India to regulate medical implants to ensure their safety
The government on Friday decided to regulate the sale, manufacture and import of medical implants, a move that will ensure safe and tested medical devices reach the end-user. and help regulate the implant industry in India.
India Lack of scientific evidence on Indian implants, a major challenge: Dr Vijay Shetty
The growth of the implant industry in India has led to a lot of advancements in the medical sector in India, but along with these advancements come a lot of challenges like faulty implants, the regulation and tracking of implants can help prevent faulty implants.
Investigations into faulty hip implants highlight the urgent need for a law to regulate medical devices.
In 2017, the MoHFW issued the Medical Devices Rules. However, the country’s base legislation on implants continues to be the Drugs and Cosmetics Act, 1940, which does not have the scope to cover most modern devices, including hip implants. The Indian orthopaedic device market is valued at over 450 million dollars and is expected to grow by 30 per cent per year till 2025. The investigations into faulty hip implants bring out the urgent need for a law to regulate medical devices.
Government to monitor the price of orthopaedic knee implants
Government has decided to monitor the ceiling price of orthopaedic knee implants so that the price increase of implants do not increase beyond 10% in a given year.
Clinical trials may not be needed for medical devices approved, marketed in EU
The move seeks to remove regulatory bottlenecks, boost the availability of medical devices in India. The Union health ministry will soon issue a notification to this effect, formalizing the decision taken at this year’s June meeting
Research firm predicts growth of global 3D printed orthopaedic implants market
A recent market study by research firm FutureWise, predicts the global 3D printed orthopaedic implants market to register a Compound Annual Growth Rate (CAGR) of more than 5.9% during the forecast period from 2019 to 2026.