• 2020-02-15 06:21:59

In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.       

• 2020-02-15 06:18:22

On November 1st of 2017, the Medical Device Authority (MDA) released the Draft of a new Guidance Document on the Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education. This Guidance Document came just in time to answer foreign manufacturers and local distributors’ concerns on whether unregistered medical devices are allowed to be imported into Malaysia for non-commercial purposes, for a specified timeline.

• 2020-02-15 06:16:53

n order to ensure that the 3D printing production of medical equipment is scientific, safe and effective, and to uphold consumer protection, the Taiwanese Food and Drug Administration (TFDA) commissioned the national Cheng Kung University to develop a draft of "the product management guideline for 3D printing medical device,” which is applicable to medical devices which use 3D printing technology in their manufacturing process.

• 2020-02-15 06:30:30

HSA drafted Guidance 34 for IVD Analyzers, to address the concerns of product owners and registrants with IVD analyzers and their associated accessories. GN-34 is “intended to act as a ‘one-stop’ document for IVD analyzers”.