• 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.

• 2022-12-27 03:31:34

An official letter number 6698/BYT-TB-CT was released on November 21, 2022, by the Vietnam Ministry of Health, collecting comments for a draft decree amendment of decree 98/2021/ND-CP

• 2022-11-29 03:32:40

Qualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.

• 2022-11-29 03:29:05

NMPA held a meeting to promote the implementation of the GB 9706 series standards on October 13th, 2022.

• 2022-11-29 03:18:42

NMPA supervised the product quality for various devices and found that a number of products did not comply with the requirements.

• 2022-11-29 03:08:35

The document sets out frequently asked questions and their answers regarding the implementation of the rules on clinical trials.

• 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.

• 2022-11-29 02:56:30

Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.

• 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.