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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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THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

  • 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

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HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

  • 2024-04-08 07:44:40

Last February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.

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INDONESIA: TRANSITIONING OF DISTRIBUTION LICENSE, FROM IPAK TO IDAK– MARCH/APRIL 2024

INDONESIA: TRANSITIONING OF DISTRIBUTION LICENSE, FROM IPAK TO IDAK– MARCH/APRIL 2024

  • 2024-04-03 09:56:03

On January 23, 2024, Indonesia's Ministry of Health has published an announcement emphasizing the compliance with the latest regulations for medical device distributors. Existing IPAK (Izin Penyalur Alat Kesehatan) holders need to transition to IDAK (Izin Distributor Alat Kesehatan) as the updated Medical Device Distributor License through the Online Single Submission (OSS) website.

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