While China’s medical device market is still growing in double digits, several factors have made it harder for foreign companies to succeed there. China wants to make more of its own devices and export them to the rest of the world. The... 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
Recently, the President of Indonesia announced presidential regulation #6 requiring all drugs, biologics, and medical devices to meet Halal law. This law came into effect in mid-January. Medical products that do not have non-Halal components/materials and are made via a Halal manufacturing... Read More
In March 2021, the NMPA promulgated a regulatory notice on device master files. On January 18, 2023, they issued another notice titled – Further Clarity on the Registration and Use of Medical Device Master Files. Device Master Files are used to protect... Read More
For medical device registration in China, after a dossier is reviewed by the CMDE, additional information is almost always requested during the supplemental submission phase. Requested information can include things like additional supporting documents, more technical information, corrections of translations, etc. In January 2020,... 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
By March 3, 2023, Singapore’s HSA has requested industry comments on proposed medical device labeling for cybersecurity. The draft cybersecurity labeling scheme for medical devices (CLSMD) was initiated in late 2022 by the HSA, MOH, and Integrated Health Information Systems. Today, more... 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
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. While the China device market is huge and growing very quickly, once your device is approved there, market access can be very challenging. The... Read More