Taiwan Medical Device Consulting

The medical device market in Taiwan is worth about $2 billion. Taiwan has a well-developed healthcare system that encourages demand for quality medical devices. Healthcare affordability in Taiwan is supported by a National Health Insurance Scheme that covers every Taiwanese citizen. With good potential in the Taiwanese medical device market, international companies can turn to PBM’s Taiwan medical device consultants for business and regulatory consulting. We have helped many medical devices companies with registering products, finding distributors and establishing joint ventures in Taiwan.

There are more than 500 medical device manufacturers in Taiwan. Most of these are small and medium sized manufacturers that make homecare medical devices such as electronic thermometers as well as blood pressure and blood glucose meters. Most of the high-end medical devices in Taiwan are imported from the US, Japan and Europe. These include diagnostic imaging equipment, IVD products and implant devices.

The medical device market in Taiwan is regulated by the Pharmaceutical Affairs Act. The Taiwan Food and Drug Administration (TFDA) oversees the implementation of the regulations and standards of medical devices via the Division of Medical Devices and Cosmetics. This Division is responsible for areas such as implementing quality manufacturing systems for medical devices, implementing GCP inspections, overseeing product registrations and evaluating clinical trials. International companies that are unfamiliar with Taiwan’s medical device regulations can contact a PBM consultant for professional advice.

With a strong background and experience in medical consulting, PBM’s Taiwan medical device consultants can offer international companies the best solutions to succeed. We possess a thorough understanding and knowledge of the Taiwanese medical device market and its regulations. For inquiries on PBM’s Taiwan medical device consultant services, please contact us or view PBM’s publications to find out more about the Taiwanese healthcare market.