India Moves To Regulate The Sale Of Medical Devices To Better Monitor Quality

In the latest move by India’s regulatory authority to better control the safety of medical devices, the Ministry of Health and Family Welfare announced in February that all retail and wholesale outlets selling medical devices in India will be required to register with authorities of the states in which they operate.

The new registration requirement is designed to make it easier for government authorities to monitor the quality and source of medical device products of all kinds. Sales of medical devices are growing in India at a blistering pace, driven in part by the COVID-19 pandemic, which fueled demand for everything from thermometers to pulse oximeters, and exposed the lack of quality controls of such goods around the country.

Separately, the Ministry is making some tweaks to its standing requirement that importers of medical devices adhere to the International Organization for Standardization (ISO) quality standard 13485, recognized around the world as proof that a medical device adheres to specific requirements for quality, cleanliness, safety, and effectiveness. The changes make it possible for domestic manufacturers to gain approval for their devices for a limited period after they have applied for the ISO quality standard, but before they have obtained it.

The new requirements add more teeth to India’s nascent law of 2017, the first in the country to establish regulations on the medical device industry. Since then, authorities have sought to put in place a robust regulatory mechanism for device manufacturers, but have not focused on wholesale and retail sales of the devices. Previously, the medical device industry in India was largely unregulated, with only a small number of product families requiring registration by the government. These few device product families were treated as pharmaceuticals under the regulations.