Newsletter

Combating a Growing Threat: Japan's Rise in Cancer – Increasing Demand for Advanced Treatments – October/November 2024

Combating a Growing Threat: Japan's Rise in Cancer – Increasing Demand for Advanced Treatments – October/November 2024

  • 2024-11-05 02:28:52

Japan is grappling with a growing cancer crisis, which has become the leading cause of death and is expected to increase significantly in the coming decades due to an aging population. To address this, Japan has strengthened its healthcare system by designating hundreds of hospitals as cancer care centers. The rising healthcare burden creates opportunities for innovative medical technologies to improve cancer diagnosis and treatment. With a strong focus on technological advancement and openness to foreign innovation, Japan presents a promising market for medical device manufacturers, where expert regulatory guidance is essential for success.

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Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

  • 2024-10-10 08:23:53

The Thai Food and Drug Administration (FDA) has initiated a registration process for Mpox diagnostic test kits in response to rising concerns over the spread of the viral infection. This move aims to enhance early detection and management of Mpox cases, ensuring public health safety. The Thai FDA has streamlined the registration process for manufacturers and importers, focusing on quality and accuracy of the diagnostic kits. This initiative is a key step in Thailand's efforts to curb the spread of the virus and strengthen its response to emerging health threats.

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MALAYSIA: MDA advise Establishments to Submit Medical Device Re-Registration Applications One Prior to Certificate Expiration Date - July 2024

MALAYSIA: MDA advise Establishments to Submit Medical Device Re-Registration Applications One Prior to Certificate Expiration Date - July 2024

  • 2024-07-30 03:35:49

The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.

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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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MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.

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