Medtech industry expects regulatory body to reclassify more medical devices

CDSCO to initiate workshops; industry says step will bring regulatory uniformity

Industry experts expect that the Central Drugs Standard Control Organisation (CDSCO) could reclassify more medical devices based on their risk approach under the Medical Device Rules (MDR), 2017.

 

This follows the apex regulatory body’s move to publish an updated list of classifications for 1,178 medical devices under four categories: interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices.

 

Terming the update a dynamic process, Rajiv Nath, forum coordinator of the Association of Medical Device Industry (AIMED), said that as more products and innovations are manufactured or imported into India, they will need to be evaluated for risk and then classified.

 

All medical devices in India are governed under the MDR, 2017, which classifies devices as high risk (Class C and D) and low risk (Class A and B).

 

Commenting on the step, Himanshu Baid, managing director of Poly Medicure, said that discussions have been ongoing between the medtech industry and the CDSCO to understand the need for reclassification and to strengthen the existing classification framework by introducing additional categories.

 

“The step will help ensure a more harmonised classification of medical devices, foster greater regulatory transparency, and enhance the safety and quality of healthcare products available to the public,” he added.

 

Sources indicated that the CDSCO will initiate a series of free workshops to identify and address gaps within the industry, fostering a collaborative approach to resolving them.

 

“To further align efforts and effectively address industry requirements, the CDSCO will organise a series of free workshops in collaboration with CII,” Baid said.

 

Rajiv Nath added that the risk-based reclassification would provide clarity and alignment for both regulators and manufacturers during the submission of licensing applications.

 

“This step is of strategic importance as the manufacturing licence for low-risk and high-risk devices is issued by state and central licensing authorities, respectively. In the absence of clarity, manufacturers faced challenges in preparing and planning for applications and compliance needs,” he added.

 

While the medical devices industry has welcomed the risk-based reclassification of medical devices by the CDSCO, it has urged the apex regulatory body to bring more clarity for regulatory compliance.

 

“We still find huge variances in the interpretation of Medical Device Rules between various state and central government regulators, as manufacturers wade through a daunting maze of lengthy regulatory approval hurdles,” Nath added.