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Blogs
Latest regulatory update


Malaysia: MDA, HSA, Forge Closer Ties with pilot Medical Device Regulatory Reliance Programme (1 Sept 2025 - 28 Feb 2026)
22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the...
12 hours ago


Singapore: HSA Tightens Therapeutic Product Registration (effective 30 July 2025)
As part of its ongoing efforts to streamline regulatory processes and ensure better clarity for applicants, the Health Sciences Authority...
5 days ago


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...
6 days ago


Hong Kong: "1+" Mechanism Guidance for Faster Approvals
Since 1 November 2023, Hong Kong has embraced the “1+ mechanism” , a progressive pathway for registering new drugs. Under this system,...
Aug 14


United Kingdom: MHRA Gains WHO-Listed Authority Recognition
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been officially designated as a WHO-Listed Authority (WLA) by...
Aug 13


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...
Aug 4


Malaysia: Mandatory Screening Package for New Drug and Biologic Registrations (effective from 16 June 2025
In a continued effort to strengthen the quality and efficiency of regulatory assessments, the National Pharmaceutical Regulatory Agency...
Jul 30


India: WHO-GMP COPP Now Mandatory via ONDLS Portal (effective from 15 August 2025)
In its ongoing efforts to streamline pharmaceutical regulatory procedures and embrace digital transformation, the Central Drugs Standard...
Jul 29


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,...
Jul 25


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...
Jul 23


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...
Jul 16


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...
Jul 9
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