The Central Drugs Standard Control Organisation (CDSCO) has made a significant amendment to the classification of medical devices in India. The new classification positions medical devices into four classes, based on their risk levels. The principle is to accord with international standards through alignment with the MDR 2017. The Drugs Controller General allowed comments to be made from stakeholders and industry groups within 30 days, as stated by Dr Rajeev Singh Raghuvanshi. 

Revised categories and new additions

The new classification has incorporated new headings in the categories of interventional radiology, radiotherapy, and oncology. A new Class A for non-sterile and non-measuring medical devices has also been developed. In the category of interventional radiology, 186 devices are now included. Other devices include those angiography-related which falls in Class C, cardiovascular MRI systems, and ultrasound, which falls under Class B. Other devices also include grids for MRI that are placed under Class A.

In radiotherapy, currently under 114 devices, important ones are tissue spacers made of absorbable and gamma knife for surgery, all of which come under Class D. Brachytherapy devices are included under Class C, and the list of oncology devices comes under 75, featuring accelerator system chair and cancer diagnostic probes under Class C while some electronic examination systems come under Class B.

Class A medical devices 

The list includes a significant number of 803 Class A medical devices, which are the least risky. In this category are reusable abdominal support belts, absorbent cotton wool, and many acupressure bands. These are merely classified under the category due to simplifying regulatory processes for lower-risk items while increasing safety standards.

Call for stakeholder engagement

Dr Raghuvanshi emphasized that stakeholder feedback was useful in finalizing these classifications. CDSCO has provided an application form to the associations, to submit their comments about the draft classification lists. The partnership will also try to seek the best balance for regulatory clarity with the desired level of localization of classifications on global best practices.

Overall, this new classification in the CDSCO for medical devices represents a stride toward an evolved and better organization of regulatory activity with more stress on patient protection, embracing advancing medical technology at the same time. All of these are inviting active participation and contributions from stakeholders toward forging a new, promising future in medical device regulation in India.