In the age of digital, having a digital submission is timely. The Taiwan Food and Drug Administration (TFDA) launched a new online pre-market application platform for medical devices. They named it the TFDA Medical Device Premarket E-submission System.
The new online submission system is aimed to speed up the process. It provides manufacturers with an alternative way to submit pre-market application documents. This should improve the convenience of pre-market applications for medical devices.
Moreover, it’s going to be a more energy-saving way to help the planet. Going paperless means saving the resources required to prepare paper documents. TFDA encourages but does not compel manufacturers to submit pre-market applications for class II and III medical devices through this new system.
According to the Medical Devices Act, an application shall be filed with the central competent authority (TFDA) for the manufacture and import of medical devices for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device licence is issued.
It shows how committed the agency is to its mandate. To date, it has always been continuously improving the pre-market review of medical devices in accordance with international regulations. With the advancement of network technology and the demand for electronic remote applications, TFDA has started developing an electronic document submission mechanism for pre-market applications for medical devices in 2018.
Now that things are ironed out, it has launched its online system for the benefit of manufacturers. The Medical Devices Act is quite recent as it took effect on May 1, 2021. On the other hand, the TFDA accelerated the development of the E-submission System and officially launched the system this year 2022.
At the same time, information such as the “Implementation Instructions for the Application for E-Submission of Class II and III Medical Device Registration”, the system user manual and common Q&A have also been released. Medical device manufacturers or dealers can choose to apply for Class II and III Medical Device registration.
Also, they can do alterations to the registration or factor licence extension through this E-Submission system. Details can be found in the “TFDA Medical Device Premarket E-submission System for Class II and III Medical Device Registration” area of the TFDA official website.
The TFDA, an agency within the Ministry of Health and Welfare, was established in 2010. The organisation oversees food, drug and medical device safety and quality. Plus, its job includes dealing with risk assessment and inspections to ensure the welfare of its people. That means overseeing market approvals for foods, biotech products, cosmetics, drugs and medical devices.
The Division of Medical Devices & Cosmetics is in charge of the safety and quality control of:
- medical devices
- medical device regulation
- clinical diagnostics
- in vitro diagnostic products (IVDs)
Indeed, digital transformation can change lives for the better. That is certainly the case for Taiwan. For instance, Taiwan University recently held food training via Virtual Reality (VR) that allows the learning institution to teach their students to handle equipment even when the equipment itself hasn’t arrived yet.
