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INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

  • 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

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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 MeDC@St 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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