A new draft for medical devices Stents and orthopaedic implants may come soon under stringent regulatory, proposing stricter norms for firms selling such medical devices to confirm quality.

This draft proposes a shelf life for all medical devices and also makes it mandatory for products to contain manufacturing and expiry dates. It also suggests that firms must get approval for their products from the regulator before launching them in the market. Through a gazette notification the ministry released the draft rules and the government has got comments from all stakeholders within a month after which the rules will be finalized.

The action comes in the track of increasing use of critical medical devices like stents, catheters and implants. The main feature of draft rules are mainly the need for the government regulating the medical devices sector due to the inherent risk. The rules also have exact definitions and classifications. For instance, it has categorized medical devices into 4 different classifications based on risk estimation. The ones with higher risk such as stents and implants may also require clinical trials to get approval.

In India almost $7 billion medical devices is clubbed with medicines and is regulated under the same standards. Up to now the industry has maintained the absence of a separate law and regulator poses a major challenge for the industry’s growth. Rajiv Nath of Association of Indian Medical Devices Industry, an association representing domestic manufacturers said, the latest draft regulations are an assault on `Make in India‘ program.

Multinational companies have also upraised concerns over the proposed rules saying internationally regulators allow at least ten years of shelf life and the suggested standards may push up prices of imported products as companies will have to customize packaging accordingly.