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The last few weeks we are firstly battered by the typhoons, then by the tragedy in Israel and its knock-on effects. Healthcare becomes more important yet more vulnerable to these events, and Access-2-Healthcare continues to bring the up-to-date news from the industry. We encourage you to share this newsletter with your friends and family. We also want to hear from you! If you have any questions or suggestions, please feel free to contact us. |
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Regulation of all Class C & D Medical Devices Under Licensing regime
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The Central Drugs Standard Control Organisation (CDSCO) had set a deadline of October 1 for bringing "class C" and "class D" medical devices, including ventilators, imaging equipment, and surgical robots, under the new regulation. The new regulation to govern all medical devices in India mandates that medical devices under these categories cannot be sold without a manufacturing licence after the dead-line.
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eSTAR - is it working now? |
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While the FDA had announced that submission by the electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal is mandatory. However, technical issues prevent electronic submissions via the CDRH (Center for Devices and Radiological Health) portal. In such cases, impacted submissions would need to be mailed to the CDRH Document Control Center. Did you experience it?
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Thai FDA announces renewal system will be opened |
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The Thailand Food and Drug Administration (TFDA) made an announcement to notify importers and manufacturers in Thailand that the renewal system will be opened starting October 1st, 2023, to December 31st, 2023, for the following certificates:
Establishment Registration Certificate
Sales License
License/ Notification Certificate (applicable for approved products based on the New Regulation)
Listing Certificate (applicable for approved products based on the New Regulation).
For Establishment Registration Certificate, Sales License, License, and Notification Certificate:
Registrant shall submit their applications through the SKYNET FDA system.
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France's new Global Health Strategy |
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France has released its Global Health Strategy for 2023-2027, in Lyon, in the presence of three French Ministers, the Minister for Europe and Foreign Affairs, the Minister of Health and Prevention, the Minister of Higher Education and Research, and WHO’s Director-General.
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The Inter-agency Taskforce on Mental Health and Well-being has launched Singapore’s National Mental Health and Well-being Strategy. The Strategy aims to create an effective mental health ecosystem comprising accessible and good quality clinical care with a supportive community and society, where people with mental health needs can seek help early without stigma and be readily supported for their recovery.
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Research project SPIRAL receives nearly 6 million euros grant to achieve a breakthrough in HIV cure for the people most affected by it. In the project, several (inter)national research groups are working on different themes to achieve a first step towards HIV cures that are safe, acceptable, affordable and, in particular, available worldwide. NWO awarded this grant within the partnership with the AIDSfonds 'HIV cure for all'. The NWO-Aidsfonds partnership is part of the research within the Knowledge and Innovation Covenant (KIC).
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Haemonetics Corporation Announces Definitive Agreement to Acquire OpSens, Inc. |
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Haemonetics Corporation announced that they have entered into a definitive agreement under which Haemonetics will acquire all outstanding shares of OpSens for CAD $2.90 per share in an all-cash transaction representing a fully diluted equity value of approximately USD $253 million. |
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Hexainnoheal develops new home-use medical device 'Flexible PainQ'
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Hexainnoheal has introduced a new product line consisting of two primary devices, PainQ for pain management and CobiQ for rhinitis management. PainQ, is a user-friendly home healthcare device designed to effectively alleviate pain through the integration of Low Level Lasers, LED lighting, and low-frequency stimulation functions.
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Clinical Evaluation Pointers Of Studies and Evaluations
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With respect to Clinical studies, on many occasions there appears to be a misconception where one may expect a medical device company needs to be: - ISO13485 certified
- Have design confirmed or ‘frozen’ - Production in place
Before the devices produced can be used for clinical studies. Well, it’s true in its philosophy, however: The medical device company needs to have a quality management system suitable for medical device design and production. Didn’t say that it needs to be certified at this point_ That said, some key areas to zoom in: post market surveillance setup must be complete (post market clinical feedback), including all adverse event and field action procedures, in case the device in trial meets up with a safety-related issue.
It needs to have the design reach a point of maturity where it is similar or same as the one likely to be released to the market. The design is NOT ‘frozen’, because design can never be frozen’. Therefore, this is thing called ‘change control’. If the device changes for whatever reason and it is significant, then the clinical studies may have to be assessed for impact. This includes all of the contents in the risk management file.
All of these ‘clinical stuff’ ultimately culminates to the Clinical Evaluation Report
Some pointers for the other parts of clinical evaluation:
It’s also very helpful to ‘work backwards’ from the clinical evaluation report, addressing every section. The state-of-the-art format to follow today is the CER format for the EU MDR/IVDR. Then your clinical evaluation plan and study design protocol will become more apparent.
Literature search, review and evaluation – information that would be found in the early stages of the product development, as the device is justifying its existence in the market.
Competitor search – oftentimes due to lack of information or just plain avoidance, the actual competitors are not being placed side by side to compare against the medical device. This is not a ‘beauty contest’, it is to assess if your device is state-of-the-art and whether it represents comparable or better safety/efficacy without introducing an excessive number of hazards to the end-user AND the supply chain.
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Recognized as the world's oldest event (since 1986) focusing on biotechnology and as well medical technology, we attended BioJapan between 11-13 October 2023.
The three exhibitions that make up this event are: 1. BioJapan, the oldest biotechnology show in the world (1986–); 2. Regenerative Medicine JAPAN (2016–), which aims to industrialize and expedite research and development in the field of regenerative medicine, including iPS cells; 3. "health TECH JAPAN" (2020–) offers a combination of life science and digital technology.
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The holiday seasons are here, so get packing and visit some of these MedTech events! |
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