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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 29, 20252 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 25, 20252 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 23, 20252 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 16, 20252 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 9, 20253 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 8, 20253 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 2, 20253 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 1, 20252 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 26, 20252 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 24, 20252 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 18, 20252 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 16, 20252 min read


Switzerland: Swissmedic Revises Foreign Manufacturer GMP Requirements (w.e.f. 1 May 2025)
Swissmedic released an important amendment to its guidance document on Good Manufacturing Practice (GMP) compliance for foreign...

ARQon
Jun 11, 20252 min read


Singapore: Hello SHARE, Your Quick Guide to the Big Switch
The Health Sciences Authority (HSA) is ushering in a new era for the medical device industry with the launch of the Singapore Health...

ARQon
Jun 5, 20251 min read


Singapore: HSA Opens Consultation on AI-SaMD Regulatory Sandbox
The Health Sciences Authority (HSA) launched a public consultation on a pivotal proposal that could significantly reshape the landscape...

ARQon
Jun 4, 20252 min read


Singapore: HSA Adopts ICH E6 (R3) GCP Guidelines (w.e.f. 1 January 2026)
The landscape of clinical research is constantly evolving, and with it, the standards that ensure trial integrity and participant safety...

ARQon
May 28, 20252 min read


Malaysia: MDA Issues Advisory on Malaria Test Kit
The World Health Organization (WHO) released a notification regarding the performance of certain malaria diagnostic test kits , which has...

ARQon
May 27, 20251 min read


Vietnam: MOH Tightens Grip on Sunscreen Market
The Drug Administration of Vietnam has issued a significant directive to enhance the management and oversight of cosmetic products,...

ARQon
May 22, 20252 min read


Thailand: TFDA Activates New e-Certificate System (w.e.f. 1 May 2025)
Beginning 1 May 2025, in a significant move toward digital transformation, Thailand’s Food and Drug Administration (FDA) has officially...

ARQon
May 21, 20251 min read


India: New System Automates MSC and NCC Certificates Issuance for Medical Devices
To further enhance the ease of doing business and improve regulatory efficiency, the Central Licensing Authority has introduced a...

ARQon
May 15, 20251 min read
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