Stricter inspection of daily use medical devices

NEW DELHI: Medical devices used every day – from syringes and surgical sutures to implants – may soon face tighter regulations, with the Center proposing stricter labeling rules and a standardized test fee regime aimed at improving safety and accountability. Under the Draft Amendment to the Medical Device Rules 2017, manufacturers may be required to clearly disclose on the product label the location where the device was sterilized, including the facility’s license number. The move is aimed at improving traceability so authorities can quickly identify the source in the event of an infection or equipment failure. The government has also proposed fixing testing charges across categories. According to the draft, implantation test will cost Rs 5,000, sterility test will cost Rs 2,000 and surgical suturing will cost Rs 3,000. These fees will rise by 5% annually, while fees for unlisted tests will be determined by authorized laboratories. Officials said the changes are aimed at uniformizing testing and tightening oversight of the fast-growing medical device industry, which is often seen as unbalanced. However, industry has expressed concerns about feasibility and cost implications. Rajiv Nath, forum coordinator of the Indian Medical Device Industry Association, said that while the proposals are a step towards strengthening the quality system, fine-tuning may be required for smooth implementation. “Testing fees may not fully reflect actual laboratory costs, and if testing fees are determined without consultation with NABL accredited laboratories, it may make testing difficult to maintain, resulting in delays. This is likely to increase compliance costs and put some pressure on supply and prices, particularly for high-volume items such as syringes and consumables,” he said. “A risk-based approach, with more stringent inspection of high-risk equipment, would be more effective. Sterilization labeling requirements also need to be reviewed as it may delay exports by 3-4 weeks…” added the forum coordinator.