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THAILAND:  Medical Device Registration Exemption Criteria, Methods and Conditions  prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

THAILAND: Medical Device Registration Exemption Criteria, Methods and Conditions prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

  • 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

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THAILAND: Prohibition of Manufacturing, Importation or Sale of Powdered Surgical Gloves

THAILAND: Prohibition of Manufacturing, Importation or Sale of Powdered Surgical Gloves

  • 2020-12-24 10:59:21

In the past Thai FDA had perpetually notified manufacturers / importer / distributors regarding the acute adverse effect of powdered surgical gloves to end-users or patients. Now, the Thai FDA has officially announced the prohibition of manufacturing, importation or sale of powdered surgical gloves, to ensure safety control to end-users or patients and prevention of adverse effect from the use of powdered surgical gloves.

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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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