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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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[ANALYSIS] MALAYSIA Market Overview and Importations of Medical Devices - October 2017

[ANALYSIS] MALAYSIA Market Overview and Importations of Medical Devices - October 2017

  • 2020-02-15 06:29:08

Malaysia’s healthcare system consists of two tiers: a state-owned universal healthcare system for national citizens runs alongside a private sector that serves international patients.  Due to projected demographic shifts – chiefly Malaysia’s ageing population, increasing life expectancy and the growth of non-communicable diseases – demand for medical device is expected to grow.

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 VIETNAM: Important Regulatory Update on Medical Device Registration - October 2017

VIETNAM: Important Regulatory Update on Medical Device Registration - October 2017

  • 2020-02-15 06:27:24

 Starting in 2017, all medical devices imported into Vietnam will be required to register for Marketing Authorization (MA) licenses. The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and began receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D.

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