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MALAYSIA:  Update of Conditions of Conditional Approval Letter – May, 2022

MALAYSIA: Update of Conditions of Conditional Approval Letter – May, 2022

  • 2022-05-26 13:54:50

The Malaysian Medical Devices Authority (MDA) has decided to replace the requirement for lot-to-lot variation testing for the approval of new lots of COVID-19 test kits with the requirement under the establishment's post-market duties and obligations. With these, the establishment need to notify MDA of any new lot of the test kit that will be placed in the market.

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MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

  • 2021-12-27 06:04:00

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

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MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

  • 2021-11-24 10:12:53

In collaboration with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP), the controls for the expansion of self-test kit sales will be implemented. The Covid-19 self-test kit can only be purchased from licensed community pharmacies and authorized health facilities.

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MALAYSIA: MDA Now Allows Multiple Authorised Representatives for A Brand Name – October, 2021

MALAYSIA: MDA Now Allows Multiple Authorised Representatives for A Brand Name – October, 2021

  • 2021-10-27 07:06:19

Effective from June 17, 2021, MDA now allows multiple authorized representatives for each medical device (brand name) placed in the market. On the other hand, they will restrict to requiring individual establishment licenses to carry out role/activity of various economic operators, as prescribed in the Medical Device Regulations 2012.

MDA Circular Letter No. 1/2014 contains two components, which are the establishment that acts as an authorized representative (AR) and the establishment that carries out various activities.

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