On November 11, 2014, U.S. President Barack Obama announced that China and the United States have come to an agreement to eliminate trade tariffs on information technology products. The announcement was made at the Asia Pacific Economic Cooperation summit in Beijing. The agreement is an extension of the World Trade Organization’s (WTO) Information Technology Act (ITA) and would eliminate tariffs on all products included in the ITA Declaration, which includes medical devices. The agreement has to be approved by all other ITA members before it moves forward. If approved, the agreement is expected to affect around one trillion dollars’ worth of global sales.
China is the world’s largest exporter of high tech products. According to trademap.org, China exported over $550 billion USD worth of electrical and electronic equipment and over $74 billion USD worth of optical, photo, technical, and medical apparatuses in 2013. The United States and China are important trading partners. In 2013, China exported more goods to the United States than any other country.
Though the agreement may make exporting medical devices to the U.S. from China more cost-effective, it won’t necessarily make it easier. Medical devices distributed in the USA are regulated by the U.S. Food and Drug Administration (FDA), and the agency has many requirements for device establishments. A device establishment is required to register with FDA, list all its products, and, depending on the complexity and risk of its devices, it may need to submit information about the safety and effectiveness of the devices. FDA also has a new Unique Device Identifier (UDI) requirement. By 2018, most devices will be required to bear a UDI on their labels. Establishments in China must also designate a U.S. Agent, a representative who resides in the United States and can communicate with FDA on behalf of the foreign establishment.
Registrar Corp can help Chinese establishments take advantage of the potential tariff-free exporting by helping them navigate through the U.S. FDA regulations for medical devices. Registrar Corp’s team of Regulatory Specialists can register a device establishment, list its products, assist with UDI requirements, and function as its U.S. Agent. To learn more about FDA regulations for medical device companies or about what Registrar Corp can do to help, contact us at 1-757-224-0177 or through our Live Help chat service: https://www.registrarcorp.com/livehelp.