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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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MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

  • 2021-05-22 05:17:57

In April 2021, Medical Device Authority (MDA) published new guidelines for the implementation of a medical device regulator system which is listed the requirements for application for medical device advertisement approval. The guidelines are to helps the establishment to comply with the regulations Act 737. These guidelines shall be read together with Guidance Documents of Code of Advertisement (COA).

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