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Latest regulatory update


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...
5 hours ago


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...
6 days ago


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...
Apr 14


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...
Apr 7


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...
Apr 1


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...
Mar 26


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...
Mar 25


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
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