CDSCO Releases Draft: 1,178 Medical Devices to be Reclassified into 4 Categories, AiMeD Welcomes Move
However, AiMeD urged regular meetings with stakeholders to clarify compliance and align Medical Device Rules interpretations across regulators.
New Delhi: The Centre is set to reclassify 1,178 medical devices into four key categories based on their risk levels, in line with the provisions of the Medical Device Rules (MDR), 2017. As part of this effort, the Central Drugs Standards Control Organization (CDSCO) has revised the existing list of medical devices and classified them into various categories.
The recently released draft list under the MDR, 2017, classifies a total of 1,178 medical devices into four main categories based on their intended use and associated risk levels. These categories include Interventional Radiology, which consists of 186 devices used for minimally invasive procedures like angiographic systems and catheters. The Radiotherapy category features 114 devices, including linear accelerators and brachytherapy systems used in cancer treatment. The Oncology category includes 75 devices such as biopsy instruments and tumor markers, specifically designed for cancer detection and treatment. Additionally, the Class A Non-Sterile and Non-Measuring Devices category lists 803 low-risk devices, including surgical instruments and diagnostic tools that are non-sterile and non-measuring.
Dr Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), stressed the importance of updating these classifications to address advancements in technology and to align with global standards. “The existing classification lists have been revisited, and new entries have been added based on their classification as per the relevant provisions of the MDR, 2017 and the internationally followed classification,” Dr. Raghuvanshi noted in a communication to stakeholders.
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.”
