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Dear Valued Readers,
If you didn't have the best start of the year, for Asia we get another chance! With all of the festivities rounding up and getting back to the working mindset, Access-2-Healthcare are here to jumpstart with a series of recent industry, country and regulatory updated. We're committed to keeping you informed and empowered to navigate the evolving landscape with confidence.
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Malaysia MDA Publishes Harmonized Guidance on Post-Market Surveillance Information Exchange for ASEAN Member States
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Guidance - MDCG endorsed documents and other guidance |
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The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”.
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Thai FDA and PMDA, Japan enhances bilateral cooperation in pharmaceutical and medical device regulation |
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Food and Drug Administration (FDA), Thailand and Pharmaceutical and Medical De-vice Agency (PMDA), Japan recently convened for a bilateral meeting, aiming to en-hance regulatory systems for pharmaceuticals and medical devices. This collaboration aspires to ensure that citizens have access pharmaceuticals which are high-quality, effective and safe and recognized internationally, as well as to facilitate Thai-land’s access to innovative medical devices.
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PM says: “Increasing the number of medical schools is an essential task as a starting point for medical reform.” |
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On the 13th, Prime Minister Han Deok-soo repeatedly requested cooperation from the medical community regarding the government's plan to increase the number of medical school students, saying, "It is not the result of short-sightedness to place all the burden on doctors." He emphasized the policy of ‘stern response’ in relation to the possibility of collective action.
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The Department of Health (DOH) and the World Health Organization (WHO) have launched the 2024-2028 National Integrated Cancer Control Program (NICCP) Stra-tegic Framework.
The launch coincided with the commemoration of the 5th anniversary of the National Integrated Cancer Control Act (NICCA).
“Universal health coverage and strong primary health care are the keys to address-ing broader health system factors that influence equitable access to affordable and high-quality cancer care,” WHO Representative to the Philippines Dr. Rui Paulo de Jesus said in a joint press release on Wednesday.
“The WHO will continue to support the country in ensuring that the cancer control program is built on an effective health system,” he added.
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SENSOME announces intiation of clinical trial assessing its tissue microsen-sor technology in peripheral artery disease |
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Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today enrollment of the first pa-tients into a feasibility clinical study using the Clotild® Smart Guidewire in peripheral artery disease (PAD). Clotild® was designated a breakthrough medical device for use in brain arteries by the FDA in 2021.
The clinical trial, named SEPARATE, is designed to assess the Clotild® sensor's ca-pability to detect various characteristics of blood vessel blockages in PAD patients. The first 5 patients have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium. Preliminary results are anticipated in mid-2024.
Learn more →
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UNSW receives $20m to support medical breakthroughs
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Academics from UNSW Sydney have been awarded funding to support 10 research projects.
UNSW Sydney has been awarded over $20 million in the latest round of Medical Re-search Future Fund (MRFF) funding, including projects to investigate chronic pain management, preventing self-harm in children and adolescents, and managing knee replacement pain.
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Finding Distribution Channels |
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Making your end customers successful |
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One of the key things about distribution is the ability to understand your ecosystem
Let us break it down to the constituent parts
Payers – who is paying. Any reimbursement or insurance coverage? If not, then what are the other methods? Will the hospital, clinic or clinician make money as a result of using your device?
Service – if applicable, who will be servicing the device(s), or be the contact person for any complaints?
Storage and inventory – not just at the distributor’s end but at the customers’ end. How is the device impacting the storage and inventory of the end customer?
Learning about these constituent parts would help your end customer enable your device to be successful.
Hang on…No product-market-fit? No customer acceptance?
No, because this was already determined at the go-to-market level where the country and its product-market fit had already been confirmed. If you had not done so, then it’s one big step missed! Therefore, when you make your customers successful by thinking a step ahead of them, they will in turn make your successful.
In the meantime, we are in the midst of embarking on such a journey with a client, where we have identified these factors to enable true market access for the devices. Contact us to learn more. |
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From 29 January – 1 February 2024 |
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Middel East's largest healthcare exhibition returns to Dubai in its 49th edition this year, at the Dubai World Trade Centre, with well over 3,400 exhibitors, and over 110,000 healthcare professional visits expected, over 40 international pavilions, and more than 180 countries participating.
Arab Health has officially partnered with the Dubai Health Authority this year for the Public Health Conference from 29-30 January at the DWTC, under the theme, ‘Uniting for enhanced local and global public health’. Visitors have the opportunity to network, discover cutting-edge healthcare technology and game-changing healthcare insights, and form meaningful business connections at the exhibition.
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