Centre proposes faster licensing to boost medical device manufacturing

Centre proposes faster licensing to boost medical device manufacturing

Theindiapostdaily.com – India’s Union health ministry has unveiled proposed changes to the Medical Devices Rules, 2017, aiming to streamline and accelerate the licensing process for medical device production. The reforms are designed to uphold standards for quality, safety, and performance while reducing bureaucratic bottlenecks, as outlined in a statement released on Sunday.

“This move seeks to enhance business efficiency by streamlining regulatory procedures and ensuring quicker access to essential medical equipment,” the ministry stated. The goal is to shorten statutory processing times for manufacturing licenses across different risk categories without sacrificing quality controls.

Industry’s Call for Reform

India’s medical device sector, valued at $13 billion according to the India Brand Equity Foundation (IBEF), has long advocated for regulatory changes to cut delays and encourage local production. The new proposals address these concerns by introducing structured timelines for approval processes.

Classification and Timeline Adjustments

Medical devices are currently divided into four risk tiers—Class A, B, C, and D—under the existing framework. Class D devices, which include high-risk items like cardiac stents and orthopaedic implants, face the longest approval periods. The draft amendments propose reducing the licensing duration for Class B devices from 140 to 115 days and for Classes C and D from 105 to 90 days.

The revised rules define specific timeframes for each phase of the licensing cycle, from application review and audits by recognized bodies to final compliance checks. This methodical approach is intended to improve transparency and predictability in the regulatory system, according to the ministry.

Public Consultation and Implementation

The draft notification has been published for public feedback, inviting input from stakeholders through the Official Gazette and the Central Drugs Standard Control Organisation (CDSCO) website. Comments are due within 30 days, ensuring broader participation in shaping the new framework.