On June 24, 2008, Vietnam and the United States signed a memorandum of understanding (MOU) to enhance the safety of medical devices, drugs, food, and feed traded between the two nations. This MOU is a result of discussions between senior Vietnamese officials... Read More
With recent drug troubles such as heparin imported from China, the US government has proposed a Globalization Act to perform more regular inspections of companies that produce food, drugs, and medical devices overseas. In addition to increased domestic inspections, the bill calls... Read More
Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.... Read More
After 10 months of lengthy discussions and meetings, South Korea and the United States have finally wrapped up an epic free trade agreement. Among the various industries, the FTA also included provisions on the pharmaceutical and medical devices markets. Among these provisions... Read More
The US and Japan are currently working to expedite medical device approvals through the “Harmonization by Doing” (HBD) initiative. The HBD program was launched in December 2003, with its first meeting held in December 2005. A second meeting will take place in... Read More
The Chinese government has agreed to take action to eliminate redundancy in testing and certification for medical devices imported into China. China agreed that it would eliminate all duplicative testing and certification requirements for medical devices by the end of May 2006.... Read More
The U.S. International Trade Commission will be conducting a fact-finding investigation into the competitive conditions in Japan and other foreign markets for medical devices and equipment. The investigation will focus on comparing the regulatory environment in Japan with those of other countries... Read More
The National Trade Estimate (NTE) Report released in April 2003 by the Office of the US Trade Representative (USTR) recently criticized South Korea’s trade barriers and lack of communication between the Korean government and multinational pharmaceutical companies. Based on the strong language... Read More
Opportunities in China for medical device manufacturers have never been better. U.S. medical device exports to China are growing 12 percent annually. Sales to the Chinese mainland (excluding Hong Kong) reached US$275 million in 2001. U.S. exporters achieved an additional US$250 million... Read More
Taiwan’s Quality System Documentation (QSD) system requires device manufacturers to pass a “paper audit” before medical devices can be registered in that country. QSD is part of Taiwan’s Good Manufacturing Practices (GMP) system, implemented for medical devices in early 1999. Under Taiwan’s... Read More