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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: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

  • 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

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 MALAYSIA: New Regulation Issued on Licensing and Medical Device Registration for Original Equipment Manufacturer (OEM) - April 2018

MALAYSIA: New Regulation Issued on Licensing and Medical Device Registration for Original Equipment Manufacturer (OEM) - April 2018

  • 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

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