• 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 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.

• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.

• 2020-02-13 06:02:01

Medical Device Authority (MDA) is constantly trying to enhance the quality of service provided to all its customers. In line with this, MDA is currently conducting a customer satisfaction survey where all kinds of feedback are welcomed to help MDA constantly improve its output in the future.

• 2020-02-13 05:57:27

The Medical Device Authority (MDA) has been set on stricter implementing and enforcing the Medical Device Act 2012 (Act 737) via the gradual introduction of various policies. In 2016, it issued a policy providing a transition period of two (2) years for all local and foreign manufacturers importing,

• 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

• 2020-02-13 06:22:55

The number of registered medical devices which become obsolete and get discontinued and become orphaned are increasing in Malaysia with no policy in place to control them to meet requirements in accordance with the purposes of this Act.