The Center proposes faster licensing to support the production of medical devices

The Union Health Ministry has proposed amendments to the Medical Devices Rules 2017 to simplify and speed up the licensing process for manufacturing medical devices while ensuring compliance with quality, safety and performance requirements, it said in a statement on Sunday..

“The initiative is aimed at ease of doing business, improving regulatory efficiency and facilitating timely availability of quality medical devices in the country. The government aims to reduce the statutory processing times for manufacturing licenses across various risk-based categories,” the statement said.

India’s $13 billion medical device sector, as estimated by the India Brand Equity Foundation (IBEF), is seeking regulatory reforms to reduce red tape and encourage domestic manufacturing.

Bureaucratic delays

Under existing rules, medical devices are classified into four risk-based categories – Class A, Class B, Class C and Class D – with Class D comprising the highest risk products.

The goal of the proposed changes is to shorten statutory waiting times for these categories and speed up regulatory approvals without jeopardizing established quality standards.

For Class B medical devices, which include low- to moderate-risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters, the manufacturing license period is proposed to be reduced from 140 days to 115 days.

For high-risk Class C and Class D medical devices, including critical life-saving technologies such as cardiac stents, hip and knee implants and other orthopedic implants, the timeline will be shortened from 105 days to 90 days.

The proposed changes introduce defined timelines for each stage of the licensing process, from initial review of applications and audits by notified bodies to verification of compliance and final issuance of production licenses.

According to the ministry, this granular approach is expected to bring greater transparency, predictability and efficiency to the domestic regulatory framework, ultimately benefiting both the medical device industry and patients through faster access to quality-assured medical devices.

The Center has published a draft notice for comments and suggestions from all stakeholders. The notification is available in the Official Gazette and on the website of the Central Drug Standards Control Organization (CDSCO). Stakeholders are invited to submit their comments and suggestions within 30 days.