Medical device makers fear closure as new norms kick in

Notification mandates inspection of all Indian manufacturing units by drug controlling authorities

The central government announced the final medical devices regulations on Thursday. The rules state the shelf life of medical devices should be five years. The notification classifies medical devices into four categories — low risk, low-moderate risk, moderate-high risk and high risk devices. While the entire medical devices industry welcomes separate rules for medical devices, they are not quite happy with the fine points mentioned in the notification. 

Rajiv Nath from the Association of Indian Medical Device Industry (AiMeD) says, “The proposed regulations may result in closure of domestic manufacturing and drive jobs out of India as more manufacturing of high-risk