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.
The HKSAR Government has set out a clear direction and goals for the future development of innovation and technology (I&T) in Hong Kong, leading Hong Kong to become an international I&T centre. The Applied Science and Technology Research Institute (ASTRI) is working to maintain a close connection with the academic community and collaborate to consolidate the upstream competitiveness, vitalise the enthusiasm and initiative of transferring R&D results of the University to applied scenarios, and accelerate the process of implementation and industrialization.
ASTRI and the Hong Kong Baptist University (HKBU) signed a Memorandum of Understanding (MoU) aimed at “Fostering University Cooperation in Technology Transfer” on 22 September 2022 to jointly create a new era of smart living and cross-disciplinary technological development.
The extended cooperation covers the areas of smart traditional Chinese medicine (TCM) service systems, pharmaceutical R&D, Artech, and Fintech, as well as interdisciplinary research and its application, to promote technology innovation and transfer. ASTRI, HKBU and its affiliated institutions will co-develop several cooperation models for R&D, including cutting-edge technologies including AI and big data analysis, as well as intellectual property management and commercialisation.
The MoU was witnessed by the Chairman of ASTRI Board of Directors, and the President and Vice-Chancellor of HKBU; it was signed by the ASTRI’s Chief Executive Officer and the Interim Chief Innovation Officer of HKBU on behalf of both parties on the campus of HKBU.
Under the agreement, the two will enhance collaborative research and promote the transfer and commercialization of technology results. In addition, they will set out their respective intellectual property rights and ownership of R&D results to promote the commercialisation of collaborative R&D or projects implemented by both parties or affiliated institutions of HKBU. In addition, the partnership aims to reduce the R&D time, improve the utilization of resources and accelerate the application of R&D results.
The Chairman of ASTRI’s Board of Directors noted that approximately 100 R&D projects are conducted every year in ASTRI aimed, ultimately, commercialisation. ASTRI proactively collaborates with HKBU to build an R&D commercialisation platform, promote cooperation in an all-around way, and enhance synergy in talents, resources, R&D, etc. Leveraging perspective advantages, the two can create unique R&D conditions in key areas such as pharmaceutical R&D, AI and Fintech, to seize the new opportunities in the I&T era.
The President and Vice-Chancellor of HKBU noted that the transfer of research outcomes is the third mission of universities. HKBU has identified three focused research areas including Creative Media and Practice, Health and Drug Discovery, and Data Analytics and Artificial Intelligence.
The University has also established six interdisciplinary research laboratories to allow all faculties and departments to fully unleash their areas of excellence, stimulate intellectual interaction on common topics, explore and discover new cutting-edge technologies, and provide solutions to cope with challenges in society. The collaboration between HKBU and ASTRI provides abundant opportunities for knowledge transfer of these technologies.
ASTRI and HKBU will cooperate on a project basis to deepen their mutual vision of technology exchange and development. This includes determining the contribution of each stakeholder in the development of R&D results, as well as the ownership, funding arrangements, project implementation responsibilities and intellectual property protection of R&D results of relevant joint projects. This will enable both partners to explore opportunities for technology commercialization with the intellectual property owned by both parties. It will also ensure that local R&D can be effectively turned into applied technologies and enlarge the production capacity.
The Ministry of Science and Technology (MOST) recently launched a series of seminars to kick-start the 2022 Vietnam Artificial Intelligence Day (AI4VN) in Hanoi, earlier this week. The seminars discussed AI solutions in finance banking, training and connecting AI human resources, and automation in production.
Launched in 2018, AI4VN is an annual event held by MOST. It gathers a wide range of stakeholders in the AI community, including policymakers, technology corporations, researchers, and university students. Seminars delve into the development of an AI ecosystem to improve the quality of life and explore solutions to help businesses break through with AI technology.
During the recent event, experts stated that more than 60% of companies operating in the financial-banking sector are testing AI. An official from the Viettel Cyberspace Centre said in the next three years, the accumulation of AI databases will bring great value, contributing to solving many problems.
