The Taiwan Food and Drug Administration is beginning the process of drafting separate medical device regulations for the first time.
Medical devices are currently regulated in Taiwan under the Pharmaceutical Affairs Act, which was enacted in 1993.
The Taiwan FDA said that as other countries have developed laws and regulations specifically for regulating medical devices, it was time the country separated out regulations covering the management of medical devices.
TFDA classifies medical devices into three risk-based categories similar to those used by the U.S. FDA: Class I is low risk; Class II is medium risk and Class III is high risk. TFDA also conducts pre-market assessments of devicemakers’ facilities, audits their quality management systems and conducts post-market surveillance.
The proposed Medical Devices Act will further define the device classification system and will include electronic listing and reporting. The new act will also require devicemakers to annually declare their licensed devices.
Importantly, the new regulations will strengthen the oversight of medical devicemakers and their manufacturing processes. For example, manufacturers will need to establish track and trace mechanisms for their products, and the TFDA will require manufacturers to comply with good manufacturing and good distribution practices.
Manufacturers that design and place devices on the market will be incorporated as device manufacturers. Legal entities that lease devices and service or repair them will be incorporated under medical device distributors.
The new regulations are expected to boost the country’s medical device industry, particularly in the area of life cycle management, TFDA said.
TFDA said it expects a draft of the new regulations to be available for review by the end of this year.