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Indonesia: E-Catalogue V5 for Construction and Health Showcases Deactivated (effective 31 July 2025)
The National Public Procurement Agency of Indonesia (LKPP) officially announced the deactivation of Version 5 of the E-Catalogue for...

ARQon
Aug 262 min read


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...

ARQon
Aug 252 min read


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...

ARQon
Aug 202 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


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,...

ARQon
Aug 142 min read


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...

ARQon
Aug 132 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: 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...

ARQon
Jul 302 min read


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...

ARQon
Jul 292 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


Australia: New Australian Measures to Improve Medical Device Oversight
Australians who depend on medical devices will soon benefit from significant enhancements in the way device-related safety issues are...

ARQon
Jul 12 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


South Africa: SAHPRA Raises the Bar with ISO 13485 Certification and MDSAP Membership, Signals Regulatory Excellence
The South African Health Products Regulatory Authority (SAHPRA) has made significant strides in enhancing its regulatory framework for...

ARQon
Jun 242 min read


Malaysia: MDA Bans Online Sales of Optical Devices and Contact Lenses
The Medical Device Authority (MDA) has released an official statement reinforcing a strict prohibition on the online sale of optical...

ARQon
Jun 182 min read


China: NMPA Issues 6 New Cosmetic Ingredient Testing Methods (w.e.f. 1 July 2025)
The National Medical Products Administration (NMPA) has officially issued the updated Announcement No. 45 of 2024, introducing six...

ARQon
Jun 162 min read
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