• 2020-02-14 07:48:41

The Medical Device Authority (MDA) of Malaysia has organised for a medical device exhibition to be held in Malaysia in April 2018. This event, the Malaysia Medical Device Expo, is an initiative by MDA to bring light to latest innovative technologies and advances of global medical devices, in hopes to provide all its stakeholders a one-stop centre for medical devices solutions.

• 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.

• 2020-02-14 14:53:03

Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives.

• 2020-02-14 14:52:01

Starting from January 1, 2018, the Malaysian Communications and Multimedia Commission (MCMC) no longer permits any kind of Short Range Devices (SRD) and Radio Frequency Identification Devices (RFID) to operate in the frequency range from 869 MHz to 870 MHz.

• 2020-02-15 06:20:38

A new Circular Letter was released by Medical Device Authority (MDA) on October 2, 2017, in which MDA recognizes Institute of Medical Research (IMR) Malaysia as a credible source to provide clinical evaluation data for conformity assessment purposes conducted by a Conformity Assessment Bodies (CAB) in Malaysia. This Circular Letter comes into effect starting October 2, 2017.

• 2020-02-15 06:19:28

The Medical Device Authority (MDA) is inviting all its customers to participate in a Customer Satisfaction Survey. MDA is always trying to improve quality of service provided to all its customers.

• 2020-02-15 06:18:22

On November 1st of 2017, the Medical Device Authority (MDA) released the Draft of a new Guidance Document on the Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education. This Guidance Document came just in time to answer foreign manufacturers and local distributors’ concerns on whether unregistered medical devices are allowed to be imported into Malaysia for non-commercial purposes, for a specified timeline.

• 2020-02-15 06:17:38

On October 9, 2017, Medical Device Authority (MDA) Malaysia released a Second Edition of the Guidance Document on Change Notification for Registered Medical Device. This GD serves a great purpose in informing the stakeholders on the categories of changes, notification process and relevant requirements for applying for a change notification in Malaysia.

• 2020-02-14 15:25:25

On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device.

• 2020-02-15 06:29:49

  Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on Conformity Assessment for Medical Device that are yet to be registered.