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Blogs
Latest regulatory update


Malaysia: Malaysia-China Medical Device Regulatory Reliance Programme Launches Pilot Phase 1 (30 July 2025 - 30 September 2025)
In a landmark move for international medical device regulation, the Medical Device Authority (MDA) and National Medical Products...
Aug 4


Malaysia: Mandatory Screening Package for New Drug and Biologic Registrations (effective from 16 June 2025
In a continued effort to strengthen the quality and efficiency of regulatory assessments, the National Pharmaceutical Regulatory Agency...
Jul 30


India: WHO-GMP COPP Now Mandatory via ONDLS Portal (effective from 15 August 2025)
In its ongoing efforts to streamline pharmaceutical regulatory procedures and embrace digital transformation, the Central Drugs Standard...
Jul 29


Malaysia: Globally Leads with New Medical Device Regulatory Reliance Programme (effective from 30 July 2025)
In a world where healthcare innovation often outpaces regulations, one country is stepping forward to bridge that gap with confidence,...
Jul 25


Singapore: HSA Releases Updated SaMD and CDSS Guidelines (effective from 21 July 2025)
As the digital health landscape continues to evolve rapidly, the Health Sciences Authority (HSA) released the Revision 2 (R2) of its...
Jul 23


Hong Kong: DH Sets Timeline for CMPR and Primary Evaluation Framework
In a strategic move to become a global hub for healthcare innovation, the Department of Health (DH) has announced a detailed timetable...
Jul 16


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...
Jul 9


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...
Jul 8


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
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