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MALAYSIA: MDA Announced New Requirements to Register Medical Face Mask and Respirator

MALAYSIA: MDA Announced New Requirements to Register Medical Face Mask and Respirator

  • 2021-02-22 01:43:21

Masks and respirators, in various denominations. have become essential things in the new norm of life. There are many types of masks and respirators available in the Malaysian market. Thus, Malaysia Device Authority (MDA) published a new guidance document as a reference for stakeholders. This guidance explains of the type of face masks and respirators that are regulated under the Medical Device Regulations 2012 and the pre-requisites they need to fulfil.

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MALAYSIA: MDA revised guideline on how to apply for medical device registration under medical device act 2012 (Act 737) – May, 2019

MALAYSIA: MDA revised guideline on how to apply for medical device registration under medical device act 2012 (Act 737) – May, 2019

  • 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from [email protected] system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

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 MALAYSIA: New Search Engines Introduced by MDA - October 2018

MALAYSIA: New Search Engines Introduced by MDA - October 2018

  • 2020-02-12 14:25:26

At the end of September 2018, Medical Device Authority (MDA) had introduced two search engines/databases for the public-use. On a first glance, they look similar to the medical device database of Singapore HSA’s Singapore Medical Device Register (SMDR) but the working mechanism and output are different.

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