India to Intensify Audits for Medical Device Manufacturers
India plans to increase audits of medical device facilities, with a test-license waiver under discussion, says DCGI.
India's regulatory authority for pharmaceuticals and medical devices is set to enhance its scrutiny of the medical device sector. Dr. Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), announced at the Confederation of Indian Industry's (CII) 18th Global MedTech Summit that the country will ramp up audits of medical device manufacturing facilities to ensure compliance with regulatory standards.
Increased Oversight and Industry Adaptation
Over the past two years, the DCGI has issued 30,000 product licenses, focusing on facilitating approvals. However, moving forward, Dr. Raghuvanshi emphasized a shift towards more stringent audits, stating that the industry has had ample time to adjust to the regulatory framework. Discussions with stakeholders have highlighted the need for manufacturers to be prepared for these inspections.
The Indian medical device industry, valued at approximately $16 billion, comprises around 800 manufacturing units, primarily producing low-risk devices. The sector is projected to expand to $50 billion within five years, propelled by the National Medical Devices Policy, 2023.
Streamlining Approvals and Deregulation Efforts
Efforts to streamline the regulatory process have led to a reduction in the timeline for processing import applications to about 145 days, down from the previous nine-month standard. From April 2025 to June 2026, 1,082 import licenses were granted, with similar improvements seen in the processing times for in-vitro diagnostics (IVDs) and high-risk medical devices.
In a move towards deregulation, the DCGI is considering removing the requirement for a test license for devices under trial, akin to existing provisions for drug manufacturers. This proposal will be discussed at the upcoming Drugs Technical Advisory Board (DTAB) meeting. This initiative aims to foster innovation by easing the research and development phase for new medical devices.
Structural Changes and Workforce Expansion
Amidst calls for a dedicated regulatory body for medical devices, a new joint DCGI-level position has been created to provide greater autonomy to the medical device division within the Central Drugs Standard Control Organization (CDSCO). The agency is also expanding its workforce, recently promoting 21 drug inspectors to Assistant Drugs Controller and recruiting 20 additional medical device officers.
Rajiv Nath, Forum Coordinator for the Association of Indian Medical Device Industry (AiMeD), expressed support for delegating audit responsibilities to NABCB-accredited certification bodies for high-risk devices, aligning with global practices.