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SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

  • 2024-06-20 05:41:18

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

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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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INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

  • 2024-01-26 06:28:31

Telecommunication technologies or devices in Indonesia, including telecommunication medical devices, should apply for Certificate of Telecommunication Device. In order to comply with this requirement at this moment, Indonesia MoH encourages manufacturer of medical devices with Bluetooth and RFID feature to voluntarily submit either Certificate of Telecommunication Device or Declaration Letter confirming the proposed product will apply for this certification during pre-market application.

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INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

  • 2023-10-20 07:21:15

In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.

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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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USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

  • 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

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