• 2024-03-01 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices

• 2023-08-23 05:47:28

The Medical Device Authority (MDA) arranged a conference where they made announcements on the implementation of the BayarNow system, creating an E-Certificate, speeding up the registration system, and establishing a relationship with MITI to help the industry.

• 2022-08-30 02:54:29

The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".

• 2022-06-29 01:41:00

The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).

• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2020-04-14 08:54:35

Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.

• 2020-02-21 06:51:47

On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.

• 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

• 2020-02-14 07:32:02

The new medical device rule “MDR 2017, India” has come into effect from January 2018. In line with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance documents,