Pham Hien, a researcher from the Commonwealth Scientific and Industrial Research Organisation (CSIRO)’s Data61, introduced a project on the AI market in Vietnam, which is built exclusively for the formation and strengthening of the AI ecosystem in the nation. It focuses on developing databases and algorithms to automatically collect, store, and update profiles of Vietnamese AI experts at home and abroad; an index to track the development of AI in Vietnam; and business models to enhance research-industry collaboration in the field.
The Deputy General Secretary of the Vietnam Automation Association also spoke at the event. He noted that automation is divided into seven levels, with most businesses in Vietnam now at the level 3-4-5 or partial automation. In the digital era, the traditional business model will be eliminated and replaced by a digital transformation model of corporate governance, he added.
The implementation of the 2022 AI4VN sees the coordination between a Vietnamese online newspaper and Aus4Innovation, an AU $10 million development assistance programme being enacted under the Vietnam-Australia innovation partnership.
According to data from the World Intellectual Property Organisation (WIPO), more than 1,600 Vietnamese are studying and working in AI-related fields. Only about 700 people, including 300 experts, are doing this work in Vietnam. In Vietnam, the supply of AI personnel meets only 10% of the recruitment demand of the domestic market.
According to the Ministry of Information and Communications (MIC), to solve the problem, businesses must recruit experts from abroad, recruit young talents for training, or hire from domestic and foreign training institutions. State-run enterprise Viettel has actively recruited overseas Vietnamese experts and engineers specializing in AI from the US, France, Russia, and South Korea, and cooperated with experts in many countries (US, Japan, Singapore, Finland).
Only about 30% of IT graduates can work in AI, and the rest must be further trained. Experts say that it is necessary to have a professional training programme on AI. Also, instead of considering AI as part of information technology faculties, undergraduate and graduate training programs specialising in AI and data science should be developed. Training at universities is a crucial step in solving staffing problems.
The Media Lab of the Massachusetts Institute of Technology (MIT) has developed a tiny antenna that can wirelessly operate inside a living cell, opening possibilities in medical diagnosis and treatment as well as other scientific procedures due to the antenna’s potential for real-time monitoring and even controlling cellular activity. The Cell Rover technology represents the first demonstration of an antenna that is compatible with 3D biological systems and can operate inside a cell.
Typical bioelectronic interfaces are millimetres or even centimetres in size and are not only highly invasive but also lack the resolution required to wirelessly interact with single cells. This is especially problematic given that changes to a single cell can have a profound effect on the entire organism.
The researchers have created an antenna that is much smaller than a cell. In fact, the antenna represented less than .05 per cent of the cell volume in the team’s research with oocyte cells, well below the size that would intrude on and damage the cell.
On the other hand, a significant challenge was figuring out how to build an antenna of that size that could work inside a cell. This is because conventional antennas must be the same size as the wavelength of the electromagnetic waves they transmit and receive. Such wavelengths are extremely long, and they represent the velocity of light divided by the frequency of the wave.
Simultaneously, increasing the frequency to reduce that ratio and the size of the antenna is counterproductive because high frequencies generate heat that is harmful to living tissue. The antenna developed by Media Lab researchers converts electromagnetic waves into acoustic waves, whose wavelengths are five orders of magnitude smaller than those of electromagnetic waves (representing the velocity of sound divided by the wave frequency).
This conversion from electromagnetic to acoustic waves is accomplished by fabricating miniature antennas out of magnetostrictive material. When a magnetic field is applied to the antenna, it is powered and activated.
Magnetic domains within the magnetostrictive material align to the field, causing strain in the material, like how metal bits woven into a piece of cloth might react to a strong magnet, causing the cloth to contort.
The variable strain and stress (pressure) produced in the material by the application of an alternating magnetic field to the antenna is what generates the acoustic waves in the transmitter. In this configuration, the antenna might be utilized to investigate the fundamentals of life as natural processes unfold. In lieu of destroying cells to analyse their cytoplasm, the Cell Rover may monitor the development or division of a cell in real-time and in vivo, detecting different chemicals and biomolecules, such as enzymes, or physical changes, such as changes in cell pressure.
