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New Delhi: Medical devices used every day, from syringes and surgical sutures to implants, may soon face strict regulation, with the Center proposing strict labeling rules and a standardized testing fee system aimed at improving safety and accountability. Under the draft amendments to the Medical Devices Rules, 2017, manufacturers may be required to clearly disclose on the product label, including the license number of the facility where the devices have been sterilized. The move aims to improve traceability so that authorities can quickly identify the source in case of infection or device failure. The government has also proposed to fix testing fees across all categories. According to the draft, implantation test may cost Rs 5,000, sterility test may cost Rs 2,000 and surgical stitches may cost Rs 3,000. These charges will increase by 5% annually, while fees for tests not listed will be decided by authorized laboratories. Officials say the changes are aimed at bringing uniformity to testing and strengthening oversight in the fast-growing medical device sector, where regulation has often been characterized as uneven. However, the industry has raised concerns over feasibility and cost implications. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, said the proposals are a step towards strengthening quality systems, but they may need to be fine-tuned for smooth implementation. “Testing fees may not fully reflect actual laboratory costs, and if decided without consulting NABL-accredited laboratories, testing may become difficult to maintain, leading to delays. This may increase compliance costs and put some pressure on supplies and prices, especially for high-volume items like syringes and consumables.” He said, ”A risk-based approach with strict scrutiny would be more effective for high-risk devices. The sterilization labeling requirement also needs to be reviewed as it may delay exports by 3-4 weeks, the forum coordinator said.