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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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HONGKONG: Continuance of trial to accept marketing approval  obtained from the National Medical Products Administration for listing application of medical devices  under the Medical Device Administrative Control System (MDACS) - March, 2020

HONGKONG: Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS) - March, 2020

  • 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

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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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