The Association of Indian Medical Device Industry (AIMED) has written to the Central Government asking it to impose safeguard duties on 12 key medical device categories, warning of import surge due to lowering of tariffs.
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The Central Drugs Standard Control Organisation (CDSCO) has upgraded its online registration system and has asked all medical device manufacturers to re-submit market standing certificates and non-conviction certificates for registration. The move is aimed at improving ease of doing business and streamlining the regulatory process.
The market standing certificate serves as proof that a manufacturer or importer of medical devices holds a valid license and has been actively engaged in the business of manufacturing, importing, and selling those devices within the Indian market. It’s essentially a document verifying the company’s credibility and compliance with regulatory standards. The non-conviction certificate verifies that a medical device manufacturer or importer has not been convicted of offenses related to the safety, quality, or performance of their devices.
Meanwhile the Association of Indian Medical Device Industry (AIMED) has on Monday written to the Central Government asking it to impose safeguard duties on 12 key medical device categories, warning that uncontrolled imports are putting domestic manufacturers at risk. “With ongoing trade negotiations with the EU and the U.S. likely to lower import duties, Indian manufacturers could face severe injury and capacity underutilization if immediate action is not taken,’’ said the group, warning that delayed intervention could lead to financial distress, job losses, and increased dependence on foreign suppliers.
It added that the steepest rise has been in syringes and needles, where imports skyrocketed 80% from $61 million to $111 million recently, led by China (69%), USA (91%), and Singapore (64%). “Unchecked imports could cripple domestic production and the Government should take immediate action to protect local manufacturers, secure employment, and maintain healthcare self-reliance. As India negotiates lower trade barriers with the EU and the U.S., the risk of market domination by cheaper imports looms large,’’ said a release issued by AIMED.
Published – April 14, 2025 10:32 pm IST
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