With such capabilities, the Cell Rovers could be useful, for instance, in cancer and neurological disease studies. The technology might be used to detect and monitor biochemical and electrical alterations linked with the evolution of the disease in individual cells.
The method, when applied to the realm of drug development, might illuminate the reactions of living cells to various medications. With its small antenna, the Cell Rover may perform duties ranging from intracellular computation and information processing to autonomous cell exploration and modulation. Multiple Cell Rovers can communicate among themselves and with the outside world, even within a single cell, as shown by the research.
The researchers called their intracellular antenna device Cell Rover to evoke the exploration mission of a Mars rover.
As the global population continues to age, neurological conditions like Parkinson’s disease, Alzheimer’s disease and cerebral small vessel disease impose heavy socioeconomic burdens. To advance diagnostic and treatment methods, pathological processes must be studied via the use of animal disease models and human brain tissues. However, currently available techniques for the visualisation of brain structures are limited and costly.
Aimed at overcoming this challenge, the Margaret K.L. Cheung Research Centre for Management of Parkinsonism at The Chinese University of Hong Kong (CUHK)’s Faculty of Medicine (CU Medicine) has developed a fast, user-friendly technique to make chemically stabilised antibodies for rapid labelling and imaging of molecules in biological tissues. The research findings have been selected as the cover story in the latest issue of the renowned peer-reviewed journal Nature Methods.
Technologies that enable the visualisation of biological tissue structures are crucial for the study of organs, like the brain, and their functions both in normal conditions and when suffering from a disease. A technique called immunostaining, which uses antibodies to target biological molecules in tissues, is immensely powerful and widely used for such purposes. However, antibodies cannot reach deep into the tissues, hindering their application to high-throughput, three-dimensional structural studies.
A research team led by Dr Lai Hei-ming, Assistant Professor in CU Medicine’s Department of Psychiatry and Principal Investigator of the Margaret K.L. Cheung Research Centre for Management of Parkinsonism; and Dr Ko Ho, Assistant Professor in CU Medicine’s Department of Medicine and Therapeutics and the School of Biomedical Sciences, and Associate Director of the Margaret K.L. Cheung Research Centre for Management of Parkinsonism, invented a 3D immunolabelling strategy named ThICK (thermal immunohistochemistry with optimised kinetics) staining to overcome the limitation.
Usually, antibodies are sensitive to heat and chemicals called denaturants. When used in immunostaining, these properties limit the choice of temperature and denaturants, since they can destabilise the antibodies and make them lose their functions.
Therefore, the team developed a chemical technology that can convert commercially available antibodies, making them much more resistant to heat and denaturants. The heat-stable antibodies, termed SPEARs (synergistically protected polyepoxide-crosslinked Fab-complexed antibody reagents), can be used to achieve immunolabelling of biological molecules deep inside intact tissues by flexibly choosing different incubation temperatures and denaturing chemicals. The use of SPEARs in ThICK staining can help to overcome the limitations of deep 3D immunostaining and optimise the visualisation of brain structures.
The new chemical technology enables an innovative approach that is rapid, simple, and highly scalable. The study shows that ThICK staining with SPEARs can achieve whole mouse brain immunolabelling within 72 hours; when applied to human brain tissues, it can achieve fourfold deeper penetration with threefold fewer antibodies.
ThICK staining achieves whole organ immunolabelling faster than other state-of-the-art methods, from requiring one to eight weeks for each round of antibody staining to a much shorter time of one to three days.
The new tech is compatible with a wide range of commercially available antibodies, and different classes of tissue preservation and clearing methods. It can therefore be readily implemented in most laboratories.
Dr Ko remarked that SPEARs technology will particularly aid in the study of neurodegenerative diseases. It is hoped that the work can accelerate the path towards new tools for disease diagnosis and treatment paradigms in the future.
The study was also funded by the Croucher Foundation, the National Natural Science Foundation of China, the Innovation and Technology Commission, and the Research Grants Council of Hong Kong.
The information from numerous ministries and institutions, even local governments, will now be combined into one website. The aggregator website Indonesiakini.go.id has been launched by the Ministry of Communication and Information.
