Medical Devices in Taiwan: Regulatory Requirements

The Bureau of Pharmaceutical Affairs, Under the Department of Health (DOH), regulates medical devices in Taiwan. Devices are classified into three classes. Class I consists of devices that are not life supporting or life sustaining and which do not present unreasonable risk of illness or injury. Class II devices are those for use in supporting or sustaining human life. Class III devices are those that are life supporting or life sustaining or those for a use that is of substantial importance in preventing impairment of human health. Class III also includes devices that may present the potential for unreasonable risk of illness or injury. Taiwan’s classification system follows the USFDA’s framework, so that understanding the classification system “should” be straightforward for U.S. manufacturers. However, there are some issues that can make entering the Taiwanese market difficult for some medical device companies.

First, Taiwan has a maximum 24-per-year quota on medical device registrations for new devices and new usage indications. The backlog created by this quota can lead to serious delays and may cause some foreign manufacturers to bypass Taiwan’s market. Second, there are rumors that the DOH is considering mandating local clinical trials to assist in physician training. This would make Taiwan too difficult and costly a market for many firms to enter. However, U.S. Department of Commerce officials recently pressed the DOH on this issue and were told that the U.S. position would be seriously considered. Third, the DOH requires “Quality System Documentation Approval (QSD)”, or “paper audits” of device manufacturers’ facilities. Without QSD, your registration will not be approved. Finally, Taiwan’s Bureau of National Health Insurance has very low reimbursement rates for devices, leading to depressed market share and sub-optimal medical device usage in that country.

Despite these difficulties, Taiwan is an important market. Taiwanese are wealthy and will pay for their medical needs.