Asia
The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.
Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?
In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.
The revival in funding of healthtech and pharma startups was significantly influenced by PharmEasy's $216m funding round, led by the Manipal Education and Medical Group (MEMG), albeit at a reduced valuation of $710m—a sharp decline from its previous $5.6bn valuation in 2021.
The Union Budget 2025 has overlooked several critical aspects that the medical devices and in-vitro diagnostics (IVD) sector had been expecting, industry leaders have pointed out.
With increased government focus on self-reliance and digital healthcare, 2025 will be a pivotal year for the sector. From startups to established players, all eyes are on the breakthroughs that will define the future of medtech in India.
Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.
Indian startups hold significant potential to address the gap created by the ban on import of refurbished medical products, but they face challenges on several fronts and call for more government support.
Healthcare experts believe that India’s ban on imports of refurbished medical devices has left a vacuum and if an implementable policy is not introduced soon, it could prove disastrous for healthcare providers and patients.
The head of the Korea Regulatory Science Center discusses why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.
The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
Vitestro's automated blood drawing robot received CE marking on August 28. The company is limiting release of the robot over the next 12 months to a small number of selected hospitals, with plans to scale up production thereafter.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.
The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.
Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.
Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.