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Dear Access-2-Healthcare Newsletter Subscribers,
As we step into the dawn of a new year, we bring you the latest updates and insights in the ever-evolving landscape of medical devices. In this month's newsletter, we are focusing on a balanced view on key trends, breakthroughs, and regulatory developments shaping the medical device industry, curated to keep you informed and inspired in your pursuit of excellence.
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MHRA unveils roadmap for new medical device regulations in the UK
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On 9 January 2024, the MHRA released a Roadmap towards the future regulatory framework for medical devices. This provides an update on the intended timelines to implement the future core regulations. The government intends to introduce new regulations for medical devices that prioritize patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators.
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Regulatory fee revision for health products |
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The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and efficacy. There are fees in place to help cover the cost of registration, licensing, notification and permit issuance for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, cell tissue and gene therapy, oral dental gums and retail pharmacies. With effect from 1 July 2024, a fee increases averaging 5% will be implemented, with a minimum increase of $1 and capped at $200 per fee item. This fee revision is necessary to recover part of the costs for the services rendered to businesses.
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WHO cancels delivery of medical supplies to north Gaza |
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The World Heath Organization (WHO) cancelled a mission to bring medical supplies to northern Gaza due to security concerns. WHO had previously attempted this mission three times since December 26. The WHO office in the occupied Palestinian territories expressed concern about the difficulties in delivering medical supplies regularly and safety to northern Gaza due to heavy bombardment, movement restrictions, and interrupted communications. WHO Director – General Tedros Adhanom Ghebreyesus highlighted the urgent health needs and devastation in northern Gaza.
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The Ministry of Health (MOH) is inviting private healthcare operators to participate in an industry consultation for a new not-for-profit private acute hospital model. The industry consultation will be held from January to April 2024. |
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2023 is the first year to fully implement the spirit of the 20th National Congress of the Communist Party of China. The Party Central Committee with Comrade Xi Jinping as the core leads the comprehensive construction of a modern socialist country on a new journey. Epidemic prevention and control has turned smoothly, my country's economy continues to rebound and the medical device industry is accelerating towards the goal of high-quality development. Various departments have successively introduced relevant policies to support and ensure the high-quality development of the industry. Strong domestic market demand has provided strong support for industrial development. Listed medical device companies have performed steadily, industrial concentration has further increased, and innovative achievements have accelerated, better satisfying the needs of the industry. The health needs of the people. At the same time, the export scale of my country's medical device products has returned to normal, the structure of export products has been optimized, and international competitiveness has gradually increased, demonstrating the broad space and strong momentum for the development of China’s medical device industry.
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Veracyte Announces Preliminary Full-Year 2023 Results, Acquisition of C2i Genomics to Add Minimal Residual Disease Capabilities to Its Novel Diagnostics Platform |
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SOUTH SAN FRANCISCO, Calif. - (BUSINESS WIRE) - Jan. 8, 2024 - Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2023. The company also announced it has reached a definitive agreement to acquire C2i Genomics, Inc. a minimal residual disease (MRD) detection company, adding whole-genome MRD capabilities to its novel diagnostics platform and positioning Veracyte to expand its offerings along the cancer care continuum. Under the terms of the agreement, Veracyte will pay $70 million in Veracyte shares at closing, and up to an additional $25 million based on the achievement of future performance milestones over the next two years, payable in Veracyte shares or cash at Veracyte’s election.
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Pioneering research aims to improve bowel function after injury.
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Thousands of people paralysed after a spinal cord injury could benefit from major new UK research which brings together a coalition of charities, hospital and university researchers.
The potentially life-changing ImPRESS project at the London Spinal Injuries Centre (LSIC) will look at whether spinal cord stimulation technology can help recover bowel function.
Spinal Research, the UK’s leading charity funding world-class medical research into restoring movement and function following a spinal cord injury, is driving clinical pilots in this area.
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Importance of Technical Knowledge on Products |
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One of the most frustrating things about regulatory affairs is rounds upon rounds of questions, with each round getting increasingly in depth to the point of sharing confidential intellectual property! How many feel this way? Say “I”
Have you ever wondered why?
One of the simplest ways is to understand the LINE of questioning – that means the trend of the topics asked during these numerous rounds.
Are they about legal documents? Or technical documents?
If the questions are legal in nature, are they checking for consistency, or on the authenticity of the legal documents? Such cases, although frustrating, can be resolved by ensuring that the documents are consistent across – company name, address, responsible person, and so forth. Sometimes there may be a need to have an explanation letter of there are several parties especially external parties involved. However, all of the above needs to be prepared BEFORE submission.
If the questions are technical in nature, yes, they can check for consistency as well. If that is the case, you got off easy! The crux of these questions that they become increasingly in-depth and, hey, didn’t you ask this question?
Usually there are more than one question, try to separate these questions into individual topics, for example, verification & validation, essential requirements, permissible variants, and so forth. to track with each round of questions, where are the questions asked? Are they repeating the question or asking the same question in a different way?
This tracking and information will become important when the project drags on without an end in sight, and there may be a need to have a more serious discussion with the regulatory authority. This tracking will be a good starting point because it did not contain any new or altered information, and it is a track of the reviewers’ own work.
If you are still confused about how this works, just contact us.
Try it and see if it makes sense for the regulator to just stop the merry-go-round and approve your device!
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