• 2025-07-10 10:12:51

Malaysia Medical Device Authority (MDA) has announced that the re-registration function will be made available in the upgraded MeDC@St 2.0+ system exactly one year before the expiration date of the registration certificate. The implementation helps establishment in better planning and managing device re-registration and change notification in advance.

• 2025-05-06 08:38:10

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• 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.

• 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.

• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 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.

• 2024-06-20 06:05:56

Centre for Medical Device Evaluation, NMAP (CMDE) has made an announcement, on adjusting the management of digital certificate (CA certificates), aiming to fulfil the needs of current certificates management.

• 2024-03-01 08:59:50

The CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.

• 2023-11-20 01:38:47

The Medical Device Authority (MDA) announced on November 28th that the implementation of a fully electronic medical device registration certificate will start on November 1, 2023. MDA will only issue an electronic registration certificate for applications approved after November 1, 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.