Outsourcing and Manufacturing in Asia In addition to sales, some Western device companies are man

Outsourcing and Manufacturing in Asia

In addition to sales, some Western device companies are manufacturing more cheaply in Asia than in the West. While manufacturing in China recently has gotten more expensive compared with Vietnam and India, the quality of locally made devices in China (from both local and foreign companies) is getting better. In the next five years, even some Class III products will be made in China and India at FDA-approved factories.

The last few years have seen new regulations for product registration and increased regulation for many of the Asian countries (e.g., China’s State Food and Drug Administration). In addition, in some cases international level quality standards for device manufacturing in Asia have been mandated.

In Asia, there is good availability of raw materials and equipment as well as a trained labor force with technical/managerial personnel. These factors should enable international companies to start device manufacturing plants in Asia (or at least utilize more qualified suppliers) in addition to relying on export sales. Also, many Asian governments have set up incentives for device manufacturers looking to export. For example, in some Asian countries, the import of raw materials and capital goods to manufacture medical devices is now duty-free. Other Asian countries waive certain taxes.

With increased regulations and new good manufacturing practice requirements, the quality and standard of medical devices in Asia already has risen considerably and will continue to do so in the future.