This action will make it simpler for the public to obtain reliable information on the numerous policies and initiatives that the government has implemented and will continue to implement.
“We hope that with this website, the public can find out the current situation, and condition of Indonesia by just clicking on one website. The existence of this website makes public communication more integrative, more orchestrated in the eyes of the citizens,” says Usman Kansong, Director General of Information and Public Communication of the Ministry of Communications and Information Technology.
The Director General outlined how Indonesia’s presence will undoubtedly address the difficulties of rapid, widespread, and integrated public communication. He continued by saying that the dynamics of information and communication technologies that cause the disruption make it difficult for government institutions to handle public information and communication in a way that allows for adaptive public consumption.
It must be acknowledged, nonetheless, that not all local governments, organisations, or ministries have combined their material into a single repository. Communication activities must be adjusted to the changing public communication landscape in government institutions to facilitate the public’s access to information.
The Ministry of Communication and Information has the responsibility to coordinate the planning, preparation, and implementation of public communications related to policies and programmes of the government, in accordance with Presidential Instruction Number 9 of 2015 concerning the Management of Public Communication.
The Ministry is also responsible for organising information into a single narrative for the Presidential Instruction. The presence of Indonesia will undoubtedly be the ideal setting for bringing together the various government channels.
The public will now have easier access to information about the government’s development initiatives. The four information channels held by the Ministry of Communication and Informatics will soon be integrated into the Indonesian aggregator website.
This includes 115 universities, 34 provincial governments, 98 city governments, and 416 district governments. There are also 37 additional ministry sites, 7 institutions, 2 sites run by the presidential palace, and 37 other sites.
Indonesia has collected 588 websites belonging to various institutions, local governments, and ministries. 746 locations total, or 79 per cent of the target, have been reached.
Meanwhile, residents of South Sulawesi, particularly Makassar City, are prepared for the end of analogue television broadcasts and the subsequent transition to digital television broadcasts. In July 2022, periodic opinion polls performed by the Ministry of Communication and Information confirmed this readiness.
Rosarita Niken Widiastuti, a member of the Minister of Communication and Information’s Special Staff, reported that 82.94 per cent of Makassar and its surrounding residents were interested in viewing Digital TV broadcasts.
The willingness of the citizens of Makassar City cannot be separated from the contribution of the performance of the Broadcasting Institution. All 18 analogue broadcasting institutions in Makassar City and its surroundings have transitioned to digital broadcasting.
Furthermore, the Director of Broadcasting of the Directorate General of Post and Information Technology at the Ministry of Communication and Information, Geryantika Kurnia, noted that there are three determinants of readiness prior to the implementation of the Analogue Switch Off (ASO) programme.
According to the Director, 112 Service Areas are affected by ASO in Indonesia due to the prevalence of analogue television broadcasts. LPP TVRI, the Indonesian public television network, is actively constructing infrastructure for the remaining rural sites, of which 90 are already receiving digital transmissions.
A new smart planter is set to provide a simple and efficient way to green buildings and surfaces where conventional planting is impossible. Griffith University PhD student Majed Abuseif has just been announced as a finalist in the QBE AcceliCITY Resilience Challenge for his project using artificial intelligence and simulation models to incorporate green infrastructure into building and the urban environment. The global competition seeks entrepreneurs whose ventures use smart city solutions to address risk, equity and sustainability in our urban environments and has narrowed it down to the ten best solutions.
Working as an architect and landscape architect, the scientist’s PhD focuses on the implementation of trees on buildings, and building science and environmental simulations. He noted that the smart planter box enables us to green buildings and surfaces, indoors or outdoors, in any environment. It is a novel modular system capable of supporting standard plants and trees.
Scientists have been working to redress the growing ecological imbalance caused by urban development by incorporating certain types of green infrastructure such as green roofs and walls, but unfortunately, the technologies available to date have been limited and need infrastructure to host them.
