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Thailand: Thai FDA Streamlines Medical Device License Renewals (effective from 22 July 2025)
The Thai Food and Drug Administration (FDA) recently announced new regulations to streamline the process of renewing licenses for medical...

ARQon
2 days ago2 min read


China: New Standards for Medical Devices License and Filing Data Management
On 28 July 2025, the National Medical Products Administration (NMPA) officially issued two new information standards that will come into...

ARQon
Aug 192 min read


Malaysia: Malaysia-China Medical Device Regulatory Reliance Programme Launches Pilot Phase 1 (30 July 2025 - 30 September 2025)
In a landmark move for international medical device regulation, the Medical Device Authority (MDA) and National Medical Products...

ARQon
Aug 42 min read


Malaysia: Globally Leads with New Medical Device Regulatory Reliance Programme (effective from 30 July 2025)
In a world where healthcare innovation often outpaces regulations, one country is stepping forward to bridge that gap with confidence,...

ARQon
Jul 252 min read


Singapore: HSA Releases Updated SaMD and CDSS Guidelines (effective from 21 July 2025)
As the digital health landscape continues to evolve rapidly, the Health Sciences Authority (HSA) released the Revision 2 (R2) of its...

ARQon
Jul 232 min read


Hong Kong: DH Sets Timeline for CMPR and Primary Evaluation Framework
In a strategic move to become a global hub for healthcare innovation, the Department of Health (DH) has announced a detailed timetable...

ARQon
Jul 162 min read


Singapore: HSA Updates GN-21, Now with Smarter Change Notifications for Medical Devices (effective from 14 July 2025)
The Health Sciences Authority (HSA) has announced the implementation of revised GN-21, which is set to take effect on 14 July 2025 . This...

ARQon
Jul 93 min read


United Kingdom: UK Enacts New Post-Market Surveillance Rules for Medical Devices (w.e.f. 16 June 2025)
As of 16 June 2025 , a significant new chapter begins for medical device regulation in Great Britain, marking the first major overhaul of...

ARQon
Jul 83 min read


Thailand: New TFDA Guidelines on Personal Medical Devices Importation
The Thai Food and Drug Administration (FDA) has implemented significant revisions to its medical device import policies through...

ARQon
Jul 23 min read


India: Streamlining Sterilization Outsourcing for Medical Device Manufacturers
The Medical Device Rules, 2017 (MDR-2017) have been instrumental in ensuring the quality and safety of medical devices in India. However,...

ARQon
Jun 262 min read
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