According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
Contact us today for a free consultation with a Taiwan regulatory affairs consultant to discuss your specific needs. History and Overview The Taiwan Food and Drug Administration (TFDA) was established on January 1, 2010. The establishment of the TFDA followed the enactment... Read More
While telemedicine is now common in the West, it is also now growing in Asia. Some Asian countries recently outlined new telemedicine regulations. For example, Taiwan’s MOH recently announced draft amendments to their initial telemedicine regulation of 2018. Originally, telemedicine was to... Read More
While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will... Read More
On February 14, the Taiwan FDA (TFDA) promulgated new regulations for Class 2 and Class 3 medical devices. For these devices, a UDI code needs to be stamped on the outer frame of every packed medical device. For very small devices, the... Read More
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more. Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
In an effort to accelerate the medical device registration process, the Taiwan Food and Drug Administration (TFDA) has launched in January the TFDA Medical Device Pre-Market E-Submission System, which enables manufacturers to submit documents for their pre-market applications and renew licenses digitally. The new online... Read More
Contact us today for a free consultation with an Asia regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. 3-D printing has revolutionized product customization and digital manufacturing in various industries. In many instances, it... Read More