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Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says. Read More
Foreign companies seeking to market novel medical technologies in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape. Read More
Foreigners can now own up to 100 percent of existing medical devicemakers in India without first getting government approval, under a carve-out of the country’s foreign direct investment policy for drugs. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More
The Indian government appears poised to expand foreign direct investment by medtech companies as it searches for ways to beef up domestic manufacturing. Read More