The Center has proposed amendments to the Medical Devices Rules (MDR), 2017, aimed at expediting manufacturing licensing timelines for devices in different risk categories.
This will give a boost to India’s $15 billion medical device industry.
The Union Health Ministry on Sunday issued a draft notification proposing reduction in the statutory timelines prescribed by the Central Drugs Standard Control Organization (CDSCO) for processing applications for manufacturing licenses in three categories of medical devices.
Under the MDR 2017, medical devices are classified into four categories: classes A and B (low to moderate risk devices) and classes C and D (high risk devices).
The Center will now amend Rules 20 and 23 of the MDR, which govern the timelines for application scrutiny and auditing of medical device manufacturing sites with respect to Quality Management System (QMS) compliance.
As per the proposed amendments, the timeline for granting manufacturing license for Class B devices like blood pressure monitors, hypodermic needles and pulse oximeters is proposed to be reduced from 140 days to 115 days.
Similarly, the regulatory timeline for high-risk Class C and D devices, such as cardiac stents, hip and knee implants and other orthopedic implants, will be reduced from 105 days to 90 days.
However, no such timeline reduction has been announced for Class A devices.
Senior health ministry officials said the move to reduce the timelines is aimed at enabling faster regulatory approvals while maintaining established standards of quality, safety and performance.
“This will enhance ease of doing business, improve regulatory efficiency and ensure timely availability of quality medical equipment in the country,” an official told Business Standard.
Himanshu Baid, managing director of Delhi-based Poly Medicure, said the move will help boost domestic manufacturing as companies will be able to get licenses much faster.
According to the minutes of the meeting seen by Business Standard, the board had argued, “Specific timelines for conducting the audit and compliance verification of non-conformities reported in the previous inspection are not mentioned in the rule, resulting in delay in QMS inspection and compliance verification by the registered notified body in case of Class A and Class B medical devices.”
The ministry has invited objections and suggestions from stakeholders on the draft notification within 30 days before finalizing the amendments.