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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
2 days ago2 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
3 days ago1 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

India: Extended Deadline for Small and Medium Pharma Manufacturers to Comply with Schedule M (w.e.f. 31 December 2025)
The Ministry of Health and Family Welfare has announced a proposed amendment to the Drugs Rule, 1945, extending the compliance timeline...
ARQon
Feb 112 min read

Singapore: Simplify CTGTP Licensing with SHARE (w.e.f. 10 February 2025)
The Health Sciences Authority (HSA) is excited to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System)...
ARQon
Feb 102 min read

Malaysia: Online Advertisement Applications Begin March 2025
The Medical Device Authority (MDA) is set to enhance its application process by transitioning to a fully online system for advertisement...
ARQon
Feb 61 min read

Australia: Transition from URPTG to PRAC (w.e.f. March 2025)
The Therapeutic Goods Administration (TGA) has announced significant updates to its recall process, slated for implementation in early...
ARQon
Feb 62 min read

Ireland: The Nordic Packaging Pilot and Joint Packs Initiative
The landscape of medicine packaging in Europe is evolving to address challenges related to medicine availability, particularly for...
ARQon
Jan 282 min read

Finland: EU F-Gas Regulation for HFC-Containing Inhalers (w.e.f. 1 January 2025)
Effectively from 1 January 2025 , new regulatory requirements have come into effect for placing inhalation sprays containing...
ARQon
Jan 222 min read

Vietnam: Medical Device Import License Extended to 30 June 2025
The Ministry of Health of Vietnam (MOH) recently issued Decree No. 04/2025/ND-CP, introducing amendments and supplements to Decree No....
ARQon
Jan 212 min read

Malaysia: NPRA’s New Protocol Assessment and Testing Procedure for Registered Vaccine Products
The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of...
ARQon
Jan 132 min read
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