Search
Close this search box.

We are creating some awesome events for you. Kindly bear with us.

Taiwan Launches Digital Submission System for Medical Devices

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.

PARTNER

Qlik’s vision is a data-literate world, where everyone can use data and analytics to improve decision-making and solve their most challenging problems. A private company, Qlik offers real-time data integration and analytics solutions, powered by Qlik Cloud, to close the gaps between data, insights and action. By transforming data into Active Intelligence, businesses can drive better decisions, improve revenue and profitability, and optimize customer relationships. Qlik serves more than 38,000 active customers in over 100 countries.

PARTNER

As a Titanium Black Partner of Dell Technologies, CTC Global Singapore boasts unparalleled access to resources.

Established in 1972, we bring 52 years of experience to the table, solidifying our position as a leading IT solutions provider in Singapore. With over 300 qualified IT professionals, we are dedicated to delivering integrated solutions that empower your organization in key areas such as Automation & AI, Cyber Security, App Modernization & Data Analytics, Enterprise Cloud Infrastructure, Workplace Modernization and Professional Services.

Renowned for our consulting expertise and delivering expert IT solutions, CTC Global Singapore has become the preferred IT outsourcing partner for businesses across Singapore.

PARTNER

Planview has one mission: to build the future of connected work. Our solutions enable organizations to connect the business from ideas to impact, empowering companies to accelerate the achievement of what matters most. Planview’s full spectrum of Portfolio Management and Work Management solutions creates an organizational focus on the strategic outcomes that matter and empowers teams to deliver their best work, no matter how they work. The comprehensive Planview platform and enterprise success model enables customers to deliver innovative, competitive products, services, and customer experiences. Headquartered in Austin, Texas, with locations around the world, Planview has more than 1,300 employees supporting 4,500 customers and 2.6 million users worldwide. For more information, visit www.planview.com.

SUPPORTING ORGANISATION

SIRIM is a premier industrial research and technology organisation in Malaysia, wholly-owned by the Minister​ of Finance Incorporated. With over forty years of experience and expertise, SIRIM is mandated as the machinery for research and technology development, and the national champion of quality. SIRIM has always played a major role in the development of the country’s private sector. By tapping into our expertise and knowledge base, we focus on developing new technologies and improvements in the manufacturing, technology and services sectors. We nurture Small Medium Enterprises (SME) growth with solutions for technology penetration and upgrading, making it an ideal technology partner for SMEs.

PARTNER

HashiCorp provides infrastructure automation software for multi-cloud environments, enabling enterprises to unlock a common cloud operating model to provision, secure, connect, and run any application on any infrastructure. HashiCorp tools allow organizations to deliver applications faster by helping enterprises transition from manual processes and ITIL practices to self-service automation and DevOps practices. 

PARTNER

IBM is a leading global hybrid cloud and AI, and business services provider. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Nearly 3,000 government and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and business services deliver open and flexible options to our clients. All of this is backed by IBM’s legendary commitment to trust, transparency, responsibility, inclusivity and service.