Daijiworld Media Network - New Delhi

New Delhi, Jun 28: The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, aimed at significantly reducing the time required for granting manufacturing licences for medical devices, in a move intended to improve ease of doing business while ensuring quicker availability of quality medical products in India.

The ministry has issued a draft notification in the Official Gazette inviting comments from stakeholders on the proposed amendments, which seek to simplify regulatory procedures without compromising the existing standards of quality, safety and performance applicable to medical devices.

Under the current regulatory framework, medical devices are categorised into four risk-based classes—Class A, Class B, Class C and Class D—with Class D covering devices that pose the highest level of risk.

One of the key proposals is to shorten the approval timeline for manufacturing licences across different categories of medical devices. For Class B devices, which include low- to moderate-risk products such as blood pressure monitors, pulse oximeters and hypodermic needles, the licensing period is proposed to be reduced from 140 days to 115 days.

The ministry has also proposed cutting the approval period for Class C and Class D devices from 105 days to 90 days. These categories include high-risk medical products such as cardiac stents, hip and knee implants, and other critical orthopaedic devices.

In addition to reducing overall approval timelines, the draft amendments introduce clearly defined deadlines for every stage of the licensing process. These include scrutiny of applications, inspections and audits by notified bodies, verification of compliance with regulatory requirements, and the final issuance of manufacturing licences.

According to the ministry, establishing fixed timelines at each stage of the approval process will improve transparency, enhance predictability for manufacturers and make the regulatory framework more efficient.

The proposed reforms are aimed at strengthening India's medical devices ecosystem by facilitating faster regulatory clearances while maintaining rigorous standards for product quality, safety and performance. The ministry said the changes are expected to benefit both manufacturers and healthcare providers by enabling quicker access to reliable and quality-assured medical devices for patients.

The draft notification has been placed in the public domain through the Official Gazette and is also available on the website of the Central Drugs Standard Control Organisation (CDSCO). The ministry has invited industry representatives and other stakeholders to submit their comments and suggestions within the prescribed consultation period before the amendments are finalised.