• 2022-08-30 03:36:34

The Malaysian Medical Device Authority (MDA) issued the Fifth Edition Guidance for Labeling on Registered Medical Devices. The document's goal is to provide manufacturers and authorized representatives with a guidance on the content of medical device labelling.

• 2022-02-18 09:44:59

On 9 December 2021, the Vietnamese government issued Decree No. 111/2021/ND-CP amending and supplementing a number of articles of Decree No. 43/2017/ND-CP on Goods Labels, including medical devices ("Decree 111"), which will take effect as of 15 February 2022.

• 2021-08-26 12:49:31

Thai FDA alerted Medical Device Establishment concerning labeling and device document implementation applicable for all 4 classifications; Licensed Medical Device (Class 4), Notified Medical Device (Class 3+2), and Listing (Class 1). This remarkable movement is aiming to ensure consumer safety while practicing device traceability during post-market surveillance.

• 2020-05-06 05:18:20

The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.

• 2020-02-12 14:01:43

In early November, CMDE has published a draft guideline for the reprocessing validation and labeling for reusable medical devices: Part 1 (hereinafter referred to as the "Guidelines") which solicited opinions from the public.

• 2020-02-14 07:54:36

On February 6, 2018, Medical Device Authority (MDA) of Malaysia released a Second Edition of the Guidance Document on Requirements for Labelling of Medical Devices. This GD serves a great purpose in informing the stakeholders on the additional requirements and content to be included in medical device labelling which are to be placed in Malaysia market or be exported.