Manufacturing medical devices in India is about to become easier
What's the story
The Union Health Ministry has proposed changes to the Medical Devices Rules, 2017, with an aim to fast-track the process of granting manufacturing licenses for medical devices. The move is aimed at improving ease of doing business and ensuring timely access to quality products in India. The proposed amendments will reduce timelines across different risk categories of devices, from low-risk Class B to high-risk Class C and D.
Timeline cuts
Proposed amendments to cut down timelines for licensing
The proposed amendments would cut down the timelines for granting manufacturing licenses across different risk categories of medical devices. For example, the timeline for Class B devices would be reduced from 140 days to 115 days. Similarly, high-risk Class C and D devices would see a reduction in processing time from 105 days to 90 days.
Device classification
Medical devices classified into 4 risk-based categories
The Medical Devices Rules, 2017, classify medical devices into four risk-based categories: Class A, Class B, Class C, and Class D. Among these, Class D includes the highest-risk devices. The proposed amendments aim to simplify and expedite the licensing process while ensuring compliance with quality, safety, and performance requirements for each category of device.
Regulatory improvements
Draft amendments lay down specific timelines for licensing process
The draft amendments also lay down specific timelines for every stage of the licensing process. This includes application scrutiny, audit by notified bodies, compliance verification, and license issuance. The Health Ministry hopes these changes will bring more transparency, predictability, and efficiency to the regulatory framework. This would benefit both the medical device industry and patients by providing quicker access to quality-assured medical devices.
Public consultation
Stakeholders invited to provide feedback on draft notification
The draft notification for the proposed amendments has been published in the official gazette and is available on the Central Drugs Standard Control Organisation (CDSCO) website. All stakeholders are invited to share their comments and suggestions within a stipulated time period. This public consultation process is part of the government's effort to ensure transparency and inclusivity in policy-making processes.