New Taiwanese Medical Device Regulations Set for May 2021

The Taiwanese government plans to launch new medical device regulations on May 1, 2021, ushering in new requirements for unique device identification (UDI), distribution and other processes.

The Medical Devices Act (link in Chinese) establishes a new medical device regulatory framework in Taiwan via a phased implementation schedule. Some key elements of the new regulation to be enforced by the Taiwan Food and Drug Administration (TFDA) include:

• UDI: As previously reported by Emergo, Taiwan’s UDI requirements will be rolled out in three phases—June 2021 for high-risk Class III implantable devices, June 2022 for Class III non-implantable devices, and June 2023 for moderate-risk Class II devices.
• Class I devices: Some low-risk Class I devices will undergo less onerous listing rather than full registration with TFDA in order to be marketed in Taiwan.
• Good Distribution Practice: The new regulation will establish Good Distribution Practice (GDP) requirements for manufacturers as well as distributors, importers and license holders. Emergo sources in Taipei believe TFDA will grant a two-year grace period for affected entities to obtain GDP certification and maintain their Taiwan market activities.

Emergo consultants in Taipei will provide additional details on Medical Devices Act implementation progress as they become available.

Additional Taiwan medical device market resources from Emergo by UL:

• Taiwan medical device registration and approval consulting
• Taiwan Agent in-country representation
• Taiwan medical device vigilance reporting