• 2025-10-27 04:30:17

List of selected frequently asked questions regarding the renewal of the medical device approval certificates. Originally in Thai, this English version offers practical guidance for maintaining compliance with Thai FDA requirements.

• 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

• 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

Stay ahead in China's evolving medical device regulations! Join our FREE webinar to master NMPA registration, technical reviews, and post-market compliance. Gain expert strategies to accelerate approvals and avoid risks—whether entering the market or optimizing compliance. Secure your spot now!

• 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.