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.
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.
The new policy set by TFDA-Medical device management act
Due to the diversified development and types of medical device in recent years, it is gradually different from the drug management model. And the risk level of medical device is determined according to the classification and grading management.
Obligation on icons and symbols to display for manufacturers of medical devices
EN ISO 15223-1:2021 has been updated and replace ISO 15223-1:2016 with the aim to improve definitions and descriptions through new symbols for comply with various regulatory requirements.
