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QT Promotion: Streamlining Medical Device Registration and Compliance in China with Qualtech – December/January 2025

QT Promotion: Streamlining Medical Device Registration and Compliance in China with Qualtech – December/January 2025

  • 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

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Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

  • 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

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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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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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