• 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.

• 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

• 2021-08-26 11:37:06

Following extensive consultation, China's Center for Medical Device Evaluation (CMDE) has issued guidelines for artificial intelligence medical software product classification and definition.

• 2021-08-02 06:16:13

Thai FDA progressively issues series of guidelines to enhance the new medical device act. This month will be focusing on the latest requirement on medical device manufacturing, importation, and distribution records or report preparation.

• 2021-03-22 02:30:57

Health Sciences Authority (HSA) released a draft guideline for 3D Printed Medical Devices. This announcement is to clarify current regulatory requirements for 3D printed medical devices and to hear comments from stakeholders. The consultation period for this document will be from January 25, 2021, to February 28, 2021.

• 2020-12-23 01:29:16

Certificate of Medical Device Notification (CMDN) is now required to process the customs release of PPEs in addition to the LTO of the importer.

• 2020-09-15 09:16:21

PFDA released updated new normal guidelines in relation to PFDA transactions during the quarantine period. These documents will repeal the previously released FDA Circular No. 2020-006 and its amendments.

• 2020-02-21 07:26:10

PFDA released FDA Circular No. 2020-001 as initial implementation of Administrative Order No. 2018-0002 (Guidelines Governing the issuance of an authorization for a medical device based on ASEAN Harmonized Technical Requirements).

• 2020-02-21 07:11:04

On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " . The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances.

• 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.