Requirement of medical device application in Japan
Japan is the world's third-largest medical market due to the high coverage rate of its healthcare system and an aging population, which increases the demand for various medical devices. In recent years, the Japanese government has been gradually simplifying the review process to expedite approvals for medical products and has established a medical information database to improve information disclosure.
2023 Bio Asia-Show TALENT Dynamics
The largest annual biotechnology event in Asia - Bio Asia, came to a successful close on July 30th at the Taipei Nangang Exhibition Center. During the exhibition, the dedicated team from TALENT showcased our comprehensive range of services to clients, including pre-clinical testing, clinical operations, and post-market regulatory affairs. The team received a continuous stream of inquiries and consultations from industry professionals and company representatives. This Bio Asia exhibition provided a significant opportunity for TALENT to demonstrate our expertise in the CRO field and gain insights into the latest industry trends.
The biggest bio exhibition-Bio Asia 2023!
TALENT CRO Inc. will meet you at booth M927!
Bio Asia-Taiwan 2023 will be held July 27-30, in Taipei, Taiwan. This event is the biggest bio exhibition in Asia and it brings thousands professional visitors to attending.
This year TALENT will be exhibiting Bio Asia-Taiwan 2023 with our partner CCRC M in Nangang Exhibition center Hall 1.
Good Distribution Practice Regulations– Western Pharmaceuticals
TFDA has announced a draft for drug categories, matters, methods, and timelines in May 2023 base on the implementation of the Western Pharmaceuticals Good Distribution Practice (GDP).
Announcement of medical devices shall be indicated Unique Device Identifier.
In February 2023, TFDA established the Regulations for Medical Devices are required to place UDI on labeling or minimize package based on Article 33, of the Medical Device Act, and abolished Announcement No. 1101602479. The regulations require that UDI be displayed on the primary packaging or the device itself for class II and III medical devices. If the packaging or device is too small, the UDI should be marked on the smallest sales package.
How do manufacturers prepare for MDR?
Recently, the European Union passed the resolution about the extension transition period of MDR until 2027 or 2028. The new deadlines depend on the type and risk class of medical devices. The implementation of extension is due to many reasons, such as pandemic, long-term review time, much higher requirements of clinical data and evaluation. All of the above reasons cause the medical device with MDD certificate can’t meet MDR requirements on time then going off the market.
