• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

• 2023-01-19 06:04:35

The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

• 2022-12-27 08:57:20

The Center for Medical Device Evaluation (CMDE) has issued the “List of Mandatory Standards Applicable to Medical Devices” for applicants to determine the mandatory standards which apply to a specific product.

• 2022-12-27 07:34:59

With the implementation of SATUSEHAT (the Indonesia Health System), the MoH are starting to build a Pharmaceutical and Medical Device Dictionary that will contribute to the interoperability between digital health apps and supply chain information of drugs and medical devices.

• 2022-12-27 05:48:52

The Malaysia Medical Device Authority (MDA) released the latest 4th Edition Change Notification for Registered Medical Device, MDA/GD/0020. More substantial changes were made compared to the 3rd Edition. There are new additional clauses and updated documents requirements. The MDA revised the turn-around time for Category 2 and Category 3. Furthermore, some changes do not require a change notifications to be submitted to MDA.

• 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

• 2022-12-27 05:30:57

To promote an effective reviewing procedure, Thai FDA granted that therapeutic medical devices shall be classified and registered under Listing (Class 1 medical device), in effect from 3rd December 2022 onward.

• 2022-11-29 03:04:45

As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.