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Hurray for Warmer Weather! |
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May is considered as Mental Health Awareness Month. Throughout the world, people from every background, both the young and old, are affected. Towards the end of the month, Memorial Day is celebrated in the United States, which also means summer is soon!
Here is this month’s MedTech Gateway from Access-2-Healthcare to help keep you up-to-date with medical device technology. |
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The Medicines and Healthcare products Regulatory Agency (MHRA) has updated file 'Medical device stand-alone software including apps' which has information on when software applications are considered to be a medical device and how they are regulated. It now includes information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
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Medical devices software applications guidelines update |
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Decisions of 57th Meeting of Medical Device Board |
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The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 57th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers.
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On Monday, February 20, 2023, given the impact of COVID-19, the conference was held online about the 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning in Japan.
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The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning |
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HMI Group and MHC join forces to deliver seamless patient journeys and better health outcomes through technology
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Health Management International Pte Ltd (“HMI Group”), a regional healthcare provider, has entered into an agreement to fully acquire MHC Asia Group Pte Ltd (“MHC”), a leading medical benefits administrator and healthcare technology platform in Singapore.
This will place the HMI Group in a better position to address some of the key challenges that Singapore’s healthcare sector is expected to face over the coming years, including a rapidly ageing population, rising healthcare costs and a growing prevalence of chronic diseases.
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UNITED KINGDOM & AUSTRALIA
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Countries launch programs and services to guide the healthcare sector |
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In the UK, the NHS AI Lab in NHS England has funded the creation of a central source of regulatory and best practice guidance related to AI and digital technology in health and social care,
Down in Australia, applications are now open for CSIRO’s 10-week Innovate to Grow program, which provides small and medium enterprises (SMEs) with the knowledge and tools to better identify and understand their R&D opportunities in the health and medtech sector.
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Korea-U.S. High-Tech Alliance to Set Global Standards
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On the occasion of the state visit of President Yoon Suk Yeol, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) met with Dr. Robert M. Califf, Commissioner of the US Food and Drug Administration (FDA) to discuss cooperation between the two organizations in the field of digital health and signed a Memorandum of Cooperation (MOC*) to strengthen cooperation on medical products using artificial intelligence (AI).
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Post Market Considerations _ Capital equipment vs consumables _
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When the product reaches the customer, this is when the actual access to healthcare begins. There are the various after-market considerations any manufacturer or distributor needs to have. The two main groups of medical devices are capital equipment and consumables. The approach to after-market is very different.
Consumables are concerned about the continued availability, at times its sterility, and the appropriate disposal of them. Capital equipment (not restricted to large equipment, small equipment or software is considered the same) would have to consider device training, maintenance and servicing, and device upgrading.
But both classes would have some similar needs, such as the regulatory considerations (product feedback and complaints, adverse events) just that it its disposition may also be different.
For example, the way to deal with consumables for product recall may include appropriate disposal, but in capital equipment it may involve either returning to the manufacturer, exchange, or on-site repair. Either case, the logistical considerations are very significant.
A manufacturers and distributors’ resources would need to adjust accordingly. For example, service staff for capital equipment.
Sometimes this may be remote (e.g., for software as a device, or well-designed capital equipment that can be serviced remotely) Some distributors may have capital equipment that requires consumables as well, and they would have their hands full!
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Enjoy the lovely weather and start traveling to these MedTech events to open up new horizons. |
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