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India’s Central Drugs Standard Control Organization has opened up an online portal to multinational companies seeking registration certificates or import licenses for medical devices and diagnostics. Read More
Manufacturers can get earlier access to the market under a new pilot program launched last week in South Korea that unifies the country’s medical device approval review process and the health technology assessment. Read More
India’s medical device industry is urging the government to implement several policy measures — including tariff corrections and a new regulatory regime — to ensure the financial viability of domestic device manufacturing parks in the country. Read More
India’s medical device industry is urging the country’s government to do away with the insistence on U.S. FDA approval in the tendering process for the public healthcare system and to replace it with more democratic options. Read More
The FDA says it has scheduled an inspection with Singapore-based Biosensors International, following an import alert that banned the company’s medical devices. Read More
Australia’s Therapeutic Goods Administration is stressing the need for protocols and procedures to help minimize the risks of using medical devices that run on batteries. Read More
Indian medical device manufacturers are praising the country’s government for its recent decisions to hike the duty on imported devices, reimpose the special additional duty on the imports and reduce taxes on raw material imports. Read More
The U.S. and India are working to develop international standards and technical regulations to bolster trade and reduce logistical and administrative burdens that affect small- to medium-sized enterprises. Read More
China’s FDA has unveiled plans to assemble an expert committee to review and discuss medical device classification, as well as spelling out the rules for using generic names for devices. Read More