Putting plants on buildings generally presents risks that hinder their implementation, such as plant roots, wind loads, waterproofing, irrigation requirements and other problems. The scientist engaged with industry partners and worldwide experts trying to integrate trees on buildings by incorporating rooftop gardens. He found some traditional technologies that could be used on buildings and then started developing a design based on a modular system that can be put on any surface and any location.
The planter box can be integrated into existing infrastructure, or act as a stand-alone planter. It can calculate anything the green infrastructure needs – from the amount of water the plant needs, to the temperature of the leaves, or even how it will perform inside the built environment.
The system can even be connected to Smart Cities and Smart Building models, so councils and developers can obtain better insights on climate change and urban heat islands to help with the development of mitigation strategies.
The smart planter box is a closed system so it can mimic any environment. The planer’s development could place the system in a forest and develop it to mimic a bushfire situation, so when there is a risk of a bushfire it will give us the alarm and we could act before a disaster happens.
As a result, the system has a water compartment, it can harvest water, so it can also help mitigate stormwater flooding issues in the city. The team can even use this system to predict the energy consumption of buildings and validate the environmental aspect of a building.
Architects will be able to use this as a design tool and a research tool, which will help in designing sustainable buildings as well as monitoring them. The next step is to deliver my skills and design for people around the world, helping to save the planet and enhancing people’s lifestyles.
The Department of Information and Communications Technology (DICT) recently taught people with disabilities (PWDs) how to be digitally literate. According to Johanna F. Tulauan, DICT provincial officer, the Digital Literacy Training was part of their duty to implement a Specialised ICT Training Programme aimed at meeting the unique demands of diverse industries across the nation.
The DICT officer added that the training aims to provide participants with basic information on ICT-related subjects that will enhance their knowledge and, in the long run, provide them with opportunities for employment or entrepreneurship; aid the government in bridging the digital divide while bolstering inclusiveness among the special needs sectors of the nation.
It will also bridge digital literacy gaps to determine which target groups across different sectors have the greatest needs and where the greatest benefits could be obtained for individual groups and for society, and it will empower both urban and rural-based marginalised groups across different sectors by enhancing their ICT capabilities and by promoting the greater use of the internet and technologies in their daily activities. The training included both lectures and hands-on exercises on Computer and Internet Essentials, Productivity Tools, and Troubleshooting and Networking Fundamentals.
Similarly, the Department of Education has set up ICT programmes like the Learning Resource Management and Development System, an online library with free teaching and learning materials that can be downloaded, and ICT literacy programmes for primary and secondary education.
The Bureau of Alternative Learning System is part of the Department of Education. Its Community Learning Centres offer free education to young people who are not in school, including those with disabilities. These learning centres offer basic computer classes on how to use technology.
In the meantime, the Department of Social Welfare and Development (DSWD) has announced that the online platform for the registration and licensing of Social Welfare and Development Agencies (SWDAs) and accreditation of social welfare development programmes and services are now available following the re-launch of the improved DSWD Regulatory eServices.
The DSWD Regulatory eServices enable SWDAs to submit requests with the required documentation and to receive real-time updates on their application status. In addition, data confirmations are implemented to reduce the likelihood of human error and ensure that only precise information is kept.
In addition, Secretary Erwin T. Tulfo physically navigated the actual online registration process for an SWDA account to observe how the platform operates.
The Secretary commended the DSWD Standards Bureau and the Information and Communications Technology Management Service for pioneering the development of the online platform as part of the Department’s efforts to institutionalize digitalization in the delivery of social protection programs.
The upgraded DSWD Regulatory eServices will act as the nation’s consolidated database, facilitating the generation of reports, monitoring of status, applicant profiling, and application filing by Social Welfare and Development Agencies (SWDAs). This is one of the things being done to change how basic services are delivered, and it looks at a national health emergency where physical separation is strongly recommended.
The Secretary also praised and acknowledged the essential functions of the SWDAs in the provision of social welfare services to Filipinos. With the improvement of the DSWD Regulatory eServices, the Department strives to assure the accuracy of the data and information on the Registration, Licensing, and Accreditation of SWDAs and to give SWDAs and Non-Governmental Organisations with digital access to the Agency’s regulatory services.