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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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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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SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

  • 2023-12-26 02:27:39

Following the industrial consultation earlier this year, Cyber Security Agency (CSA) of Singapore is launching Sandbox as a voluntary trial program for Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)). This program started on 20th October 2023 and will be held for 9 months. CSA is inviting medical device manufacturers to participate in Sandbox to have a first-mover advantage in enhancing the security of their products.

The Sandbox allows all parties involved to test out and give feedback on the requirements and application process for the CLS(MD) ahead of the scheme’s launch. Along with the launch of Sandbox program, CSA also published intensive set of regulations related to the requirements and implementation of CLS(MD).

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