US FDA Finalizes Guidance on Identity and Safety Information for NDINs
On October 19, 2026, final guidance from the United States Food & Drug Administration came out. Its title is New
Regulatory Updates
US FDA Amends 80 Food Standards to Support Sodium Reduction
The US Food and Drug Administration (FDA) has issued a final rule. It is allowing for safe and suitable salt
EU Medical Device Recognition in India
India now allows eligible medical devices approved in the European Union to be considered for a waiver from submitting clinical
UK AI Medical Device Regulation and Reforms
In the UK, AI medical devices fall under the Medical Devices Regulations 2002 (UK MDR 2002). The Medicines and Healthcare
Regulatory Requirements for Medical Device Sterilization in India
Three obligations are taken on by a manufacturer that supplies a sterile device in India. The process has to be
FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know
On September 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)
HSA Guidance on Class 2 CTGTP Registration in Singapore
Advanced medicines, such as cell, gene, and tissue-engineered therapies, are revolutionizing modern medicine. In Singapore, Cell, Tissue, or Gene Therapy
HSA Singapore Investigational Product Management Guidance
For locally registered products in Singapore, the management of investigational product (IP) for clinical trials is the most critical step,
Thai FDA Updates Medical Device Advertising Rules – Jan, 2025
The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License