Law Updates

Subject

Summary: The Government of India has introduced a new Risk Classification Module on the CDSCO Online System for Medical Devices. This update simplifies the approval process and makes it easier to classify medical devices that are not listed in the CDSCO published classification list. The module became active on 27 November 2025 under the Medical Device Rules, 2017. Any applicant can now submit device details through the CDSCO medical device portal to get the correct risk category for the product. This new system supports faster regulatory review, improves compliance, and helps ensure the safe use of medical devices across the country. The change also supports better transparency and smoother processing of applications for medical device risk classification.

Subject

Summary: The Central Drugs Standard Control Organization (CDSCO) has officially finalized the risk classification of medical devices used in interventional radiology and radiotherapy under the Medical Devices Rules, 2017. These classifications comply with the draft lists released on January 6, 2025. The updated lists are included in Appendix A of the respective notifications and give a structured framework for defining regulatory requirements for manufacturing and import. The CDSCO elucidates that the general intended use given for each device acts only as guidance, manufacturers may describe particular intended uses for their products. The notified classifications are active and may be revised from time to time under the Medical Devices Rules, 2017. Each device is assigned to Class A, B, C, or D, which determines the applicable regulatory pathway to ensure safety, quality, and compliance for technologies used in radiological and therapeutic procedures.

Subject

Summary: The Ministry of Health and Family Welfare on Tuesday notified draft amendment rules for the registration of Class A medical devices through an identified online portal established for the purpose. All the A and B-class manufacturers are required to transition to the licensing regime by 1st October. This notification came as a big relief to the manufacturers who are still awaiting audits from the government licensing authorities. The Key highlights of the draft amendment rules for Manufacturer The manufacturer has to only submit an undertaking stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring) The manufacturer shall self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices. The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.