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Dear Esteemed Clients and Partners,
As March unfolds, we at Access-2-Healthcare are delighted to extend our warmest greetings to you. It's with great anticipation and excitement that we welcome the new month, filled with opportunities for growth, innovation, and collaboration in the realm of medical devices. In this edition of our newsletter, we are thrilled to bring you the latest updates, insights, and developments from the world of medical devices consultancy. From regulatory updates to industry trends, our aim is to keep you informed and empowered as we navigate the dynamic landscape together. As always, our team remains committed to providing exceptional service and support to meet your needs and exceed your expectations. We are dedicated to helping you navigate the complexities of the medical devices industry with confidence and clarity. Thank you for your continued trust and partnership. Together, let's make March a month of progress, success, and advancement in the field of medical devices.
Warm regards,
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Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2024/815 and (EU) 2024/817
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On 8 March 2024, Commission Implementing Decision (EU)
2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for single-use medical gloves, biological evaluation of medical devices, sterilization of healthcare products, packaging for medical devices to be sterilized in the final packaging and reprocessing of healthcare products was published in the Official Journal of the European Union.
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MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) |
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On March 12th 2024 the Medical Device Coordination Group published MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.
This is essential reading for those involved in setting out the rationale objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation. The Clinical Investigation Plan is a corner stone document for Competent Authorities and ethics committees to review.
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Gazette of the Medical Devices (Exemptions) Order 2024 |
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The Medical Devices Authority (MDA) would like to inform that the Medical Devices (Exemptions) Order 2024 has been gazetted and has come into effect from 5 March 2024. This order is enacted by amending some provisions of the Medical Devices (Exemptions) Order 2016 which has been gazetted. Accordingly, this gazette of the Medical Devices (Exemptions) Order 2024 repeals the Medical Devices (Exemptions) Order 2016 [P.U. (A) 103/2016].
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China issues guideline to intensify crackdown on health care fraud |
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China on Friday issued a guideline on the handling of crime cases involving health insurance fraud in a bid to intensify its crackdown on such offenses, which have been on the rise in recent years. The guideline, jointly issued by the Supreme People's Court, the Supreme People's Procuratorate and the Ministry of Public Security, is expected to provide a detailed legal basis for punishing individuals committing health care fraud.
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The government will deploy 20 military doctors and 138 public health doctors to 20 hospitals for 4 weeks starting from the 11th to fill the medical gap caused by the departure of medical residents. Regarding the claim by a doctors' group that the expansion of nurses' work areas is illegal, he dismissed it as "absolutely not true."
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The number of people getting kidney failure here has gone up by 40 per cent over the past decade, with significantly more men and Malays suffering from it. Among patients starting dialysis in 2022, three in five were men, while proportionately, three times more Malays than Chinese suffered from kidney failure. For every one million Malays, 459 required dialysis in 2022, compared with 150 per million for Chinese, and 183 for the Indian population.
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Sooma launches system for remote clinician-monitored brain stimulation |
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Sooma is proud to announce the launch of its new system for the remote treatment of depression, Sooma Duo. Comprised of a medical device, a treatment management platform, and a patient application, the system brings remote monitoring and patient guidance to neuromodulation, enabling drug-free depression treatments to patients who cannot access traditional in-clinic services and thus promoting equal treatment access to all patients.
Learn more →
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myTomorrows Partners with The ALS Association to Support ALS Patients in Accessing Clinical Trials
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myTomorrows today announced a new partnership with the ALS Association, the U.S.-based nonprofit organization fighting ALS on every front. myTomorrows is a global health technology company shaping the future landscape of clinical trial accessibility with a platform that serves patients, physicians, trial sites and BioPharma, connecting each stakeholder at key points in the recruitment funnel in a seamless, supportive experience. Through the partnership, the ALS Association will tap into myTomorrows’ vast database of ongoing clinical trials and leverage its patient navigation service to ensure that treating physicians and those living with ALS are equipped with up-to-date information about appropriate pre-approval treatment options and ultimately guided towards relevant clinical trials.
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Modified MAGEC X system for early onset scoliosis treatment can now be used in the UK
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The modified MAGEC X system can now be appropriately selected for use in surgery for early onset scoliosis treatment in accordance with the manufacturer’s instructions for use. All previous generations of the MAGEC system (MAGEC 1,1.5, 2B) remain suspended in the UK and should not be implanted. Parents and carers of children who have been waiting for surgery during the period of the UK suspension of these devices, should discuss the options available to them with their medical team.
Learn more →
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Product Reached Customers |
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Population studies are medium-to-large scale studies that involve (in our industry) medical devices which are used to monitor, diagnose, analyse a specific population to serve as a driver or input to regional, national, or global healthcare initiatives or outcomes.
These are arguably the most challenging type of customers because of the involvement of the government, significant deployment, oftentimes using locally produced or easily available medical devices (including software) and therefore a challenge for a foreign manufacturer to be involved in such studies.
This is the true test of a device’s value proposition as it would need to be better, faster, cheaper in order to stand a chance against the state-of-the-art (which may turn out to be an antique method!) or locally made devices.
Other than the novel technology or workflow offered by your device, understanding the various stakeholder would matter very much. Healthcare services would need to be funded – where does this funding come from? Is it to the manufacturer, to the hospital, to the other healthcare facilities or for the patients?
Is the department you are in contact with the only department that is running the study? Or are there others similarly capable? What if this department drops the project, what is your plan B? How are you intending to get the product approved? Is it coming in as a trial product or a formally approved one? What is the business model? Purchase? Rental? Free? Is there a need, according to government policy, to have a health technology assessment performed?
Not every device has the potential to take part in a population study. Sometimes it may take a COMBINATION of devices involving several companies to come together for an integrated approach to the study, that would make things work. In short, as long as the country or region has an impetus to perform the study for the benefit of public health, it can get funded, and there’s no current solution that is able to match what you may be offering, it worth a go.
Access-2-Healthcare has, over the years, grown to develop an infrastructure of legal entities, human talent, and government networks, working together with a sizeable database of clients and contacts in the medical technology world. If you feel there’ may be a possibility to give this a go, let us know. |
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International Medical Device Regulators Forum |
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This year's IMDRF meeting, hosted by the US FDA, addressed key challenges in regulating medical devices. A central theme was achieving good reliance practices among regulatory authorities. This means leveraging the work done by other regulatory bodies while still maintaining control over individual decisions. This collaboration is an important step towards globally standardized regulations.
Discussions also highlighted the importance of: • Protecting patient safety within each jurisdiction • Enabling faster access to innovative medical technologies • Achieving the long-term goal of one-time global approval for medical devices
The IMDRF working groups are developing guidance documents to achieve these goals. Stakeholders can expect to see documents on harmonizing global marketing review requirements and device/risk characterization later in the year. |
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