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Blogs
Latest regulatory update

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...
3 days ago

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...
4 days ago

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...
Mar 19

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...
Mar 18

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...
Mar 12

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...
Mar 11

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...
Mar 4

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...
Mar 3

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...
Feb 26

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...
Feb 24

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...
Feb 19

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...
Feb 18
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