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 MALAYSIA: Halal Certification for Medical Devices - March 2018

MALAYSIA: Halal Certification for Medical Devices - March 2018

  • 2020-02-14 07:49:21

This major announcement was made by the Department’s Halal Hub Division director, Datuk Sirajuddin Suhaimee in early February 2018, who said the certification, drafted together with the Department of Standards Malaysia, was now at the final stage of public feedback.

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MALAYSIA: Medical Device Expo Organised by MDA - March 2018

MALAYSIA: Medical Device Expo Organised by MDA - March 2018

  • 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.

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 MALAYSIA: Circular Letter Recognizing IMR Malaysia As A Credible Source To Provide Clinical Evaluation Data for Clinical Trials Conducted in Malaysia - November 2017

MALAYSIA: Circular Letter Recognizing IMR Malaysia As A Credible Source To Provide Clinical Evaluation Data for Clinical Trials Conducted in Malaysia - November 2017

  • 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.

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 MALAYSIA: [DRAFT] Guidance Document on Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education - November 2017

MALAYSIA: [DRAFT] Guidance Document on Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education - November 2017

  • 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.

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