• 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.

• 2020-02-12 15:05:51

In July 2018, Medical Device Authority (MDA) had issued Circular Letter No.4 Year 2018. This was pertaining medical devices manufactured or imported into Malaysia for eventual exportation purposes only. According to Section 5(1) of Medical Devices Act 2012 (Act 737),

• 2020-02-12 15:04:32

In Medical Device Act 2012 (Act 737) of Malaysia, there is no specific provision for medical devices imported/exported from/to countries without diplomatic ties with Malaysia, such as Israel. Malaysia has not acknowledged Israel as an independent sovereign state.

• 2020-02-12 15:03:41

In Malaysia, medical devices procurement by local healthcare institutions are heavily controlled in order to make sure the supplied medical devices are safe and efficient. For starters, there are many procurement methods, depending on the product’s market value.

• 2020-02-12 15:02:33

Aligned with these improvements is the development of a module on FDA Payment Portal that caters for all RRD clients of the Center for Device Regulation, Radiation Health and Research (CDRRHR). All manually assessed Orders of Payment (OP) are now integrated into this new payment collection system.

• 2020-02-12 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.

• 2020-02-12 15:00:06

Slight revision on guidance documents about Singapore Standards and Medical devices for exhibition were added last July 2018.

• 2020-02-12 14:58:58

In order to unify the management of medical device import license, MoH informed and stopped receiving the contents of request for adjustment of import license which has a validity period until Dec 31st, 2017 granted in accordance to Circular No. 30/2015/TT-BYT.

• 2020-02-12 14:56:43

This month’s updates include the "Medical Devices Procurement for Healthcare Institutions ", “Announcement Regarding Registration Application of Medical Devices and Licensed Establishment”, “Exemption from Registration Requirement for Export Only Medical Device” among others. All information you need to know have been summed up in a nutshell.