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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 112 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 51 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 42 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 282 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 271 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 222 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 211 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 151 min read


China: New Quality Guidelines for Online Medical Devices Sales (w.e.f 1 October 2025)
With the exponential rise of e-commerce in healthcare, China is taking significant steps to safeguard patient and product integrity...

ARQon
May 82 min read


Malaysia: MDA Implements Medical Device Import Permit Requirement (transition w.e.f 14 April 2025)
In a move to enhance the regulation and traceability of medical device imports, the Medical Device Authority (MDA) has officially...

ARQon
May 52 min read


Australia: Transitions to Sole Ingredient Names on Medicine Labels (w.e.f 1 May 2025)
Starting 1 May 2025 , medicine labels in Australia will begin to phase out dual ingredient names and move towards using only the updated...

ARQon
Apr 302 min read


Singapore: HSA's SHARE System Launch (July 2025) and Introductory Briefing Session (9 May 2025)
The Health Sciences Authority (HSA) is set to roll out a significant update to its regulatory infrastructure with the Singapore Health...

ARQon
Apr 291 min read


United Kingdom: MHRA Launches Landmark Clinical Trials Reform (w.e.f 11 April 2025)
New legislation signed into law by the Medicines and Healthcare products Regulatory Agency (MHRA) on 11 April 2025 marks the start of a...

ARQon
Apr 242 min read


Pakistan: DRAP-PSW Gateway Goes Live for Online Pharmaceutical Export Certificate Applications (w.e.f 1 May 2025)
On the 17th of April 2025, the Drug Regulatory Authority of Pakistan (DRAP) released an update announcing a significant development in...

ARQon
Apr 232 min read


Malaysia: MDA Sets 2-Year Validity Period for Product Classification Letters (w.e.f 1 May 2025)
The Medical Device Authority (MDA) has announced a key regulatory update that impacts all stakeholders within the medical device and...

ARQon
Apr 171 min read


Malaysia: Transition to Online Product Classification Application Process by MDA (w.e.f. 1 May 2025)
Starting 1 May 2025 , the Medical Device Authority (MDA) is pleased to announce that all product classification applications must be...

ARQon
Apr 141 min read


Global: IMDRF Seeks Industry Input on Draft Regulatory Reliance Programs Playbook
The International Medical Device Regulators Forum (IMDRF) has opened a critical consultation period for its Playbook for Medical Device...

ARQon
Apr 72 min read


India: CDSCO Simplifies Schedule M Compliance Extension Process via ONDLS Portal (w.e.f. 25 March 2025)
The Department of Health and Family Welfare has taken a crucial step to support small and medium pharmaceutical manufacturers by granting...

ARQon
Apr 11 min read


China: Regulatory Adjustments for Imported Medical Devices in China
The recent adjustment to the “Announcement of the State Drug Administration on Matters Related to the Production of Imported Medical...

ARQon
Mar 262 min read


New Zealand: Demystifying Protocol Clarification Letters in Clinical Trials (w.e.f. 12 March 2025)
The Good Regulatory Practise for New Zealand (GRTPNZ) guidelines for clinical trials state that any modifications to a trial protocol...

ARQon
Mar 251 min read
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