Indian medical device manufacturers have cautioned that the recently introduced mandatory quality certifications for steel products risk creating shortages of critical products, disruptions in healthcare deliveries, and losses of export opportunities, the Association of Indian Medical Devices Industry said in a statement on Thursday, August 28.
The association said that the ministry of steel has mandated mandatory quality certifications for all steel products - finished and semis - that are used for making medical devices and products like syringes, surgical blades, endoscopes.
Previously, foreign suppliers needed certifications from the Bureau of Indian Standards (BIS) only for finished steel products used in the final medical device, but now upstream materials like hot rolled coils and ingots supplied for making the devices would also need quality certifications from the BIS.
Often, medical device making companies need specific imported stainless steel capillary tubes, often in small quantities, that make securing BIS certifications uneconomical and operationally impractical, the association said.
Without the ability to import these critical stainless steel inputs in small quantities, production standards of devices and quality could be at risk, with a loss of global buyers, it added.
It said that domestic steel companies like Tata Steel, Jindal Steel and others cannot consistently make the required grades of steel in the small quantities that are needed by medical device makers.
The medical device manufacturing industry has therefore applied to the ministry of steel seeking that steel used in making medical devices be exempted from requiring mandatory quality certifications from the BIS.