Daily use medical devices to see stricter checks | India News
New Delhi: Medical devices used every day – from syringes and surgical sutures to implants – may soon face stricter regulation, with the Center proposing stricter labeling rules and a standardized test fee system aimed at improving safety and accountability. Under a draft amendment to the Medical Devices Rules, 2017, manufacturers will have to clearly disclose on the product label where the devices have been sterilized, along with the facility’s license number. The move is intended to improve detection so that authorities can quickly identify the source in the event of an infection or device failure. The government has also proposed fixing examination charges across departments. According to the draft, implantation tests may cost Rs 5,000, infertility tests, Rs 2,000 and surgical stitches Rs 3,000. These charges will increase by 5% per annum, when determined by approved laboratories for non-listed tests 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. The industry, however, has raised concerns about feasibility and cost implications. Rajeev Nath, forum coordinator, Association of Indian Medical Device Industry, said that while the proposals are a step to strengthen quality systems, they may need to be fine-tuned for smooth implementation. “Test fees may not fully reflect actual lab costs, and if fixed without consulting NABL-accredited labs, it may make it difficult to sustain testing, leading to delays. This could increase compliance costs and put some pressure on supply and prices, especially for high-volume items like syringes and consumables,” he said. “A risk-based approach, with stricter checks for high-risk devices, would be more effective. The need for sterilization labeling also needs to be reviewed as it may delay exports by 3-4 weeks…,” added the forum coordinator.
