The report was released at the National Symposium of Safety of Medical Devices
India's medical device industry has a huge untapped potential and can be a major force globally, if proper regulatory frame work and support is provided, according to a report by the National Health Systems Resource Centre (NHSRC). The report was released at the National Symposium of Safety of Medical Devices, organised in association with UL (Underwriters Laboratories). It reinforces the need for bringing in a systematic and harmonised approach towards testing for safety and efficacy of medical devices.
The national symposium witnessed the launch of two reports on setting up medical device testing laboratories for electrical and electronic medical devices as well as for biomaterials and medical implants. The reports was developed by the National Health Systems Resource Centre, in technical collaboration with the WHO Country Office for India and with technical inputs from UL in India and Sree Chitra Tirunal Institute of Medical Sciences and Technology. It highlight the basic requirements, work flow, infrastructure and human resources required for establishing medical devices testing laboratories.
"The government approving 100 percent foreign direct investment (FDI) in the medical devices sector is a positive step towards developing the overall healthcare infrastructure, thereby reducing our dependency on imports. The expected inflow of investment should target research, testing and infrastructure strengthening to promote domestic manufacturing," said Mr Suresh Sugavanam, vice president and managing director, UL South Asia. He added, "UL has made significant investments in terms of resources and laboratories to support the industry. The current landscape is highly fragmented and calls for a restructuring of regulatory framework to boost the industry."
"Access to safe, good quality and effective medical devices is an important component of health services. With the increasing commitment of the government towards achieving health for the people, proportionate effort is required towards developing systems such as testing laboratories to support the medical devices sector. Only with comprehensive and collaborative effort can the nation progress towards self-dependency and bring cost-effective and safe medical technologies within the reach of masses," said Dr Sanjiv Kumar, executive director, NHSRC.