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Latest regulatory update


Singapore: HSA Updates GN-21, Now with Smarter Change Notifications for Medical Devices (effective from 14 July 2025)
The Health Sciences Authority (HSA) has announced the implementation of revised GN-21, which is set to take effect on 14 July 2025 . This...
5 days ago


United Kingdom: UK Enacts New Post-Market Surveillance Rules for Medical Devices (w.e.f. 16 June 2025)
As of 16 June 2025 , a significant new chapter begins for medical device regulation in Great Britain, marking the first major overhaul of...
6 days ago


Thailand: New TFDA Guidelines on Personal Medical Devices Importation
The Thai Food and Drug Administration (FDA) has implemented significant revisions to its medical device import policies through...
Jul 2


Australia: New Australian Measures to Improve Medical Device Oversight
Australians who depend on medical devices will soon benefit from significant enhancements in the way device-related safety issues are...
Jul 1


India: Streamlining Sterilization Outsourcing for Medical Device Manufacturers
The Medical Device Rules, 2017 (MDR-2017) have been instrumental in ensuring the quality and safety of medical devices in India. However,...
Jun 26


South Africa: SAHPRA Raises the Bar with ISO 13485 Certification and MDSAP Membership, Signals Regulatory Excellence
The South African Health Products Regulatory Authority (SAHPRA) has made significant strides in enhancing its regulatory framework for...
Jun 24


Malaysia: MDA Bans Online Sales of Optical Devices and Contact Lenses
The Medical Device Authority (MDA) has released an official statement reinforcing a strict prohibition on the online sale of optical...
Jun 18


China: NMPA Issues 6 New Cosmetic Ingredient Testing Methods (w.e.f. 1 July 2025)
The National Medical Products Administration (NMPA) has officially issued the updated Announcement No. 45 of 2024, introducing six...
Jun 16


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...
Jun 11


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...
Jun 5


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...
Jun 4


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...
May 28
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