China is making additions to its medtech regulatory system, and Southeast Asian nations are making progress towards ratifying the regional Medical Device Directive. Meanwhile, cybersecurity, priority reviews and the Medical Device Single Audit Program are demanding attention regionally and globally, as ARQon consultant May Ng and Asia Regulatory Professional Association (ARPA) secretary Jack Wong report in this Asian regulatory update.
[Editor's note: This is the latest entry in Medtech Insight's regularly occurring Asia Reg Roundup, spotlighting important regulatory developments in Asia with the help of local experts.]
Cybersecurity was a major topic of discussion in health-care circles last month, when it became known that one of the...
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A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.
An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
