TFDA announces the establishment of the Smart Medical Device Office

The Legislative Yuan passed the third reading of the "Medical Devices Act” on December 13, 2019 and the Act was announced on January 15, 2020 under the Presidential Decree.

In order to promote the development of artificial intelligence and machine learning (AI/ML)-based medical devices and to support the recently implemented Medical Device Act, the TFDA, on the 7th, announced the establishment of the Smart Medical Device Office to provide one-stop consultation services.

The TFDA expressed that AI/ML-based medical devices can be used to assist in patient triage, disease detection and diagnosis to some extent. The establishment of a dedicated regulatory office will accelerate the industry’s understanding of relevant regulations so that developers can incorporate the concept of the product life cycle management into their product design. It will guide the developers to build up the data of product safety, clinical effectiveness and quality so as to accelerate the review process and the launch of AI/ML-based medical devices.

The major duties of the Smart Medical Device Office include: (1) to provide advices on AI/ML-based medical devices; (2) to organize related trainings and campaigns; (3) to establish a platform to provide real-time information; (4) to create a B2B matchmaking platform to help the networking between the IT industry and the healthcare industry; and (5) to study related regulations and strategies so as to create a robust regulatory system for AI/ML-based medical devices.

The TFDA hopes that the establishment of the Smart Medical Device Office will promote the development of the AI/ML-based medical device industry and enhance the competitiveness of the medical device businesses in the international arena.

Date: 2021-05-15
Source: 【2021-05-07/TFDA】International Research-Based Pharmaceutical Manufacturers Association