NEW DELHI: Medical devices commonly used—from syringes and surgical sutures to implants—may soon be subject to stricter regulations, as the government proposes updated labeling requirements and a standardized testing fee system aimed at enhancing safety and accountability.
Under a draft amendment to the Medical Devices Rules, 2017, manufacturers may be required to provide clear information on product labels regarding the location of sterilization, including the license number of the facility. This initiative aims to improve traceability, enabling authorities to quickly identify sources in the event of infection or device malfunction.
Additionally, the government has suggested setting fixed testing charges across various device categories. According to the proposal, implantation tests could be priced at Rs 5,000, sterility tests at Rs 2,000, and surgical sutures at Rs 3,000. These charges are expected to increase by 5% annually, while fees for any tests not listed will be determined by authorized laboratories.
Officials assert that these changes are designed to foster uniformity in testing processes and to strengthen oversight in the rapidly evolving medical devices sector, where regulatory inconsistencies have been a recurring concern.
However, industry representatives have expressed apprehensions regarding feasibility and financial implications. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, stated, “While the proposals are a step towards strengthening quality systems, they may need to be fine-tuned for smooth implementation. The testing fees may not fully reflect actual lab costs, and if set without consulting NABL-accredited labs, it could make testing difficult to sustain, leading to delays.
He further noted that this could increase compliance costs and exert pressure on supply and prices, particularly for high-volume items like syringes and consumables. Nath suggested that a risk-based approach—with stricter oversight for high-risk devices—might prove to be more effective. He also mentioned that the sterilization labeling requirement should be reconsidered, as it could delay exports by 3-4 weeks.
