Stryker Corp. (NYSE:SYK) is betting on the Chinese market with a three-legged approach epitomized by the recent launch of a fully outfitted mobile training center.
Exports
India’s medical device approvals stalled
By Stewart Eisenhart, Emergo Group
Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all product approvals until the director’s reappointment.
New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays
By Stewart Eisenhart, Emergo Group
A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays.
Mexico to ease IVD registration process
By Stewart Eisenhart, Emergo Group
Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.
Help wanted: Boston Scientific to hire 250
Boston Scientific Corp. (NYSE:BSX) plans to hire 250 new employees for its manufacturing operation in Latin America, according to a report from Costa Rica.
The Natick, Mass.-based medical device maker is expanding its engineering, production, quality control and process development roles in Heredia, just outside the capital city of San José. BSX also has a plant in Alajuela, Costa Rica, according to Inside Costa Rica.
HeartWare notches reimbursement win in France
HeartWare International Inc. (NSDQ:HTWR) won full reimbursement from the French government with publication in an official journal there.
That means French heart patients implanted with the Framingham, Mass.-based company’s ventricular assist device will be covered by that country’s national health care system effective July 4, according to a regulatory filing.
FDA issues advisory on medical device components imported from Japan
By Stewart Eisenhart, Emergo Group
The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
Asian regulatory update: Medical devices in Malaysia to register with Health Ministry
Medical devices in Malaysia to register with Health Ministry
Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in June 2011.
The new Medical Devices Act will require imported and local medical devices to be registered with the Health Ministry of Malaysia. This is to ensure quality products in medical treatments, as well as to legally protect the medical devices under the country’s patent law. Currently, registration of medical devices is not mandatory in Malaysia.
Japan medtech council pushes for device-specific regulations
By Stewart Eisenhart, Emergo Group
The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharmaceutical Affairs Law (PAL).
Stentys widens footprint in Europe
Stentys SA (EPA:STNT) is looking to branch out in Europe, seeking new markets for its stents designed to treat heart attacks.
The Princeton, N.J.-based company said it’s launching its products in Scandinavia, Spain, Switzerland and Poland. The devices are already on the market in Germany and the Netherlands, according to co-founder and CEO Gonzague Issenmann.
Japan earthquake hurts medical device makers
In Japan, they’re dealing with a death toll sure to rise above 10,000, rolling blackouts and a nuclear disaster of as-yet-undetermined proportions. On Wall Street, investors in medical device makers are contending with issues of their own, as share prices slide and the long-term impact of the Japan earthquake remains unknown.