• 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

• 2021-09-29 00:25:11

In order to further standardize the generic names of medical devices and strengthen the management of the whole life cycle of medical devices, NMPA has organized and formulated six naming guidelines.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.

• 2021-04-26 02:48:33

In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.

• 2021-04-26 02:44:41

The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.

• 2020-12-24 11:09:03

Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.

• 2020-02-12 14:21:01

為了加強對醫療器械開發，生產，運營和使用的監督管理，NMPA（國家醫療產品管理局）於8月底發布了“ UDI醫療器械法規草案”，其主要目的是： 建立醫療設備的唯一識別系統（UDI）。 本法規適用於在中國銷售和使用的醫療設備。

• 2020-02-14 07:50:54

唯一設備標識（UDI）系統是一組字母數字代碼，用於增強醫療設備的監視活動。 它由兩部分組成：（1）UDI（一串字母數字代碼）和（2）UDI載體，分為三種不同類型：（a）QR碼，（b）條形碼或（c）RFID / NFC。