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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
6 minutes ago2 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
24 hours ago1 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
6 days ago2 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


Malaysia: MDA Releases First Edition Guidance on Importation of Medical Device for Re-Export (IRE)
To provide clarity and streamline compliance with the Medical Device Act 2012 (Act 737), on the 13 March 2025, the Medical Device...

ARQon
Mar 192 min read


Singapore: HSA Calls for Stakeholder Feedback on Best Practice Guide for Medical Device Cybersecurity
The increasing integration of technology in healthcare has revolutionized patient care and introduced new cybersecurity challenges. As...

ARQon
Mar 182 min read


China: Enhanced Regulations for Cosmetic Ingredients Innovation
Effective on the issuance date, 26 January 2025, the National Medical Products Administration (NMPA) has started implementing “Several...

ARQon
Mar 123 min read


Indonesia: New KFA Registration Guide for Medical Device License Holders
The Indonesian Ministry of Health has announced crucial updates regarding the registration of medical devices in the Kamus Farmasi dan...

ARQon
Mar 112 min read


France: Secure Prescription Rules for Tramadol & Codeine (w.e.f. 1 March 2025)
The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced new regulations regarding the...

ARQon
Mar 42 min read


Ireland: HPRA Updates the Certificate of Free Sale Process
Staying compliant with regulatory requirements is crucial for medical device manufacturers and distributors. To support this, the Health...

ARQon
Mar 31 min read


Saudi Arabia: SFDA Introduces New Permit Service for Travellers Carrying Controlled Drugs
The Saudi Food and Drug Authority (SFDA) has launched a new service aimed at streamlining the process for travelers carrying controlled...

ARQon
Feb 262 min read


China: New Wire Assembly Standards (w.e.f. 1 October 2025)
The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire...

ARQon
Feb 242 min read


India: CDSCO Introduces New Online Module for Additional Cosmetic Variants
The Central Drugs Standard Control Organization (CDSCO) continues its effort to enhance efficiency and transparency in regulatory...

ARQon
Feb 192 min read


U.K.: MHRA's New Framework for Digital Mental Health Technologies
The Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance to help manufacturers navigate the UK medical device...

ARQon
Feb 182 min read
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