CDSCO Releases Draft: 1,178 Medical Devices to be Reclassified into 4 Categories, AiMeD Welcomes Move

The revised classification incorporates new devices based on their risk levels under the MDR, 2017, and aligns them with internationally recognized standards. This step ensures the implementation of risk-based regulatory measures, offering clearer guidelines for the approval and usage of medical devices. To gather further insights, the government has invited stakeholders to submit feedback on the updated list within 30 days via an online form.

Speaking to Medical Dialogues, Rajiv Nath, Forum Coordinator, AiMeD explained, “The detailed Risk-based classification and expansion of the earlier list of medical devices into various categories of low-risk Class A, Moderate Risk Class B, Moderate High Risk Class C & High Risk Class D is very welcome as it provides clarity and alignment to Regulators and Manufacturers for submission of Licensing applications. This becomes of strategic importance as manufacturing licenses are issued for low-risk devices by State Licensing Authorities and for high-risk devices by the Central Licensing Authority, and in the absence of clarity, manufacturers were challenged to prepare and plan for applications and compliance needs.”

“While welcoming this progressive step, we urge constant webinars and conferences and meetings with stakeholders to bring clarity for regulatory compliance needs and alignment as we find huge variances of interpretation of Medical Device Rules between various state and Central Government regulators. Manufacturers wade through a daunting maze of lengthy regulatory approval hurdles so that regulatory approvals can be expedited without compromising on patient safety concerns to enable faster market access. India is highly important and at this stage, we seek the role of the Regulator as facilitator and educator," Nath added.

“Manufacturers will now be able to initiate the Licensing process for these products. The license application has to be filled online, and if the product classification is not known, the application can’t be filled, and the process stalls. There will be delays until one reaches out to CDSCO and recommends the classification they feel is appropriate based on other jurisdictions like the EU or Singapore, etc., as a precedent," he further expressed.

“As more products and innovations are manufactured/imported into India, these will need to be evaluated for risk and then classified. Based on case-by-case experience, the list may get updated periodically as it’s a dynamic process.”