India’s health ministry has recently approved a program to systematically monitor medical device adverse events. Previously, India relied on adverse events reporting from developed countries such as the U.S. The medical device market in India is valued at $3.5 billion and more than 75% of the country’s devices are imported.
The Central Drugs Standard Control Organization (CDSCO) will work with the Sree Chitra Thirunal Institute for Medical Sciences and Technology to track and compile device safety records and adverse events reports. The National Health Systems Resource Center’s Division of Healthcare Technology will provide technical support. Furthermore, the program will also increase awareness among doctors and other health professionals about the importance of reporting on medical device adverse events.
After development and testing, the Materio Vigilance Program of India will be implemented nationwide, involving private hospitals, medical colleges and district hospitals. Based on the data, the government could implement regulatory changes as well as require changes to specific medical devices, including labeling alterations, product recalls or product bans.
For product re-registration, many applicants are being asked by the CDSCO for adverse event information. Thus, companies will need to keep close track of these incidents.