• 2020-05-06 03:06:32

MDA has launched a new web-portal, replacing the old one and a new Feedback Management System (FEMES). These new web-portal and FEMES system have been introduced to provide better information delivery and take note of customer feedbacks more effectively.

• 2020-05-06 02:40:59

MDA is organizing the MyMEDEX exhibition for a second time and International Medical Device Conference 2019 from 15th to 17th October 2019, at the Malaysia International Trade & Exhibition Centre (MITEC).

• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-05 06:40:46

MDA has issued a new guidance document on how to bring in special-access devices for specific purposes into Malaysia. MDA defines special access medical device as medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.

• 2020-05-05 06:26:29

MDA has issued a draft guidance document for getting an exemption for export-only medical devices from registration requirement. This draft is open for public comment and the official document is expected to be released soon.

• 2020-02-12 14:07:31

In November, MDA had issued three major guidance documents, two of them being revised editions. One of these two is the 3rd revised edition of Guidance Document for Change Notification for Registered Medical Device in Malaysia.

• 2020-02-12 14:04:30

MDA has recently released a new guidance document regarding the requirements for application of Certificate of Free Sale (CFS) for export only medical devices. There had been plenty of queries received by MDA on the application of CFS for various applications and as a first step, they have released this GD, specifically for export only medical devices.

• 2020-02-12 14:25:26

At the end of September 2018, Medical Device Authority (MDA) had introduced two search engines/databases for the public-use. On a first glance, they look similar to the medical device database of Singapore HSA’s Singapore Medical Device Register (SMDR) but the working mechanism and output are different.

• 2020-02-12 15:07:55

The Medical Device Authority of Malaysia is pleased to announce that the 23rd AHWP Annual Meeting this year will be held at Malaysia International Trade & Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 22-25 October 2018.

• 2020-02-12 15:06:56

MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.