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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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HONG KONG:  MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

HONG KONG: MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

  • 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

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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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