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MALAYSIA: MDA REPEALS CIRCULAR EXEMPTING COVID-19 TEST KITS FROM THE COMPLIANCE ASSESSMENT PROCESS - APRIL/MAY 2024

MALAYSIA: MDA REPEALS CIRCULAR EXEMPTING COVID-19 TEST KITS FROM THE COMPLIANCE ASSESSMENT PROCESS - APRIL/MAY 2024

  • 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

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MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

  • 2023-09-27 06:46:28

The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).

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SINGAPORE: COVID-19 TEST KITS AUTHORIZED FOR PROFESSIONAL AND SELF-USE IN SINGAPORE — AUGUST/SEPTEMBER 2023

SINGAPORE: COVID-19 TEST KITS AUTHORIZED FOR PROFESSIONAL AND SELF-USE IN SINGAPORE — AUGUST/SEPTEMBER 2023

  • 2023-08-23 05:30:31

Effective July 1, 2023, COVID-19 diagnostic tests for professional use and self-test kits that were previously authorized under the Pandemic Special Access Route (PSAR) should now be registered through full-fledged product registration. In addition, validation requirement documents for each product type for professional use only and self-test kits were also issued by HSA.

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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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