of a control needs to be introduced. At present huge margins are loaded on to the price of life saving products like drug eluting stents and other implants. The latest Act and rules have to address all these points so that interests of all stakeholders are taken into consideration. A detailed procedure for how to register your medical device in India and the current classifications of medical devices can be found in Morulaa blog section.