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
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Taiwan’s long-anticipated new law regulating medical devices modifies the way devices are classified, mandating they be grouped by product category and risk, adjusts device registration fees, and mandates adherence to certain technical guidelines for preparing documents related to device registration applications. The... Read More
Low insurance reimbursement rates in Taiwan are discouraging the development of innovative pharmaceutical products, according to a study by Fitch Solutions. Because essential healthcare for all residents of the island nation is covered by a single public system, and hospitals negotiate with... Read More
Medical device manufacturers will be required to include unique identification (UDI) codes on the labels of their products sold in Taiwan beginning May 1, under new medical device regulations established by the government. The requirements, released in draft form in January and... Read More